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Efficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism

Primary Purpose

Venous Thrombosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Apixaban
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women ≥ 18 years of age;
  • Clinical diagnosis of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE);
  • Anticoagulant treatment completed
  • No recurrence of Venous Thromboembolism (VTE)

Exclusion Criteria:

  • Subjects with indications for long-term treatment with a vitamin K antagonist
  • Active bleeding or high risk for serious bleeding
  • Short life expectancy
  • Uncontrolled high blood pressure
  • Impaired kidney or liver function

Sites / Locations

  • Alabama Clinical Therapeutics, Llc
  • Cardiovascular Consultants, Ltd.
  • Robert J. Bloomberg, Md, Pc
  • Fort Smith Lung Center
  • Beaver Medical Group
  • Scripps Clinic/Scripps Health And Green Hospital
  • Healthcare Partners Medical Group
  • Mission Internal Medical Group
  • Desert Med Grp Inc, Dba Desert Oasis Healthcare Med Group
  • Indus Clinical Research Institute, Inc.
  • Kaiser Permanente Medical Center
  • Stanford University Medical Center
  • Harbor Ucla Medical Center
  • Progressive Clinical Research
  • Rocky Mountain Internal Medicine
  • New West Physicians
  • Alfieri Cardiology
  • Bay Pines Va Healthcare Systems
  • Research Alliance, Inc.
  • St. Francis Sleep Allergy & Lung Institute
  • Berma Research Group
  • Healthworx
  • Hematology Oncology Associates
  • South Miami Heart Center
  • Physicians Regional Medical Group
  • Richard A. Mclean M.D., P.A.
  • Tampa Clinical Research
  • Primary Care Of The Treasure Coast, Inc.
  • Cleveland Clinic Florida
  • Vascular Surgical Associates, Pc
  • Atlanta Institute For Medical Research, Inc
  • Gwinnett Biomedical Research
  • Boise Orthopedic Clinic
  • Saltzer Medical Group
  • Infectious Disease Of Indiana Psc
  • Office Of:Eugene C. Fletcher, Md
  • Heartland Vascular Medicine And Surgery
  • Kentucky Lung Clinic
  • Owensboro Heart & Vascular
  • Pen Bay Medical Center
  • Anne Arundel Health System Research Institute, Inc.
  • Cape Cod Research Institute
  • Henry Ford Hospital
  • William Beaumont Hospital
  • Veterans Affairs Medical Center
  • Mercury Street Medical Group, Pllc
  • Great Falls Clinic, Llp
  • Internal Medical Associates Of Grand Island, P.C
  • Creighton University Medical Center
  • Kaleida Health System
  • Goshen Medical Associates
  • Sjh Cardiology Associates
  • Richmond University Medical Center
  • New York Medical College
  • Thomas L. Ortel, Md, Phd
  • Valley Internal Medicine
  • Rex Healthcare
  • Piedmont Healthcare/Research
  • Whiteville Medical Associates, P.A.
  • Wilmington Medical Research
  • Akron General Medical Center
  • Community Health Care, Inc.
  • Valley Medical Research
  • Ohio State University Medical Center
  • Remington Davis Inc.
  • Jobst Vascular Center At The Toledo Hospital
  • Cor Clinical Research, Llc
  • Pma Medical Specialists
  • Rhode Island Hospital
  • Charleston Hematology Oncology Associates, Pa
  • Greenville Hospital System
  • Three Rivers Medical Associates, Pa
  • Clinical Research Authority, Llc
  • Palmetto Clinical Research
  • Holston Medical Group
  • Holston Medical Group
  • Amarillo Heart Clinical Research Institute Inc.
  • Corsicana Medical Research
  • Ankur Doshi, Md
  • Northwest Heart Center
  • Tanner Clinic
  • University Of Utah Hospital
  • University Of Virginia Health System
  • Sentara York Clinical Research
  • Lake Washington Vascular, Pllc
  • Franciscan Research Center
  • Medical Assoicates Inc.
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

2.5 mg

5.0 mg

0 mg

Outcomes

Primary Outcome Measures

Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation
VTE included: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.
Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation
VTE included: nonfatal DVT or nonfatal PE. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted. Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.

Secondary Outcome Measures

Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or VTE-related Death During the Intended Treatment Period - Randomized Population With Imputation
VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) -Related Death During the Intended Treatment Period - Randomized Population With Imputation
VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Composite endpoint included events that occurred any time from randomization until end of the intended treatment period, regardless of whether the participants were receiving drug treatment. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. If there were missing endpoint data, participants were imputed as having had an efficacy outcome event.
Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation
DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.
Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation
PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.
Adjudicated Venous Thromboembolism (VTE) - Related Death During the Intended Treatment Period - Randomized Population With Imputation
VTE-related death defined as: PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation).
Adjudicated Cardiovascular (CV)-Related Death During the Intended Treatment Period - Randomized Population With Imputation
CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.
Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation
DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.
Number of Participants With an Adjudicated Symptomatic Nonfatal Venous Thromboembolism (VTE) Recurrence or Death (All Cause) During the Intended Treatment Period - Randomized Participants Without Imputation
All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. First event category was the first primary event for each participant and each participant was counted once. CV-related death was presented excluding VTE-related death. In participants with event category, each participant was counted once in each event category but could have been counted in multiple categories. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.
Adjudicated Major Bleeding During the Treatment Period - Treated Population
Major bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ; or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.
Adjudicated Composite of Major/Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants
Major bleeding and clinically relevant non-major bleeding were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Major bleeding was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.
Adjudicated Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants
Non-major clinically relevant bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and defined as: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding (or lasting more than 5 minutes); spontaneous hematuria (macroscopic or lasted more than 24 hours after instrumentation of the urogenital tract); macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis (if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits.
Adjudicated Clinically Relevant Minor Bleeding During the Treatment Period - Treated Participants
All bleeding events were reviewed by the central independent adjudication committee blinded to treatment and classified as major bleeding, clinically relevant non-major bleeding, minor bleeding or no bleeding. If event was not major or clinically relevant non-major, it was judged to be minor. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.
Adjudicated Total Bleeding During the Treatment Period - Treated Participants
All bleeding events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Total bleeding was defined as any major, clinically relevant non-major, or minor bleeding. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Venous Thromboembolism-related Death During the Intended Treatment Period - Randomized Population Without Imputation
VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints.
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) - Related Death During the Intended Treatment Period - Randomized Population Without Imputation
CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event. Index events of DVT and/or PE, along with myocardial infarction and stroke were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.
Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population Without Imputation
DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.
Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population Without Imputation
PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.
Adjudicated Venous Thromboembolism (VTE)- Related Death During the Intended Treatment Period - Randomized Population Without Imputation
VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint.
Adjudicated Cardio Vascular (CV)-Related Death During the Intended Treatment Period - Randomized Population Without Imputation
CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and these were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.
Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation
DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.

Full Information

First Posted
March 5, 2008
Last Updated
October 30, 2013
Sponsor
Bristol-Myers Squibb
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00633893
Brief Title
Efficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism
Official Title
A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2711 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
2.5 mg
Arm Title
2
Arm Type
Experimental
Arm Description
5.0 mg
Arm Title
3
Arm Type
Active Comparator
Arm Description
0 mg
Intervention Type
Drug
Intervention Name(s)
Apixaban
Other Intervention Name(s)
BMS-562247
Intervention Description
Tablets, Oral, twice daily, 12 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, twice daily, 12 months
Primary Outcome Measure Information:
Title
Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation
Description
VTE included: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.
Time Frame
Day 1 up to 12 Months
Title
Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation
Description
VTE included: nonfatal DVT or nonfatal PE. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted. Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.
Time Frame
Day 1 up to 12 months
Secondary Outcome Measure Information:
Title
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or VTE-related Death During the Intended Treatment Period - Randomized Population With Imputation
Description
VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.
Time Frame
Day 1 up to 12 Months
Title
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) -Related Death During the Intended Treatment Period - Randomized Population With Imputation
Description
VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Composite endpoint included events that occurred any time from randomization until end of the intended treatment period, regardless of whether the participants were receiving drug treatment. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. If there were missing endpoint data, participants were imputed as having had an efficacy outcome event.
Time Frame
Day 1 up to 12 Months
Title
Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation
Description
DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.
Time Frame
Day 1 up to 12 Months
Title
Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation
Description
PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.
Time Frame
Day 1 up to 12 Months
Title
Adjudicated Venous Thromboembolism (VTE) - Related Death During the Intended Treatment Period - Randomized Population With Imputation
Description
VTE-related death defined as: PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation).
Time Frame
Day 1 up to 12 Months
Title
Adjudicated Cardiovascular (CV)-Related Death During the Intended Treatment Period - Randomized Population With Imputation
Description
CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.
Time Frame
Day 1 up to 12 Months
Title
Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation
Description
DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.
Time Frame
Day 1 up to 12 Months
Title
Number of Participants With an Adjudicated Symptomatic Nonfatal Venous Thromboembolism (VTE) Recurrence or Death (All Cause) During the Intended Treatment Period - Randomized Participants Without Imputation
Description
All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. First event category was the first primary event for each participant and each participant was counted once. CV-related death was presented excluding VTE-related death. In participants with event category, each participant was counted once in each event category but could have been counted in multiple categories. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.
Time Frame
Day 1 up to 12 Months
Title
Adjudicated Major Bleeding During the Treatment Period - Treated Population
Description
Major bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ; or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.
Time Frame
Day 1 up to 12 Months
Title
Adjudicated Composite of Major/Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants
Description
Major bleeding and clinically relevant non-major bleeding were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Major bleeding was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.
Time Frame
Day 1 up to 12 Months
Title
Adjudicated Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants
Description
Non-major clinically relevant bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and defined as: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding (or lasting more than 5 minutes); spontaneous hematuria (macroscopic or lasted more than 24 hours after instrumentation of the urogenital tract); macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis (if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits.
Time Frame
Day 1 up to 12 months
Title
Adjudicated Clinically Relevant Minor Bleeding During the Treatment Period - Treated Participants
Description
All bleeding events were reviewed by the central independent adjudication committee blinded to treatment and classified as major bleeding, clinically relevant non-major bleeding, minor bleeding or no bleeding. If event was not major or clinically relevant non-major, it was judged to be minor. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.
Time Frame
Day 1 up to 12 months
Title
Adjudicated Total Bleeding During the Treatment Period - Treated Participants
Description
All bleeding events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Total bleeding was defined as any major, clinically relevant non-major, or minor bleeding. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.
Time Frame
Day 1 up to 12 months
Title
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Venous Thromboembolism-related Death During the Intended Treatment Period - Randomized Population Without Imputation
Description
VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints.
Time Frame
Day 1 up to 12 Months
Title
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) - Related Death During the Intended Treatment Period - Randomized Population Without Imputation
Description
CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event. Index events of DVT and/or PE, along with myocardial infarction and stroke were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.
Time Frame
Day 1 up to 12 Months
Title
Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population Without Imputation
Description
DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.
Time Frame
Day 1 up to 12 Months
Title
Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population Without Imputation
Description
PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.
Time Frame
Day 1 up to 12 Months
Title
Adjudicated Venous Thromboembolism (VTE)- Related Death During the Intended Treatment Period - Randomized Population Without Imputation
Description
VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint.
Time Frame
Day 1 up to 12 Months
Title
Adjudicated Cardio Vascular (CV)-Related Death During the Intended Treatment Period - Randomized Population Without Imputation
Description
CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and these were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.
Time Frame
Day 1 up to 12 Months
Title
Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation
Description
DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.
Time Frame
Day 1 up to 12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women ≥ 18 years of age; Clinical diagnosis of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE); Anticoagulant treatment completed No recurrence of Venous Thromboembolism (VTE) Exclusion Criteria: Subjects with indications for long-term treatment with a vitamin K antagonist Active bleeding or high risk for serious bleeding Short life expectancy Uncontrolled high blood pressure Impaired kidney or liver function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Clinical Therapeutics, Llc
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Cardiovascular Consultants, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Robert J. Bloomberg, Md, Pc
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Fort Smith Lung Center
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72901
Country
United States
Facility Name
Beaver Medical Group
City
Banning
State/Province
California
ZIP/Postal Code
92220
Country
United States
Facility Name
Scripps Clinic/Scripps Health And Green Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Healthcare Partners Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
Facility Name
Mission Internal Medical Group
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Desert Med Grp Inc, Dba Desert Oasis Healthcare Med Group
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Indus Clinical Research Institute, Inc.
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Harbor Ucla Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Progressive Clinical Research
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Rocky Mountain Internal Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
New West Physicians
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Alfieri Cardiology
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Bay Pines Va Healthcare Systems
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Facility Name
Research Alliance, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
St. Francis Sleep Allergy & Lung Institute
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Berma Research Group
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Healthworx
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Hematology Oncology Associates
City
Loxahatchee
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
South Miami Heart Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Physicians Regional Medical Group
City
Naples
State/Province
Florida
ZIP/Postal Code
34119
Country
United States
Facility Name
Richard A. Mclean M.D., P.A.
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
Tampa Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624
Country
United States
Facility Name
Primary Care Of The Treasure Coast, Inc.
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Vascular Surgical Associates, Pc
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Atlanta Institute For Medical Research, Inc
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Gwinnett Biomedical Research
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Boise Orthopedic Clinic
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Saltzer Medical Group
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Infectious Disease Of Indiana Psc
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Office Of:Eugene C. Fletcher, Md
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Heartland Vascular Medicine And Surgery
City
Windsor Heights
State/Province
Iowa
ZIP/Postal Code
50324
Country
United States
Facility Name
Kentucky Lung Clinic
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Owensboro Heart & Vascular
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Pen Bay Medical Center
City
Rockport
State/Province
Maine
ZIP/Postal Code
04856
Country
United States
Facility Name
Anne Arundel Health System Research Institute, Inc.
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Cape Cod Research Institute
City
Hyannis
State/Province
Massachusetts
ZIP/Postal Code
02601
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Veterans Affairs Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Mercury Street Medical Group, Pllc
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Great Falls Clinic, Llp
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Internal Medical Associates Of Grand Island, P.C
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Kaleida Health System
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Facility Name
Goshen Medical Associates
City
Goshen
State/Province
New York
ZIP/Postal Code
10924
Country
United States
Facility Name
Sjh Cardiology Associates
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
Richmond University Medical Center
City
Staten Island
State/Province
New York
ZIP/Postal Code
10310
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Thomas L. Ortel, Md, Phd
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Valley Internal Medicine
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Rex Healthcare
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Piedmont Healthcare/Research
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
Whiteville Medical Associates, P.A.
City
Whiteville
State/Province
North Carolina
ZIP/Postal Code
28472
Country
United States
Facility Name
Wilmington Medical Research
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
Community Health Care, Inc.
City
Canal Fulton
State/Province
Ohio
ZIP/Postal Code
44614
Country
United States
Facility Name
Valley Medical Research
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Remington Davis Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Jobst Vascular Center At The Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Cor Clinical Research, Llc
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Pma Medical Specialists
City
Phoenixville
State/Province
Pennsylvania
ZIP/Postal Code
19460
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Charleston Hematology Oncology Associates, Pa
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Three Rivers Medical Associates, Pa
City
Irmo
State/Province
South Carolina
ZIP/Postal Code
29063
Country
United States
Facility Name
Clinical Research Authority, Llc
City
Murrells Inlet
State/Province
South Carolina
ZIP/Postal Code
29576
Country
United States
Facility Name
Palmetto Clinical Research
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Holston Medical Group
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Amarillo Heart Clinical Research Institute Inc.
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Corsicana Medical Research
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
Country
United States
Facility Name
Ankur Doshi, Md
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Northwest Heart Center
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Tanner Clinic
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
University Of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University Of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Sentara York Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
Lake Washington Vascular, Pllc
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Franciscan Research Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Medical Assoicates Inc.
City
Menomonee Falls
State/Province
Wisconsin
ZIP/Postal Code
53051
Country
United States
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Local Institution
City
Ciudad Autonoma De Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
1093 AAS
Country
Argentina
Facility Name
Local Institution
City
Ciudad Autonoma De Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
C1180AAX
Country
Argentina
Facility Name
Local Institution
City
Ciudad Autonoma De Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
C1437JCP
Country
Argentina
Facility Name
Local Institution
City
Ciudad De Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1034ACO
Country
Argentina
Facility Name
Local Institution
City
Ciudad De Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Local Institution
City
Coronel Suarez
State/Province
Buenos Aires
ZIP/Postal Code
B7540GHD
Country
Argentina
Facility Name
Local Institution
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Local Institution
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1902COI
Country
Argentina
Facility Name
Local Institution
City
Mar Del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Local Institution
City
San Martin
State/Province
Buenos Aires
ZIP/Postal Code
B1650CSQ
Country
Argentina
Facility Name
Local Institution
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000CVB
Country
Argentina
Facility Name
Local Institution
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSV
Country
Argentina
Facility Name
Local Institution
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2002KDS
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
C1122AAL
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Local Institution
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Local Institution
City
Cordoba
ZIP/Postal Code
X5000JHQ
Country
Argentina
Facility Name
Local Institution
City
Corrientes
ZIP/Postal Code
3400
Country
Argentina
Facility Name
Local Institution
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Local Institution
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Local Institution
City
Lismore
State/Province
New South Wales
ZIP/Postal Code
2480
Country
Australia
Facility Name
Local Institution
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Local Institution
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Local Institution
City
Kippa Ring
State/Province
Queensland
ZIP/Postal Code
4021
Country
Australia
Facility Name
Local Institution
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Local Institution
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Local Institution
City
Launceston
State/Province
Tasmania
ZIP/Postal Code
7250
Country
Australia
Facility Name
Local Institution
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Local Institution
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Local Institution
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Local Institution
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Local Institution
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Facility Name
Local Institution
City
Ringwood East
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
Facility Name
Local Institution
City
Windsor
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Local Institution
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Local Institution
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Local Institution
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Local Institution
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution
City
Vienna
ZIP/Postal Code
1100
Country
Austria
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
Local Institution
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40144 900
Country
Brazil
Facility Name
Local Institution
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
70335
Country
Brazil
Facility Name
Local Institution
City
Belo Horizonte - Mg
State/Province
Minas Gerais
ZIP/Postal Code
30130
Country
Brazil
Facility Name
Local Institution
City
Belo Horizonte - Mg
State/Province
Minas Gerais
ZIP/Postal Code
30150
Country
Brazil
Facility Name
Local Institution
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80030
Country
Brazil
Facility Name
Local Institution
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80050
Country
Brazil
Facility Name
Local Institution
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80810
Country
Brazil
Facility Name
Local Institution
City
Curitiba
State/Province
Parana
ZIP/Postal Code
81520
Country
Brazil
Facility Name
Local Institution
City
Rio Janeiro
State/Province
Rio De Janeiro
ZIP/Postal Code
22280
Country
Brazil
Facility Name
Local Institution
City
Port Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
9110270
Country
Brazil
Facility Name
Local Institution
City
Botucatu
State/Province
Sao Paulo
ZIP/Postal Code
18618
Country
Brazil
Facility Name
Local Institution
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13083
Country
Brazil
Facility Name
Local Institution
City
Santo Andre - Sp
State/Province
Sao Paulo
ZIP/Postal Code
09060
Country
Brazil
Facility Name
Local Institution
City
Sao Jose Do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15015
Country
Brazil
Facility Name
Local Institution
City
Sao Jose Do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090
Country
Brazil
Facility Name
Local Institution
City
Rio De Janeiro
ZIP/Postal Code
20551
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
01323
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
01509
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
04005
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
05403
Country
Brazil
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 4B9
Country
Canada
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5X 3N5
Country
Canada
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
Tsa 4l8
Country
Canada
Facility Name
Local Institution
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 9L8
Country
Canada
Facility Name
Local Institution
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
Facility Name
Local Institution
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Local Institution
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Local Institution
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Local Institution
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1M5
Country
Canada
Facility Name
Local Institution
City
Pointe- Claire
State/Province
Quebec
ZIP/Postal Code
H9R 3J1
Country
Canada
Facility Name
Local Institution
City
St. Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 5T3
Country
Canada
Facility Name
Local Institution
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Local Institution
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4781173
Country
Chile
Facility Name
Local Institution
City
Punta Arenas
State/Province
Magallanes Antartica
ZIP/Postal Code
6212296
Country
Chile
Facility Name
Local Institution
City
Independencia
State/Province
Metropolitana
ZIP/Postal Code
XXXXX
Country
Chile
Facility Name
Local Institution
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
7500520
Country
Chile
Facility Name
Local Institution
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
7600448
Country
Chile
Facility Name
Local Institution
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
7980378
Country
Chile
Facility Name
Local Institution
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8330024
Country
Chile
Facility Name
Local Institution
City
Vina Del Mar
State/Province
Valparaiso
ZIP/Postal Code
2520000
Country
Chile
Facility Name
Local Institution
City
Kladno
ZIP/Postal Code
272 59
Country
Czech Republic
Facility Name
Local Institution
City
Litomysl
ZIP/Postal Code
570 14
Country
Czech Republic
Facility Name
Local Institution
City
Mestec Kralove
ZIP/Postal Code
289 03
Country
Czech Republic
Facility Name
Local Institution
City
Ostrava Vitkovice
ZIP/Postal Code
703 00
Country
Czech Republic
Facility Name
Local Institution
City
Plzen
ZIP/Postal Code
323 33
Country
Czech Republic
Facility Name
Local Institution
City
Praha 13
ZIP/Postal Code
158 00
Country
Czech Republic
Facility Name
Local Institution
City
Praha 1
ZIP/Postal Code
110 00
Country
Czech Republic
Facility Name
Local Institution
City
Praha 1
ZIP/Postal Code
118 33
Country
Czech Republic
Facility Name
Local Institution
City
Praha 2
ZIP/Postal Code
120 00
Country
Czech Republic
Facility Name
Local Institution
City
Praha 2
ZIP/Postal Code
121 11
Country
Czech Republic
Facility Name
Local Institution
City
Praha 2
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
Local Institution
City
Praha 4
ZIP/Postal Code
140 21
Country
Czech Republic
Facility Name
Local Institution
City
Usti Nad Orlici
ZIP/Postal Code
562 18
Country
Czech Republic
Facility Name
Local Institution
City
Arhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Local Institution
City
Braedstrup
ZIP/Postal Code
8740
Country
Denmark
Facility Name
Local Institution
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Local Institution
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Local Institution
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Local Institution
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Local Institution
City
Hilleroed
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Local Institution
City
Naestved
ZIP/Postal Code
4700
Country
Denmark
Facility Name
Local Institution
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
Facility Name
Local Institution
City
Arras
ZIP/Postal Code
62022
Country
France
Facility Name
Local Institution
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Local Institution
City
Brest Cedex
ZIP/Postal Code
29609
Country
France
Facility Name
Local Institution
City
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
Local Institution
City
Clermont-Ferrand Cedex 01
ZIP/Postal Code
63003
Country
France
Facility Name
Local Institution
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Local Institution
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Local Institution
City
Le Kremlin-Bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Local Institution
City
Lille Cedex
ZIP/Postal Code
59020
Country
France
Facility Name
Local Institution
City
Limoges Cedex
ZIP/Postal Code
87042
Country
France
Facility Name
Local Institution
City
Lyon Cedex 03
ZIP/Postal Code
69437
Country
France
Facility Name
Local Institution
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Local Institution
City
Saint-Priest En Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Local Institution
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution
City
Vernon
ZIP/Postal Code
27200
Country
France
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Local Institution
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Local Institution
City
Bonn
ZIP/Postal Code
53115
Country
Germany
Facility Name
Local Institution
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Facility Name
Local Institution
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Local Institution
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
Local Institution
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Local Institution
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Local Institution
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Local Institution
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Local Institution
City
Karlsbad
ZIP/Postal Code
76307
Country
Germany
Facility Name
Local Institution
City
Krefeld
ZIP/Postal Code
47805
Country
Germany
Facility Name
Local Institution
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Local Institution
City
Mannheim
ZIP/Postal Code
68161
Country
Germany
Facility Name
Local Institution
City
Mannheim
ZIP/Postal Code
68165
Country
Germany
Facility Name
Local Institution
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Local Institution
City
Munchen
ZIP/Postal Code
80331
Country
Germany
Facility Name
Local Institution
City
Munich
ZIP/Postal Code
80336
Country
Germany
Facility Name
Local Institution
City
Hong Kong
Country
Hong Kong
Facility Name
Local Institution
City
Shatin, N.T
Country
Hong Kong
Facility Name
Local Institution
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 082
Country
India
Facility Name
Local Institution
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500034
Country
India
Facility Name
Local Institution
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Local Institution
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122001
Country
India
Facility Name
Local Institution
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
Local Institution
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
560017
Country
India
Facility Name
Local Institution
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682041
Country
India
Facility Name
Local Institution
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Local Institution
City
Mohali
State/Province
Punjab
ZIP/Postal Code
160062
Country
India
Facility Name
Local Institution
City
Ludhiana
State/Province
Tagore Nagar
ZIP/Postal Code
141001
Country
India
Facility Name
Local Institution
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600 006
Country
India
Facility Name
Local Institution
City
Ahmedabad
ZIP/Postal Code
380015
Country
India
Facility Name
Local Institution
City
Bangalore, Karnataka
ZIP/Postal Code
560034
Country
India
Facility Name
Local Institution
City
Bangalore
ZIP/Postal Code
560052
Country
India
Facility Name
Local Institution
City
Chennai
ZIP/Postal Code
600 003
Country
India
Facility Name
Local Institution
City
Chennai
ZIP/Postal Code
600 006
Country
India
Facility Name
Local Institution
City
New Dehli
ZIP/Postal Code
110025
Country
India
Facility Name
Local Institution
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Local Institution
City
Givataim
ZIP/Postal Code
53488
Country
Israel
Facility Name
Local Institution
City
Hadera
ZIP/Postal Code
38101
Country
Israel
Facility Name
Local Institution
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Local Institution
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Local Institution
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Local Institution
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Local Institution
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Local Institution
City
Kiryat Hadassah
ZIP/Postal Code
91120
Country
Israel
Facility Name
Local Institution
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Local Institution
City
Petach-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Local Institution
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Local Institution
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Local Institution
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Local Institution
City
Bollate
ZIP/Postal Code
20021
Country
Italy
Facility Name
Local Institution
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Local Institution
City
Chieti Scalo
ZIP/Postal Code
66013
Country
Italy
Facility Name
Local Institution
City
Cosenza
ZIP/Postal Code
87100
Country
Italy
Facility Name
Local Institution
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
Facility Name
Local Institution
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Local Institution
City
Genova
ZIP/Postal Code
16128
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Local Institution
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Local Institution
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Local Institution
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Facility Name
Local Institution
City
Piacenza
ZIP/Postal Code
29100
Country
Italy
Facility Name
Local Institution
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Local Institution
City
Rozzano (Mi)
ZIP/Postal Code
20089
Country
Italy
Facility Name
Local Institution
City
San Daniele Del Friuli (Ud)
ZIP/Postal Code
33038
Country
Italy
Facility Name
Local Institution
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Local Institution
City
Venezia
ZIP/Postal Code
30122
Country
Italy
Facility Name
Local Institution
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Facility Name
Local Institution
City
Vittorio Veneto (Tv)
ZIP/Postal Code
31029
Country
Italy
Facility Name
Local Institution
City
Busan
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Local Institution
City
Jongno-Gu
ZIP/Postal Code
110-774
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
120752
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
137-040
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
138736
Country
Korea, Republic of
Facility Name
Local Institution
City
Tijuana
State/Province
Baja California
ZIP/Postal Code
22500
Country
Mexico
Facility Name
Local Institution
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Local Institution
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37320
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44130
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44200
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Local Institution
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45200
Country
Mexico
Facility Name
Local Institution
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Local Institution
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Local Institution
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80020
Country
Mexico
Facility Name
Local Institution
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80230
Country
Mexico
Facility Name
Local Institution
City
Xalapa
State/Province
Veracruz
ZIP/Postal Code
91020
Country
Mexico
Facility Name
Local Institution
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Local Institution
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Facility Name
Local Institution
City
Durango
ZIP/Postal Code
34080
Country
Mexico
Facility Name
Local Institution
City
Puebla
ZIP/Postal Code
72000
Country
Mexico
Facility Name
Local Institution
City
Queretaro
ZIP/Postal Code
76000
Country
Mexico
Facility Name
Local Institution
City
San Luis Potosi
ZIP/Postal Code
78200
Country
Mexico
Facility Name
Local Institution
City
San Luis Potosi
ZIP/Postal Code
78240
Country
Mexico
Facility Name
Local Institution
City
Alesund
ZIP/Postal Code
6026
Country
Norway
Facility Name
Local Institution
City
Fredrikstad
ZIP/Postal Code
1606
Country
Norway
Facility Name
Local Institution
City
Gjettum
ZIP/Postal Code
1346
Country
Norway
Facility Name
Local Institution
City
Gjovik
ZIP/Postal Code
2819
Country
Norway
Facility Name
Local Institution
City
Hamar
ZIP/Postal Code
2318
Country
Norway
Facility Name
Local Institution
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Facility Name
Local Institution
City
Cavite
ZIP/Postal Code
4114
Country
Philippines
Facility Name
Local Institution
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Local Institution
City
Pasig City
ZIP/Postal Code
1600
Country
Philippines
Facility Name
Local Institution
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Local Institution
City
Arkonska 4
ZIP/Postal Code
71455
Country
Poland
Facility Name
Local Institution
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Local Institution
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Local Institution
City
Bydgoszcz
ZIP/Postal Code
85-650
Country
Poland
Facility Name
Local Institution
City
Bydgoszcz
ZIP/Postal Code
85-681
Country
Poland
Facility Name
Local Institution
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Local Institution
City
Gdynia
ZIP/Postal Code
81-348
Country
Poland
Facility Name
Local Institution
City
Gdynia
ZIP/Postal Code
81-423
Country
Poland
Facility Name
Local Institution
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Local Institution
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Local Institution
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Local Institution
City
Poznan
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Local Institution
City
Przeworsk
ZIP/Postal Code
37-200
Country
Poland
Facility Name
Local Institution
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Local Institution
City
Tarnobrzeg
ZIP/Postal Code
39-400
Country
Poland
Facility Name
Local Institution
City
Warsawa
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Local Institution
City
Warsaw
ZIP/Postal Code
01-809
Country
Poland
Facility Name
Local Institution
City
Warsaw
ZIP/Postal Code
02-005
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
01-138
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
02-018
Country
Poland
Facility Name
Local Institution
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Local Institution
City
Wroclaw
ZIP/Postal Code
53-114
Country
Poland
Facility Name
Local Institution
City
Guarda
ZIP/Postal Code
6301-857
Country
Portugal
Facility Name
Local Institution
City
Lisboa
ZIP/Postal Code
1769-001
Country
Portugal
Facility Name
Local Institution
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Local Institution
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico
Facility Name
Local Institution
City
Baia Mare
ZIP/Postal Code
430031
Country
Romania
Facility Name
Local Institution
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Local Institution
City
Bucharest
ZIP/Postal Code
030171
Country
Romania
Facility Name
Local Institution
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
Local Institution
City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Local Institution
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Local Institution
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
Facility Name
Local Institution
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Facility Name
Local Institution
City
Novosibirsk
ZIP/Postal Code
630090
Country
Russian Federation
Facility Name
Local Institution
City
Rostov-On Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Local Institution
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
Local Institution
City
Saint Petersburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
Local Institution
City
Saint-Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Local Institution
City
Saint-Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Local Institution
City
Samara
ZIP/Postal Code
443010
Country
Russian Federation
Facility Name
Local Institution
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Local Institution
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Local Institution
City
St Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Local Institution
City
Tomsk
ZIP/Postal Code
634012
Country
Russian Federation
Facility Name
Local Institution
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Local Institution
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Local Institution
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Local Institution
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Local Institution
City
Centurion
State/Province
Gauteng
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Local Institution
City
Parktown
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Local Institution
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0083
Country
South Africa
Facility Name
Local Institution
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0084
Country
South Africa
Facility Name
Local Institution
City
Durban
State/Province
Kwa Zulu Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Local Institution
City
Pietermaritzburg
State/Province
Kwa Zulu Natal
ZIP/Postal Code
3201
Country
South Africa
Facility Name
Local Institution
City
Bellville
State/Province
Western Cape
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Local Institution
City
George
State/Province
Western Cape
ZIP/Postal Code
6529
Country
South Africa
Facility Name
Local Institution
City
Somerset West
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Local Institution
City
Worcester
State/Province
Western Cape
ZIP/Postal Code
6850
Country
South Africa
Facility Name
Local Institution
City
Torrevieja
State/Province
Alicante
ZIP/Postal Code
03186
Country
Spain
Facility Name
Local Institution
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Local Institution
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Local Institution
City
San Sebastian De Los Reyes
State/Province
Madrid
ZIP/Postal Code
28702
Country
Spain
Facility Name
Local Institution
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Local Institution
City
Getafe
ZIP/Postal Code
28905
Country
Spain
Facility Name
Local Institution
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Local Institution
City
L'Hospitalet De Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Local Institution
City
Leon
ZIP/Postal Code
24008
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28029
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution
City
Mourente
ZIP/Postal Code
36071
Country
Spain
Facility Name
Local Institution
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Local Institution
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Local Institution
City
Sant Boi De Llobregat
ZIP/Postal Code
08830
Country
Spain
Facility Name
Local Institution
City
Tarragona
ZIP/Postal Code
43007
Country
Spain
Facility Name
Local Institution
City
Toledo
ZIP/Postal Code
45071
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Local Institution
City
Chernihiv
ZIP/Postal Code
14034
Country
Ukraine
Facility Name
Local Institution
City
Dnipropetrovsk
ZIP/Postal Code
49000
Country
Ukraine
Facility Name
Local Institution
City
Donetsk
ZIP/Postal Code
83045
Country
Ukraine
Facility Name
Local Institution
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Local Institution
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Local Institution
City
Kharkiv
ZIP/Postal Code
61018
Country
Ukraine
Facility Name
Local Institution
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Local Institution
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Local Institution
City
Odesa
ZIP/Postal Code
65117
Country
Ukraine
Facility Name
Local Institution
City
Ternopil
ZIP/Postal Code
46000
Country
Ukraine
Facility Name
Local Institution
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Local Institution
City
Zaporizhzhia
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
Local Institution
City
Aberdeen
State/Province
Aberdeenshire
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Local Institution
City
Romford
State/Province
Essex
ZIP/Postal Code
RM7 0AG
Country
United Kingdom
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Local Institution
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Local Institution
City
Hull
State/Province
Humberside
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Local Institution
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Local Institution
City
Bury St. Edmunds
State/Province
Suffolk
ZIP/Postal Code
IP30 9QU
Country
United Kingdom
Facility Name
Local Institution
City
Coventry
State/Province
West Midlands
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Local Institution
City
Dudley
State/Province
West Midlands
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35570249
Citation
Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16.
Results Reference
derived
PubMed Identifier
26446706
Citation
Liu X, Thompson J, Phatak H, Mardekian J, Porcari A, Johnson M, Cohen AT. Extended anticoagulation with apixaban reduces hospitalisations in patients with venous thromboembolism. An analysis of the AMPLIFY-EXT trial. Thromb Haemost. 2016 Jan;115(1):161-8. doi: 10.1160/TH15-07-0606. Epub 2015 Oct 8.
Results Reference
derived
PubMed Identifier
23216615
Citation
Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Porcari A, Raskob GE, Weitz JI; AMPLIFY-EXT Investigators. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):699-708. doi: 10.1056/NEJMoa1207541. Epub 2012 Dec 8.
Results Reference
derived

Learn more about this trial

Efficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism

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