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Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness (ADOPT)

Primary Purpose

Venous Thrombosis, Pulmonary Embolism

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Apixaban

Enoxaparin

About this trial

This is an interventional prevention trial for Venous Thrombosis focused on measuring Prevention of deep vein thrombosis and pulmonary embolism with acutely ill hospitalized patients

Eligibility Criteria

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

Inclusion Criteria:

men and non-pregnant, non-breastfeeding women
40 years or older
hospitalized with congestive heart failure or acute respiratory failure
infection (without septic shock)
acute rheumatic disorder
inflammatory bowel disease

Exclusion Criteria:

patients with venous thromboembolism (VTE)
active bleeding or at high risk of bleeding
unable to take oral medication
with diseases requiring ongoing treatment with anticoagulants or antiplatelets other than aspirin at a dose ≤ 165 mg/day.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

While hospitalized, Apixaban plus Placebo Apixaban (Tablets, Oral, 2.5 mg), Placebo (Syringes, SC) After hospital discharge, Apixaban Apixaban (Tablets, Oral, 2.5 mg)

While hospitalized, Enoxaparin plus Placebo Enoxaparin (Syringes, SC, 40 mg), Placebo (Tablets, Oral) After hospital discharge: Placebo Placebo (Tablets, Oral)

Outcomes

Primary Outcome Measures

Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population

VTE: nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE could not be excluded as a cause. Intended Treatment Period=period that started on day of randomization: period ended (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; period ended (for not treated) 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. All efficacy events were adjudicated by the Independent Central Adjudication Committee (ICAC). Event rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

Incidence of Major Bleeding During the Treatment Period in Treated Participants

Major bleeding was adjudicated by an ICAC using criteria from the International Society on Thrombosis and Hemostasis (ISTH) 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 bleeding in a critical site or bleeding which is fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants

Bleeding was adjudicated by an ICAC using criteria from the ISTH. CRNM bleeding: 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; spontaneous hematuria; 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. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants

Bleeding was adjudicated by an ICAC using criteria from the ISTH. Major bleeding: 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 bleeding in a critical site or bleeding which is fatal. CRNM bleeding: 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; spontaneous hematuria; macroscopic gastrointestinal hemorrhage; rectal blood loss. Treatment Period=onset from first dose of study drug through 2 days after last dose of study drugs. Incidence: Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

Incidence of All Bleeding During the Treatment Period in Treated Participants

Bleeding was adjudicated by an ICAC using criteria from the ISTH. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs, for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

Secondary Outcome Measures

Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants

Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Key Secondary Efficacy population: all who received at least 1 dose of parenteral study drug and: (those without suspected VTE events during Parenteral Treatment) had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or (those with suspected VTE events during Parenteral Treatment) had those suspected VTE events adjudicated as non-events, and had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or had an adjudicated total VTE during Parenteral Treatment; or had an adjudicated VTE-related death during Parenteral Treatment. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants).

Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Secondary Efficacy Evaluable Participants

Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Secondary Efficacy Evaluable includes those who had an adjudicated, evaluable ultrasound at end of parenteral treatment and for those with a suspected symptomatic event, the result of the adjudication for the symptomatic event was not inadequate; or those with an adjudicated event that was part of the composite endpoint.. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants).

Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period

Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal (N-F) PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. All-Cause Death (A-C Death). Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period

Incidence of Adjudicated Proximal DVT, Non-Fatal PE or VTE-Related Death, With Onset During the Intended Treatment Period

Incidence of Adjudicated VTE-Related Death With Onset During the Intended Treatment Period in Randomized Participants

Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period

Symptomatic Adjudicated VTE or VTE-Related Death With Onset During the Intended Treatment Period

Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period

Incidence of Adjudicated PE With Onset During the Intended Treatment Period

Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period

Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period

Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period

Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period

Events were adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period

Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period

A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants

Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for AEs, and 30 days after last dose of study drugs for SAEs and deaths.

Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period

Diastolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken with the participant either sitting, standing, or supine.

Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period

Systolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken either sitting, standing, or supine.

Mean Change From Baseline in Heart Rate in Treated Participants

Heart Rate was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Heart rate was measured in beats per minute (bpm) and could have been taken with participants either sitting, standing, or supine.

Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants

Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). Absolute (Abs). Hemoglobin: >2 g/dL decrease compared to PreRx value or value <=8 g/dL; Hematocrit: <0.75*PreRx; Erythrocytes: <0.75*PreRx c/µL; Leukocytes: <0.75*LLN or > 1.25*ULN, if PreRx <LLN then use <0.8*PreRx or >ULN, if PreRx >ULN then use >1.2*PreRx or < LLN; Platelet count: < 100*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.75*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes > 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL or > 7.5*10^3 c/ µL. Samples were obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.

Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants

Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if PreRx < LLN then use < 0.75* PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if PreRx < LLN then use < 0.75*PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if PreRx < LLN then use < 0.95*PreRx or > ULN if PreRx > ULN then use > 1.05*PreRx or < LLN. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.

Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants

Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN. Samples for laboratories obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.

Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants

Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if PreRx < LLN then use 0.9* PreRx or > ULN if PreRx > ULN then use 1.1 *PreRx or <LLN; Uric acid High: > 1.5* ULN, or if PreRx > ULN then use > 2 *PreRx. Glucose Fasting: <0.9*LLN or > 1.5*ULN or if PreRx < LLN then use < 0.8*PreRx or > ULN, if PreRx > ULN then use >2.0*PreRx. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) ± 2days.

Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants

Events of Special Interest include: adjudicated thrombocytopenia, adjudicated myocardial infarction (MI), adjudicated stroke, and adjudicated MI or stroke. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs.

Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements

Special interest include: liver function test increases, AEs related to liver function, and neurologic AEs. Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drug when summarizing AEs and through 30 days after the last dose when summarizing SAEs.

Number of Participants With Liver-Related Elevations During the Treatment Period in Treated Participants

Liver function tests: Alanine aminotransferase (ALT) U/L; Aspartate aminotransferase (AST) U/L; Alkaline phosphatase U/L; Total Bilirubin (TBili) mg/dL. Elevations consist of >3*Upper Limit of Normal (ULN) for ALT and AST and elevation of >2*ULN for Bilirubin.

Full Information

NCT ID

NCT00457002

First Posted

April 4, 2007

Last Updated

December 7, 2015

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00457002

Brief Title

Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness

Acronym

ADOPT

Official Title

A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.

6. Conditions and Keywords

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

Venous Thrombosis, Pulmonary Embolism

Keywords

Prevention of deep vein thrombosis and pulmonary embolism with acutely ill hospitalized patients

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

6758 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

While hospitalized, Apixaban plus Placebo Apixaban (Tablets, Oral, 2.5 mg), Placebo (Syringes, SC) After hospital discharge, Apixaban Apixaban (Tablets, Oral, 2.5 mg)

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Description

While hospitalized, Enoxaparin plus Placebo Enoxaparin (Syringes, SC, 40 mg), Placebo (Tablets, Oral) After hospital discharge: Placebo Placebo (Tablets, Oral)

Intervention Type

Drug

Intervention Name(s)

Apixaban

Other Intervention Name(s)

BMS-562247

Intervention Description

Apixaban: Twice daily, 30 days Placebo: Once daily, 6-14 days

Intervention Type

Drug

Intervention Name(s)

Enoxaparin

Intervention Description

Enoxaparin: Once daily, 6-14 days Placebo: Twice daily, 30 days

Primary Outcome Measure Information:

Title

Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population

Description

Time Frame

Intended Treatment Period

Title

Incidence of Major Bleeding During the Treatment Period in Treated Participants

Description

Time Frame

Day 1, first dose of study drug, to last dose of study drug plus 2 days

Title

Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants

Description

Time Frame

Day 1, first dose of study drug, to last dose of study drug plus 2 days

Title

Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants

Description

Time Frame

Day 1, first dose of study drug, to last dose of study drug plus 2 days

Title

Incidence of All Bleeding During the Treatment Period in Treated Participants

Description

Time Frame

Day 1, first dose of drug to last dose of drug plus 2 days

Secondary Outcome Measure Information:

Title

Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants

Description

Time Frame

Day 1 to last dose of parenteral study drug plus 1 day

Title

Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Secondary Efficacy Evaluable Participants

Description

Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Secondary Efficacy Evaluable includes those who had an adjudicated, evaluable ultrasound at end of parenteral treatment and for those with a suspected symptomatic event, the result of the adjudication for the symptomatic event was not inadequate; or those with an adjudicated event that was part of the composite endpoint.. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants).

Time Frame

Day 1 to last dose of parenteral study drug plus 1 day

Title

Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period

Description

Time Frame

Intended Treatment Period

Title

Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period

Description

Time Frame

Intended Treatment Period

Title

Incidence of Adjudicated Proximal DVT, Non-Fatal PE or VTE-Related Death, With Onset During the Intended Treatment Period

Description

Time Frame

Intended Treatment Period

Title

Incidence of Adjudicated VTE-Related Death With Onset During the Intended Treatment Period in Randomized Participants

Description

Time Frame

Intended Treatment Period

Title

Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period

Description

Time Frame

Intended Treatment Period

Title

Symptomatic Adjudicated VTE or VTE-Related Death With Onset During the Intended Treatment Period

Description

Time Frame

Intended Treatment Period

Title

Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period

Description

Time Frame

Intended Treatment Period

Title

Incidence of Adjudicated PE With Onset During the Intended Treatment Period

Description

Time Frame

Intended Treatment Period

Title

Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period

Description

Time Frame

Intended Treatment Period

Title

Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period

Description

Time Frame

Intended Treatment Period

Title

Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period

Description

Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

Time Frame

Intended Treatment Period

Title

Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period

Description

Time Frame

Intended Treatment Period

Title

Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period

Description

Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).

Time Frame

Intended Treatment Period

Title

Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period

Description

Time Frame

Intended Treatment Period

Title

Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants

Description

Time Frame

Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths)

Title

Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period

Description

Time Frame

Day 1 to last dose of study drug plus 2 days

Title

Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period

Description

Time Frame

Day 1 to last dose of study drug plus 2 days

Title

Mean Change From Baseline in Heart Rate in Treated Participants

Description

Time Frame

Day 1 to last dose of study drug plus 2 days

Title

Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants

Description

Time Frame

Day 1 to last dose of study drug plus 2 days

Title

Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants

Description

Time Frame

Day 1 to last dose of study drug plus 2 days

Title

Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants

Description

Time Frame

Day 1 to last dose of study drug plus 2 days

Title

Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants

Description

Time Frame

Day 1 to last dose of study drug plus 2 days

Title

Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants

Description

Time Frame

Day 1 to last dose of study drug plus 2 days

Title

Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements

Description

Time Frame

Day 1 to last dose of study drug plus 2 days (AEs) and plus 30 days (SAEs)

Title

Number of Participants With Liver-Related Elevations During the Treatment Period in Treated Participants

Description

Time Frame

Day 1 to last dose of study drug plus 2 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: men and non-pregnant, non-breastfeeding women 40 years or older hospitalized with congestive heart failure or acute respiratory failure infection (without septic shock) acute rheumatic disorder inflammatory bowel disease Exclusion Criteria: patients with venous thromboembolism (VTE) active bleeding or at high risk of bleeding unable to take oral medication with diseases requiring ongoing treatment with anticoagulants or antiplatelets other than aspirin at a dose ≤ 165 mg/day.

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

University Of Alabama At Birmingham Hospital

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Heart Center Research, Llc

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Arizona Pulmonary Specialists, Ltd.

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

Facility Name

Az Pulmonary Specialists Ltd

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Facility Name

Fort Smith Lung Center

City

Fort Smith

State/Province

Arkansas

ZIP/Postal Code

72901

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

Va Long Beach Healthcare System

City

Long Beach

State/Province

California

ZIP/Postal Code

90822

Country

United States

Facility Name

Univ. Of Southern Calif. /Norris Comprehensive Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Dr. Felt Medical Office

City

Oakland

State/Province

California

ZIP/Postal Code

94609

Country

United States

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Yale University School Of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

Norwalk Hospital

City

Norwalk

State/Province

Connecticut

ZIP/Postal Code

06856

Country

United States

Facility Name

George Washington University

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

Facility Name

Florida Hospital Celebration Health

City

Celebration

State/Province

Florida

ZIP/Postal Code

34747

Country

United States

Facility Name

Research Alliance, Inc.

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Jacksonville Center For Clinical Research

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Pensacola Lung Group

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32504

Country

United States

Facility Name

Indian River Med. Ctr.

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

Atlanta Institute For Medical Research, Inc

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30030

Country

United States

Facility Name

Pulmonary & Critical Care Of Atlanta

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Idaho Falls Infectious Diseases, Pllc

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

West Suburban Hospital

City

Oak Park

State/Province

Illinois

ZIP/Postal Code

60302

Country

United States

Facility Name

Infectious Disease Of Indiana Psc

City

Carmel

State/Province

Indiana

ZIP/Postal Code

46032

Country

United States

Facility Name

Cotton-O-Neil Clinical Research Center

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66604

Country

United States

Facility Name

Louisiana State University Health Sciences Center-Shreveport

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71103

Country

United States

Facility Name

Johns Hopkins University School Of Medicine

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Facility Name

Franklin Square Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21237

Country

United States

Facility Name

Henry Ford Hospital, Transplant Institute

City

Detriot

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

University Of Missouri-Columbia

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65212

Country

United States

Facility Name

Mercury Street Medical Group, Pllc

City

Butte

State/Province

Montana

ZIP/Postal Code

59701

Country

United States

Facility Name

Creighton University Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

Morristown Memorial Hospital

City

Mornstown

State/Province

New Jersey

ZIP/Postal Code

07962

Country

United States

Facility Name

North Shore University Hospital

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

Facility Name

Staten Island University Hospital

City

Staten Island

State/Province

New York

ZIP/Postal Code

10305

Country

United States

Facility Name

Mission Hospital, Inc

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

Country

United States

Facility Name

South Oklahoma Heart Research

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73135

Country

United States

Facility Name

Lehigh Valley Hospital

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18103

Country

United States

Facility Name

The Milton S Hershey Medical Center Of Penn. State Univ.

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Palmetto Nephrology Pa

City

Orangeburg

State/Province

South Carolina

ZIP/Postal Code

29118

Country

United States

Facility Name

S. Carolina Pharmaceutical Research

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

Texas Health Presbyterian Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Michael E. De Bakey Veteran Affairs Medical Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Sonterra Clinical Research

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78205

Country

United States

Facility Name

Sonterra Clinical Research

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78258

Country

United States

Facility Name

Intermountain Medical Center

City

Murray

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

University Of Utah Medical Center

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

Mcguire Va Medical Center

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23249

Country

United States

Facility Name

Local Institution

City

Ciudad Autonoma Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1280AEB

Country

Argentina

Facility Name

Local Institution

City

Coronel Suarez

State/Province

Buenos Aires

ZIP/Postal Code

B7540GHD

Country

Argentina

Facility Name

Local Institution

City

Derqui-Pilar

State/Province

Buenos Aires

ZIP/Postal Code

B1629ODT

Country

Argentina

Facility Name

Local Institution

City

La Plata

State/Province

Buenos Aires

ZIP/Postal Code

1900

Country

Argentina

Facility Name

Local Institution

City

Munro

State/Province

Buenos Aires

ZIP/Postal Code

B1605DSX

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

2000

Country

Argentina

Facility Name

Local Institution

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2002KDS

Country

Argentina

Facility Name

Local Institution

City

San Miguel De Tucuman

State/Province

Tucuman

ZIP/Postal Code

T4000JCU

Country

Argentina

Facility Name

Local Institution

City

Buenos Aires

ZIP/Postal Code

C1181ACH

Country

Argentina

Facility Name

Local Institution

City

Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Local Institution

City

Cordoba

ZIP/Postal Code

X5006IKK

Country

Argentina

Facility Name

Local Institution

City

Corrientes

ZIP/Postal Code

3400

Country

Argentina

Facility Name

Local Institution

City

Concord

State/Province

New South Wales

ZIP/Postal Code

2139

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

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

Bedford Park

State/Province

South Australia

ZIP/Postal Code

5042

Country

Australia

Facility Name

Local Institution

City

Woodville

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

Facility Name

Local Institution

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

Local Institution

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Local Institution

City

Ringwood East

State/Province

Victoria

ZIP/Postal Code

3135

Country

Australia

Facility Name

Local Institution

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Local Institution

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Local Institution

City

Ottignies

State/Province

Waals-Brabant

ZIP/Postal Code

1340

Country

Belgium

Facility Name

Local Institution

City

Antwerpen

ZIP/Postal Code

2060

Country

Belgium

Facility Name

Local Institution

City

Brasschaat

ZIP/Postal Code

2930

Country

Belgium

Facility Name

Local Institution

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Local Institution

City

Huy

ZIP/Postal Code

4500

Country

Belgium

Facility Name

Local Institution

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Local Institution

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30150

Country

Brazil

Facility Name

Local Institution

City

Curitiba

State/Province

Parana

ZIP/Postal Code

80010

Country

Brazil

Facility Name

Local Institution

City

Curitiba

State/Province

Parana

ZIP/Postal Code

80810

Country

Brazil

Facility Name

Local Institution

City

Porto 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

91430

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

13059

Country

Brazil

Facility Name

Local Institution

City

Sao Jose Do Rio Preto

State/Province

Sao Paulo

ZIP/Postal Code

15091

Country

Brazil

Facility Name

Local Institution

City

Sao Paulo

ZIP/Postal Code

04012

Country

Brazil

Facility Name

Local Institution

City

Sao Paulo

ZIP/Postal Code

04020

Country

Brazil

Facility Name

Local Institution

City

Sao Paulo

ZIP/Postal Code

04025

Country

Brazil

Facility Name

Local Institution

City

Sao Paulo

ZIP/Postal Code

05403

Country

Brazil

Facility Name

Local Institution

City

Ajax

State/Province

Ontario

ZIP/Postal Code

L1S 7K8

Country

Canada

Facility Name

Local Institution

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

Facility Name

Local Institution

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Facility Name

Local Institution

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8X 5A6

Country

Canada

Facility Name

Local Institution

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N9A 1C9

Country

Canada

Facility Name

Local Institution

City

Granby

State/Province

Quebec

ZIP/Postal Code

J2G 1T7

Country

Canada

Facility Name

Local Institution

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2H1

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

H2L 4M1

Country

Canada

Facility Name

Local Institution

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

Local Institution

City

Temuco

State/Province

Araucania

ZIP/Postal Code

- - - - -

Country

Chile

Facility Name

Local Institution

City

Santiago

State/Province

Metropolitana

ZIP/Postal Code

7500922

Country

Chile

Facility Name

Local Institution

City

Santiago

State/Province

Metropolitana

ZIP/Postal Code

8207257

Country

Chile

Facility Name

Local Institution

City

Rancagua

State/Province

Valparaiso

Country

Chile

Facility Name

Local Institution

City

Bogota

Country

Colombia

Facility Name

Local Institution

City

Bucaramanga

Country

Colombia

Facility Name

Local Institution

City

Medellin

Country

Colombia

Facility Name

Local Institution

City

Brno

ZIP/Postal Code

656 91

Country

Czech Republic

Facility Name

Local Institution

City

Jindrichuv Hradec

ZIP/Postal Code

377 38

Country

Czech Republic

Facility Name

Local Institution

City

Kladno

ZIP/Postal Code

272 59

Country

Czech Republic

Facility Name

Local Institution

City

Kyjov

ZIP/Postal Code

697 01

Country

Czech Republic

Facility Name

Local Institution

City

Ostrava

ZIP/Postal Code

728 80

Country

Czech Republic

Facility Name

Local Institution

City

Prague 2

ZIP/Postal Code

128 08

Country

Czech Republic

Facility Name

Local Institution

City

Praha 1

ZIP/Postal Code

110 00

Country

Czech Republic

Facility Name

Local Institution

City

Praha 5

ZIP/Postal Code

150 06

Country

Czech Republic

Facility Name

Local Institution

City

Usti Nad Labem

ZIP/Postal Code

401 13

Country

Czech Republic

Facility Name

Local Institution

City

Aalborg

ZIP/Postal Code

9100

Country

Denmark

Facility Name

Local Institution

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Local Institution

City

Arhus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Local Institution

City

Frederiksberg

ZIP/Postal Code

2000

Country

Denmark

Facility Name

Local Institution

City

Glostrup

ZIP/Postal Code

2600

Country

Denmark

Facility Name

Local Institution

City

Hellerup

ZIP/Postal Code

2900

Country

Denmark

Facility Name

Local Institution

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Local Institution

City

Herning

ZIP/Postal Code

7400

Country

Denmark

Facility Name

Local Institution

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Name

Local Institution

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Local Institution

City

Randers No

ZIP/Postal Code

8930

Country

Denmark

Facility Name

Local Institution

City

Silkeborg

ZIP/Postal Code

8600

Country

Denmark

Facility Name

Local Institution

City

Bordeaux

ZIP/Postal Code

33075

Country

France

Facility Name

Local Institution

City

Brest Cedex

ZIP/Postal Code

29609

Country

France

Facility Name

Local Institution

City

Brest

ZIP/Postal Code

29200

Country

France

Facility Name

Local Institution

City

Dijon Cedex

ZIP/Postal Code

21079

Country

France

Facility Name

Local Institution

City

Grenoble Cedex 9

ZIP/Postal Code

38043

Country

France

Facility Name

Local Institution

City

Lille Cedex

ZIP/Postal Code

59020

Country

France

Facility Name

Local Institution

City

Nancy

ZIP/Postal Code

54035

Country

France

Facility Name

Local Institution

City

Nimes Cedex 9

ZIP/Postal Code

30029

Country

France

Facility Name

Local Institution

City

Paris Cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

Local Institution

City

Paris Cedex 15

ZIP/Postal Code

75908

Country

France

Facility Name

Local Institution

City

Saint Etienne Cedex 02

ZIP/Postal Code

42055

Country

France

Facility Name

Local Institution

City

Vernon

ZIP/Postal Code

27207

Country

France

Facility Name

Local Institution

City

Bonn

ZIP/Postal Code

53127

Country

Germany

Facility Name

Local Institution

City

Coburg

ZIP/Postal Code

96450

Country

Germany

Facility Name

Local Institution

City

Darmstadt

ZIP/Postal Code

64283

Country

Germany

Facility Name

Local Institution

City

Dresden

ZIP/Postal Code

01099

Country

Germany

Facility Name

Local Institution

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Local Institution

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Local Institution

City

Karlsbad

ZIP/Postal Code

76307

Country

Germany

Facility Name

Local Institution

City

Luebeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Local Institution

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

Local Institution

City

Offenbach

ZIP/Postal Code

63069

Country

Germany

Facility Name

Local Institution

City

Witten

ZIP/Postal Code

58455

Country

Germany

Facility Name

Local Institution

City

Shatin, N.T.

Country

Hong Kong

Facility Name

Local Institution

City

Budapest

ZIP/Postal Code

1135

Country

Hungary

Facility Name

Local Institution

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Local Institution

City

Dunaujvaros

ZIP/Postal Code

2400

Country

Hungary

Facility Name

Local Institution

City

Eger

ZIP/Postal Code

3300

Country

Hungary

Facility Name

Local Institution

City

Vishakapatnam

State/Province

Andhra-Pradesh

ZIP/Postal Code

530002

Country

India

Facility Name

Local Institution

City

Hyderabad

State/Province

Andra Pradesh

ZIP/Postal Code

500004

Country

India

Facility Name

Local Institution

City

Ahemdabad

State/Province

Gujarat

ZIP/Postal Code

380054

Country

India

Facility Name

Local Institution

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560034

Country

India

Facility Name

Local Institution

City

Indore

State/Province

Madhya Pardesh

ZIP/Postal Code

452018

Country

India

Facility Name

Local Institution

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411001

Country

India

Facility Name

Local Institution

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411004

Country

India

Facility Name

Local Institution

City

Pune

State/Province

Maharastra

ZIP/Postal Code

411001

Country

India

Facility Name

Local Institution

City

Ludhiana

State/Province

Punjab

ZIP/Postal Code

141001

Country

India

Facility Name

Local Institution

City

Coimbatore

State/Province

Tamil Nadu

ZIP/Postal Code

641004

Country

India

Facility Name

Local Institution

City

Madurai

State/Province

Tamil Nadu

ZIP/Postal Code

625107

Country

India

Facility Name

Local Institution

City

Chennai

State/Province

Tamil-Nadu

ZIP/Postal Code

600096

Country

India

Facility Name

Local Institution

City

Noida

State/Province

Uttar Pradesh

ZIP/Postal Code

201301

Country

India

Facility Name

Local Institution

City

Ahmedabad

ZIP/Postal Code

380054

Country

India

Facility Name

Local Institution

City

Bangalore

ZIP/Postal Code

560017

Country

India

Facility Name

Local Institution

City

Bangalore

ZIP/Postal Code

560054

Country

India

Facility Name

Local Institution

City

Hyderabad

ZIP/Postal Code

500033

Country

India

Facility Name

Local Institution

City

Mumbai

ZIP/Postal Code

400008

Country

India

Facility Name

Local Institution

City

New Delhi

ZIP/Postal Code

110025

Country

India

Facility Name

Local Institution

City

Afula

ZIP/Postal Code

18101

Country

Israel

Facility Name

Local Institution

City

Ashkelon

ZIP/Postal Code

78308

Country

Israel

Facility Name

Local Institution

City

Beer Sheva

ZIP/Postal Code

84105

Country

Israel

Facility Name

Local Institution

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Local Institution

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Local Institution

City

Safed

ZIP/Postal Code

13110

Country

Israel

Facility Name

Local Institution

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

Local Institution

City

Tel-Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Local Institution

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

Local Institution

City

Chieti Scalo

ZIP/Postal Code

66013

Country

Italy

Facility Name

Local Institution

City

Cremona

ZIP/Postal Code

26100

Country

Italy

Facility Name

Local Institution

City

Padua

ZIP/Postal Code

35128

Country

Italy

Facility Name

Local Institution

City

Piacenza

ZIP/Postal Code

29100

Country

Italy

Facility Name

Local Institution

City

Reggio Emilia

ZIP/Postal Code

42100

Country

Italy

Facility Name

Local Institution

City

Treviso

ZIP/Postal Code

31100

Country

Italy

Facility Name

Local Institution

City

Vicenza

ZIP/Postal Code

36100

Country

Italy

Facility Name

Local Institution

City

Guri-Si

State/Province

Gyeonggi-Do

ZIP/Postal Code

471-701

Country

Korea, Republic of

Facility Name

Local Institution

City

Seongnam-Si

State/Province

Gyeonggi-Do

ZIP/Postal Code

463-707

Country

Korea, Republic of

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

120-752

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

136-705

Country

Korea, Republic of

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

137-040

Country

Korea, Republic of

Facility Name

Local Institution

City

Suwon

ZIP/Postal Code

443721

Country

Korea, Republic of

Facility Name

Local Institution

City

Kubang Kerian

State/Province

Kelantan

ZIP/Postal Code

16150

Country

Malaysia

Facility Name

Local Institution

City

Batu Caves

State/Province

Selangor

ZIP/Postal Code

68100

Country

Malaysia

Facility Name

Local Institution

City

Johor Bahru

ZIP/Postal Code

80100

Country

Malaysia

Facility Name

Local Institution

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

06726

Country

Mexico

Facility Name

Local Institution

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

07760

Country

Mexico

Facility Name

Local Institution

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Local Institution

City

Xalapa

State/Province

Veracruz

ZIP/Postal Code

91020

Country

Mexico

Facility Name

Local Institution

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97129

Country

Mexico

Facility Name

Local Institution

City

Queretaro

ZIP/Postal Code

76178

Country

Mexico

Facility Name

Local Institution

City

San Luis Potosi

ZIP/Postal Code

78220

Country

Mexico

Facility Name

Local Institution

City

Den Helder

ZIP/Postal Code

1782 GZ

Country

Netherlands

Facility Name

Local Institution

City

Kongsvinger

ZIP/Postal Code

2226

Country

Norway

Facility Name

Local Institution

City

La Victoria

State/Province

Lima

ZIP/Postal Code

LIMA 13

Country

Peru

Facility Name

Local Institution

City

Arequipa

ZIP/Postal Code

AREQUIPA54

Country

Peru

Facility Name

Local Institution

City

Callao

ZIP/Postal Code

CALLAO 2

Country

Peru

Facility Name

Local Institution

City

Lima

ZIP/Postal Code

LIMA 01

Country

Peru

Facility Name

Local Institution

City

Lima

ZIP/Postal Code

LIMA 11

Country

Peru

Facility Name

Local Institution

City

Lima

ZIP/Postal Code

LIMA 1

Country

Peru

Facility Name

Local Institution

City

Lima

ZIP/Postal Code

LIMA 31

Country

Peru

Facility Name

Local Institution

City

Cagayan De Oro City

State/Province

Misamis Oriental

ZIP/Postal Code

9000

Country

Philippines

Facility Name

Local Institution

City

Las Pinas

ZIP/Postal Code

1742

Country

Philippines

Facility Name

Local Institution

City

Quezon City

ZIP/Postal Code

1100

Country

Philippines

Facility Name

Local Institution

City

Quezon City

ZIP/Postal Code

1102

Country

Philippines

Facility Name

Local Institution

City

Quezon City

ZIP/Postal Code

1110

Country

Philippines

Facility Name

Local Institution

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

Local Institution

City

Krakow

ZIP/Postal Code

31-202

Country

Poland

Facility Name

Local Institution

City

Lodz

ZIP/Postal Code

91-347

Country

Poland

Facility Name

Local Institution

City

Nowa Sol

ZIP/Postal Code

67-100

Country

Poland

Facility Name

Local Institution

City

Poznan

ZIP/Postal Code

61-833

Country

Poland

Facility Name

Local Institution

City

Skierniewice

ZIP/Postal Code

96-100

Country

Poland

Facility Name

Local Institution

City

Warszawa

ZIP/Postal Code

01-138

Country

Poland

Facility Name

Local Institution

City

Warszawa

ZIP/Postal Code

03-737

Country

Poland

Facility Name

Local Institution

City

Wejherowo

ZIP/Postal Code

84-200

Country

Poland

Facility Name

Local Institution

City

Zielona Gora

ZIP/Postal Code

65-046

Country

Poland

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

111539

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

115280

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

117292

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

117593

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

119991

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

121309

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

127018

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

129336

Country

Russian Federation

Facility Name

Local Institution

City

Odintsovo

ZIP/Postal Code

143000

Country

Russian Federation

Facility Name

Local Institution

City

Podolsk

ZIP/Postal Code

142100

Country

Russian Federation

Facility Name

Local Institution

City

Ryazan

ZIP/Postal Code

390005

Country

Russian Federation

Facility Name

Local Institution

City

Saint Petersburg

ZIP/Postal Code

199106

Country

Russian Federation

Facility Name

Local Institution

City

Saint-Petersburg

ZIP/Postal Code

198205

Country

Russian Federation

Facility Name

Local Institution

City

Saratov

ZIP/Postal Code

410002

Country

Russian Federation

Facility Name

Local Institution

City

Saratov

ZIP/Postal Code

410054

Country

Russian Federation

Facility Name

Local Institution

City

St Petersburg

ZIP/Postal Code

195067

Country

Russian Federation

Facility Name

Local Institution

City

St. Petersburg

ZIP/Postal Code

193312

Country

Russian Federation

Facility Name

Local Institution

City

St.Petersburg

ZIP/Postal Code

192242

Country

Russian Federation

Facility Name

Local Institution

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

Facility Name

Local Institution

City

Singapore

ZIP/Postal Code

529889

Country

Singapore

Facility Name

Local Institution

City

Bloemfontein

State/Province

Free State

ZIP/Postal Code

9301

Country

South Africa

Facility Name

Local Institution

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Local Institution

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0044

Country

South Africa

Facility Name

Local Institution

City

Amanzimtoti

State/Province

Kwa Zulu Natal

ZIP/Postal Code

4120

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

Groenkloof

ZIP/Postal Code

0181

Country

South Africa

Facility Name

Local Institution

City

Torrevieja

State/Province

Alicante

ZIP/Postal Code

03186

Country

Spain

Facility Name

Local Institution

City

Alcorcon(Madrid)

ZIP/Postal Code

28922

Country

Spain

Facility Name

Local Institution

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Local Institution

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Local Institution

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Local Institution

City

Tarragona

ZIP/Postal Code

43007

Country

Spain

Facility Name

Local Institution

City

Goteborg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Local Institution

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

Facility Name

Local Institution

City

Yung-Kang City

State/Province

Tainan

ZIP/Postal Code

710

Country

Taiwan

Facility Name

Local Institution

City

Taichung

ZIP/Postal Code

402

Country

Taiwan

Facility Name

Local Institution

City

Istanbul

State/Province

Capa

ZIP/Postal Code

34390

Country

Turkey

Facility Name

Local Institution

City

Ankara

State/Province

Dikimevi

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Local Institution

City

Istanbul

ZIP/Postal Code

34390

Country

Turkey

Facility Name

Local Institution

City

Donetsk

ZIP/Postal Code

83003

Country

Ukraine

Facility Name

Local Institution

City

Kharkiv

ZIP/Postal Code

61018

Country

Ukraine

Facility Name

Local Institution

City

Kharkiv

ZIP/Postal Code

61176

Country

Ukraine

Facility Name

Local Institution

City

Kharkov

ZIP/Postal Code

61039

Country

Ukraine

Facility Name

Local Institution

City

Kyiv

ZIP/Postal Code

01133

Country

Ukraine

Facility Name

Local Institution

City

Kyiv

ZIP/Postal Code

02091

Country

Ukraine

Facility Name

Local Institution

City

Kyiv

ZIP/Postal Code

03115

Country

Ukraine

Facility Name

Local Institution

City

Kyiv

ZIP/Postal Code

03151

Country

Ukraine

Facility Name

Local Institution

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Local Institution

City

Kyiv

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

Local Institution

City

Kyiv

ZIP/Postal Code

04201

Country

Ukraine

Facility Name

Local Institution

City

Lutsk

ZIP/Postal Code

43024

Country

Ukraine

Facility Name

Local Institution

City

Lviv

ZIP/Postal Code

79010

Country

Ukraine

Facility Name

Local Institution

City

Uzhgorod

ZIP/Postal Code

88000

Country

Ukraine

Facility Name

Local Institution

City

Vinnitsa

ZIP/Postal Code

21029

Country

Ukraine

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

SW3 6LR

Country

United Kingdom

Facility Name

Local Institution

City

Uxbridge

State/Province

Middlesex

ZIP/Postal Code

UB8 3NN

Country

United Kingdom

Facility Name

Local Institution

City

Newcastle

State/Province

Tyne And Wear

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

Local Institution

City

Dudley

State/Province

West Midlands

ZIP/Postal Code

DY1 2HQ

Country

United Kingdom

Facility Name

Local Institution

City

Hull

State/Province

Yorkshire

ZIP/Postal Code

HU3 2JZ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

28762617

Citation

Chi G, Goldhaber SZ, Kittelson JM, Turpie AGG, Hernandez AF, Hull RD, Gold A, Curnutte JT, Cohen AT, Harrington RA, Gibson CM. Effect of extended-duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis. J Thromb Haemost. 2017 Oct;15(10):1913-1922. doi: 10.1111/jth.13783. Epub 2017 Sep 4.

Results Reference

derived

PubMed Identifier

28617144

Citation

Marszalek J, Mehrsefat S, Chi G. The risk of stroke among acutely ill hospitalized medical patients: lessons from recent trials on extended-duration thromboprophylaxis. Expert Rev Hematol. 2017 Aug;10(8):679-684. doi: 10.1080/17474086.2017.1343662. Epub 2017 Jun 21.

Results Reference

derived

PubMed Identifier

22863355

Citation

Sharma A, Chatterjee S, Lichstein E, Mukherjee D. Extended thromboprophylaxis for medically ill patients with decreased mobility: does it improve outcomes? J Thromb Haemost. 2012 Oct;10(10):2053-60. doi: 10.1111/j.1538-7836.2012.04874.x.

Results Reference

derived

PubMed Identifier

22077144

Citation

Goldhaber SZ, Leizorovicz A, Kakkar AK, Haas SK, Merli G, Knabb RM, Weitz JI; ADOPT Trial Investigators. Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. N Engl J Med. 2011 Dec 8;365(23):2167-77. doi: 10.1056/NEJMoa1110899. Epub 2011 Nov 13.

Results Reference

derived

Learn more about this trial

Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness

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Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness (ADOPT)

Venous Thrombosis, Pulmonary Embolism

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial