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Study Of The Blood Thinner, Apixaban, For Patients Who Have An Abnormal Heart Rhythm (Atrial Fibrillation) And Expected To Have Treatment To Put Them Back Into A Normal Heart Rhythm (Cardioversion) (EMANATE)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Apixaban
Parenteral heparin and/or oral Vitamin K antagonist
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Atrial Fibrillation focused on measuring apixaban, oral anticoagulant, non-valvular atrial fibrillation, cardioversion

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects with non-valvular atrial fibrillation (as documented by electrocardiogram (ECG) at Visit 1) indicated for cardioversion and initiation of anticoagulation in accordance with the approved local label. Subjects presenting with atrial flutter with no evidence of atrial fibrillation are not eligible for enrolment.
  • Age ≥18 years (Age ≥ 19 years for Korea only and Age ≥ 20 years for Japan only).
  • Evidence of a personally signed and dated informed consent document indicating that the subject (or their legally-recognized representative) has been informed of all pertinent aspects of the study.
  • The subject is willing to provide contact details for at least one alternate person for study staff to contact regarding their whereabouts, should the subject be lost-to-follow-up over the course of the study. (Subject to IRB/IEC approval)
  • Female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children and is sexually active.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.

Exclusion Criteria:

  • Subjects having taken more than 48 hours of an anticoagulant (oral and/or parenteral) immediately prior to randomization.
  • Contraindications to apixaban or usual care (eg, VKA) in accordance with the approved local label.
  • Severe haemodynamically compromised subjects requiring emergent cardioversion.
  • Patients with hemodynamically significant mitral stenosis, mechanical or biological prosthetic valve or valve repair.
  • Conditions other than atrial fibrillation that require chronic anticoagulation (eg, a prosthetic heart valve).
  • Simultaneous treatment with both aspirin and a thienopyridine (eg, clopidogrel, ticlopidine, prasugrel) or simultaneous treatment with both aspirin and ticagrelor.
  • Pregnant females; breastfeeding females; females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after last dose of investigational product.
  • Participation in other studies involving investigational drug(s) (Phases 1-4) within 30 days before the current study begins and/or during study participation. Note: Subjects cannot be randomized into this study more than once.
  • Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or subjects who are BMS/Pfizer employees directly involved in the conduct of the trial.

Sites / Locations

  • Brookwood Medical Center
  • Cardiovascular Associates of the Southeast, LLC
  • Integrated Medical Services, Inc./IMS Cardiology
  • Chula Vista Cardiac Center
  • Hartford Hospital
  • Certified Physician Investigator Research Group LLC
  • Orlando Heart Specialists
  • The University of Chicago Medical Center Investigational Drug Service Pharmacy (office/storage)
  • The University of Chicago Medical Center Investigational Drug Service Pharmacy
  • University of Chicago Medical Center
  • Chicago Medical Research, LLC
  • Franciscan Physician Network-Indiana Heart Physicians
  • Franciscan St. Francis Health
  • UK Good Samaritan Medical Office Building
  • Good Samaritan Hospital
  • University of Kentucky Medical Center Gill Heart Institute
  • University of Kentucky Gill Heart Institute
  • University of Kentucky HealthCare/Albert. B, Chandler Hospital
  • Aim Clinic
  • Cardiology Outpatient Clinic
  • University of Louisville Clinical Trials Unit
  • University of Louisville Hospital
  • Robley Rex VA Medical Center
  • Alexandria Cardiology Clinic
  • University of Massachusetts Worcester Research Pharmacy
  • University of Massachusetts Worcester
  • William Beaumont Hospital
  • Abbott Northwestern Hopsital - Allina Health System
  • Minneapolis Heart Institute Foundation
  • University of Missouri Health Care System
  • University of Missouri Health System, Investigational Drug Serivce
  • University of Missouri Health System
  • Saint Luke's Lipid and Diabetes Research Center
  • Mercy Hospital St. Louis
  • Electrophysiology Associates
  • Hackensack University Medical Center
  • Robert Wood Johnson University Hospital
  • Rutgers Robert Wood Johnson Medical School Cardiovascular Institute
  • State University of New York (SUNY) Downstate Medical Center
  • New York-Presbyterian/Queens
  • Columbia University Medical Center/NY Presbyterian Hospital
  • University of Cincinnati Medical Center
  • ProMedica Physicians Cardiology
  • ProMedica Toledo Hospital
  • ProMedica Physicians Cardiology
  • Hillcrest Medical Center Pharmacy
  • Oklahoma Heart Institute at Hillcrest Medical Center
  • Oklahoma Heart Institute
  • Cardiology Consultants of Philadelphia
  • Bryn Mawr Hospital
  • Bryn Mawr Medical Specialist Association
  • Penn State Hershey Medical Center
  • Pennsylvania Hospital
  • Einstein Healthcare Network
  • Cardiology consultants of Philadelphia
  • Baptist Hospital of Southeast Texas - Beaumont
  • Southeast Texas Cardiology Associates II, L.L.P.
  • Southeast Texas Cardiology Associates II, L.L.P
  • Southeast Texas Clinical Research Center
  • Utah Cardiology, PC
  • Cardiovascular Associates of Virginia-Bon Secours St. Mary's Hospital
  • St. Francis Medical Center
  • Dominion Cardiovascular Specialists PLLC
  • Sint-Franciskusziekenhuis
  • University Hospital Ghent
  • UZ Leuven
  • Algemeen Ziekenhuis Klina
  • Grand Hopital de Charleroi asbl
  • Jessa Ziekenhuis-Campus Virga Jesse
  • AZ Delta
  • Cliniques Universitatires UCL Mont-Godinne
  • Southlake Regional Health Centre
  • Institut de Cardiologie de Montreal -ICM / Montreal Heart Institute-MHI
  • McGill University Health Center
  • Regionshospitalet Silkeborg
  • Slagelse Hospital
  • Sydvestjysk Sygehus Esbjerg
  • Regionhospitalet Viborg
  • Cardio Centrum Ludwigsburg Bietigheim
  • Charitè Campus Mitte/ Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie
  • Vivantes -Netzwerk fuer Gesundheit GmbH - Klinikum Neukoelln
  • Charité - Campus Virchow-Klinikum
  • Vivantes Netzwerk fuer Gesundhelt GmbH, Humboldt Klinikum
  • Klinikum Links der Weser gGmbH
  • Medizinisches Versorgungszentrum am Küchwald GmbH
  • Klinikum Coburg gGmbH
  • Zentrum fuer klinische Pruefungen in der Facharztzentrum Dresden-Neustadt GbR
  • Praxisklinik Herz und Gefäße
  • Johanniter-Krankenhaus Rheinhausen GmbH/ Klinik fuer Kardiologie
  • Krankenhaus Nordwest GmbH
  • Johann-Wolfgang Goethe-Universitaet
  • Universitatsmedizin Greifswald
  • Universitätsklinikum Hamburg Eppendorf, Universitäres Herzzentrum Hamburg GmbH
  • Unklinik Heidelberg
  • Klinikum Heidenheim
  • Klinikum Ingolstadt/ Medizinische Klinik I und IV
  • Cardiocenter Rhythmologie
  • Herzzentrum Leipzig GmbH/ Abteilung für Rhythmologie
  • Katholisches Klinikum Mainz
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Kliniken Maria Hilf GmbH
  • Universitaetsklinikum Tuebingen
  • Prof. Dr. med. Werner Jung,Schwarzwald - Baar Klinikum
  • Josephs-Hospital Warendorf
  • HaEmek Medical Center
  • Barzilai Medical Center (Cardiology)
  • Soroka University Medical Centre, Soroka Medical center
  • Hillel Yaffe Medical Center
  • Rambam Health Care Campus
  • Lady Davis Carmel Medical Center
  • Shaare Zedek Medical Center
  • Hadassah University Hospital - Mount Scopus
  • Galilee Medical Center
  • Rabin Medical Center
  • Kaplan Medical Center
  • ZIV Medical Center
  • Clinical Trial Network Services
  • Tel Aviv Sourasky Medical Center
  • The Baruch Padeh Medical Center
  • Ospedale Generale Regionale F. Miulli-Ente Ecclesiastico
  • Policlinico Universitario Campus Biomedico
  • I.R.C.C.S. Ospedale San Raffaele S.r.l.
  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
  • Presidio Ospedaliero San Donato
  • Azienda Ospedaliero Universitaria Careggi, Medicina e Cardiologia Geriatrica
  • Centro Cardiologico Monzino
  • DAI Malattie Cardiovascolari e Respiratorie
  • Tosei General Hospital
  • Toho University Ohashi Medical Center
  • Osaka General Medical Center
  • Nippon Medical School Hospital
  • Dong-A Unversity Hospital
  • Keimyung University Dongsan Medical Center
  • Yeungnam University Hospital
  • Chonnam National University Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Samsung Medical Center
  • Korea University Anam Hospital, cardiology and Electrophysiology
  • The Catholic University of Korea Seoul ST.MARY'S Hospital
  • Asan Medical Center
  • Korea University Guro Hospital
  • Ajou University Hospital, Division of Cardiology
  • Brasov Emergency Clinical County Hospital
  • "Prof. Dr.C.C. lliescu" Emergency Institute for Cardiovascular Diseases Bucharest
  • Bucharest Emergency University Hospital
  • Cluj-Napoca Rehabilitation Clinical Hospital
  • Craiova Emergency Clinical County Hospital
  • Prof.Dr.George I.M. Georgescu Cardiovascular Diseases Institute
  • Cardio Med SRL
  • Tirgu Mures Emergency Clinical County Hospital
  • Hospital Universitario San Juan de Alicante
  • Hospital de Sierrallana
  • Consorci Sanitari de Terrassa Hospital de Terrassa
  • Hospital Universitario Infanta Sofía
  • Hospital de Basurto
  • Hospital General Universitario Gregorio Maranon
  • Fundacion Jimenez Diaz
  • Danderyds Sjukhus AB
  • Akademiska Sjukhuset I Uppsala/ Kardiologikliniken
  • Sahlgrenska University Hospital
  • Linkopings Universitetssjukhus Kardiologkliniken
  • Universitetssjukhuset i Orebro/ Hjartmottagningen
  • Skelleftea Country Hospital
  • Sodersjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Apixaban

Parenteral heparin and/or oral Vitamin K antagonist

Arm Description

Parenteral heparin and/or locally used oral Vitamin K antagonist e.g. warfarin (excludes other novel oral anticoagulants)

Outcomes

Primary Outcome Measures

Number of Participants With Acute Stroke Event
An acute stroke was defined as a new, important neurological insufficiency of rapid onset that lasted for at least 24 hours and that was not due to a readily identifiable non-vascular cause (like brain tumor or trauma).
Number of Participants With Systemic Embolism Event
Systemic embolism occurred in participant when there was a clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), which was supported by evidence of embolism from surgical specimens, autopsy, angiography, or other objective testing.
Number of Participants With Major Bleeding Event
Major bleeding was defined as clinically evident bleeding that was accompanied by one or more of the following: a decrease in hemoglobin of 2 gram per deciliter or more, a transfusion of 2 or more units of packed red blood cells, bleeding that was fatal or bleeding that occurred in at least one of the following critical sites: intracranial, intra-spinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed was not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal.
Number of Participants With Clinically Relevant Non-Major Bleeding Events
Clinically relevant non-major bleeding was defined as the clinically evident bleeding that consisted of any bleeding that compromised hemodynamics, that led to hospitalization, subcutaneous hematoma larger than 25/100 centimeter square if there was a traumatic cause, intramuscular hematoma documented by ultrasonography, epistaxis, gingival bleeding occurred spontaneously, hematuria that was macroscopic and was spontaneous, macroscopic gastrointestinal hemorrhage included at least one episode of melena or hematemesis, rectal blood loss, hemoptysis or any other bleeding type considered to have clinical consequences for a participant, such as medical intervention, the need for unscheduled contact with a physician, or temporary cessation of a study drug, or associated with pain or impairment of activities of daily life.
Number of Participants With All Cause Death

Secondary Outcome Measures

Time to First Attempt of Cardioversion
Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using electricity or drugs. First attempt of cardioversion was defined as the first time the participant was admitted for the cardioversion procedure.
Number of Participants With Different Type of Cardioversion Events
Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using different type of cardioversion events i.e. electrical and pharmacologic. Electrical cardioversion was a procedure in which an electric current was used to reset the heart's rhythm back to its regular pattern (normal sinus rhythm). Pharmacologic cardioversion, also called chemical cardioversion, used antiarrhythmia medication instead of an electrical shock.
Number of Cardioversion Attempt of Participants
Cardioversion attempts were defined as the number of times the participant was admitted to hospital for the cardioversion procedure and not the number of attempts during a single hospital admission.
Number of Participants With Their Rhythm Status
Rhythm status was further distinguished into sinus rhythm, atrial fibrillation and atrial flutter. Sinus rhythm was defined as a normal heartbeat. Atrial fibrillation was an irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications and atrial flutter was a common abnormal heart rhythm that was usually associated with a fast heart rate (100 or more heart beats per minute).
Duration of Hospital Stay of Participants
Duration of hospital stay was defined as the number of hours from hospital admission to hospital discharge followed by early cardioversion.
Number of Participants Who Used Image Guidance Approach
An image-guided approach helped cardioversion earlier than the conventional minimum of 3 weeks of anticoagulation that would normally be required prior to cardioversion. Transesophageal echocardiography (TEE or TOE) and computed tomography (CT) were 2 image-guided approaches that were used in this study.

Full Information

First Posted
February 5, 2014
Last Updated
May 21, 2018
Sponsor
Pfizer
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02100228
Brief Title
Study Of The Blood Thinner, Apixaban, For Patients Who Have An Abnormal Heart Rhythm (Atrial Fibrillation) And Expected To Have Treatment To Put Them Back Into A Normal Heart Rhythm (Cardioversion)
Acronym
EMANATE
Official Title
A Phase Iv Trial To Assess The Effectiveness Of Apixaban Compared With Usual Care Anticoagulation In Subjects With Non-valvular Atrial Fibrillation Undergoing Cardioversion
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 14, 2014 (Actual)
Primary Completion Date
February 8, 2017 (Actual)
Study Completion Date
February 8, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Some people can develop an abnormal heart beat known as "Atrial fibrillation" or "AF" that puts them at risk of developing clots in the heart. Those clots can travel in the blood circulation to the brain and cause a brain attack ("a stroke"). To prevent those clots forming, blood thinners (anti-coagulants) are used. Apixaban is a blood thinner that works by stopping one of the blood substances required for clotting ("Factor Xa"). It is approved and used to prevent clots forming in people with "AF". Other established blood thinners work by stopping clotting substances being made, known as "Vitamin K antagonists" or "VKAs". An example of this type is Warfarin (Coumadin). The good effects of all blood thinners are preventing clots, and they may also have bad effects of increasing the chance of bleeding. People with "AF", abnormal heart beat, may benefit from changing it back to a normal regular rhythm, known medically as "cardioversion". When this is done, people are currently most commonly treated with a "VKA" blood thinner (e.g. warfarin). The purpose of this study is to assess the good and bad effects ("efficacy" and "safety") of apixaban compared with warfarin in people with "AF" in whom an early cardioversion is planned.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
apixaban, oral anticoagulant, non-valvular atrial fibrillation, cardioversion

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apixaban
Arm Type
Experimental
Arm Title
Parenteral heparin and/or oral Vitamin K antagonist
Arm Type
Active Comparator
Arm Description
Parenteral heparin and/or locally used oral Vitamin K antagonist e.g. warfarin (excludes other novel oral anticoagulants)
Intervention Type
Drug
Intervention Name(s)
Apixaban
Intervention Description
Oral, 2.5 or 5 mg BID
Intervention Type
Drug
Intervention Name(s)
Parenteral heparin and/or oral Vitamin K antagonist
Intervention Description
Parenteral heparin and/or locally used oral Vitamin K antagonist e.g. warfarin (excludes other novel oral anticoagulants)
Primary Outcome Measure Information:
Title
Number of Participants With Acute Stroke Event
Description
An acute stroke was defined as a new, important neurological insufficiency of rapid onset that lasted for at least 24 hours and that was not due to a readily identifiable non-vascular cause (like brain tumor or trauma).
Time Frame
Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
Title
Number of Participants With Systemic Embolism Event
Description
Systemic embolism occurred in participant when there was a clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), which was supported by evidence of embolism from surgical specimens, autopsy, angiography, or other objective testing.
Time Frame
Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
Title
Number of Participants With Major Bleeding Event
Description
Major bleeding was defined as clinically evident bleeding that was accompanied by one or more of the following: a decrease in hemoglobin of 2 gram per deciliter or more, a transfusion of 2 or more units of packed red blood cells, bleeding that was fatal or bleeding that occurred in at least one of the following critical sites: intracranial, intra-spinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed was not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal.
Time Frame
Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
Title
Number of Participants With Clinically Relevant Non-Major Bleeding Events
Description
Clinically relevant non-major bleeding was defined as the clinically evident bleeding that consisted of any bleeding that compromised hemodynamics, that led to hospitalization, subcutaneous hematoma larger than 25/100 centimeter square if there was a traumatic cause, intramuscular hematoma documented by ultrasonography, epistaxis, gingival bleeding occurred spontaneously, hematuria that was macroscopic and was spontaneous, macroscopic gastrointestinal hemorrhage included at least one episode of melena or hematemesis, rectal blood loss, hemoptysis or any other bleeding type considered to have clinical consequences for a participant, such as medical intervention, the need for unscheduled contact with a physician, or temporary cessation of a study drug, or associated with pain or impairment of activities of daily life.
Time Frame
Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
Title
Number of Participants With All Cause Death
Time Frame
Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
Secondary Outcome Measure Information:
Title
Time to First Attempt of Cardioversion
Description
Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using electricity or drugs. First attempt of cardioversion was defined as the first time the participant was admitted for the cardioversion procedure.
Time Frame
Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
Title
Number of Participants With Different Type of Cardioversion Events
Description
Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using different type of cardioversion events i.e. electrical and pharmacologic. Electrical cardioversion was a procedure in which an electric current was used to reset the heart's rhythm back to its regular pattern (normal sinus rhythm). Pharmacologic cardioversion, also called chemical cardioversion, used antiarrhythmia medication instead of an electrical shock.
Time Frame
Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
Title
Number of Cardioversion Attempt of Participants
Description
Cardioversion attempts were defined as the number of times the participant was admitted to hospital for the cardioversion procedure and not the number of attempts during a single hospital admission.
Time Frame
Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
Title
Number of Participants With Their Rhythm Status
Description
Rhythm status was further distinguished into sinus rhythm, atrial fibrillation and atrial flutter. Sinus rhythm was defined as a normal heartbeat. Atrial fibrillation was an irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications and atrial flutter was a common abnormal heart rhythm that was usually associated with a fast heart rate (100 or more heart beats per minute).
Time Frame
Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
Title
Duration of Hospital Stay of Participants
Description
Duration of hospital stay was defined as the number of hours from hospital admission to hospital discharge followed by early cardioversion.
Time Frame
Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
Title
Number of Participants Who Used Image Guidance Approach
Description
An image-guided approach helped cardioversion earlier than the conventional minimum of 3 weeks of anticoagulation that would normally be required prior to cardioversion. Transesophageal echocardiography (TEE or TOE) and computed tomography (CT) were 2 image-guided approaches that were used in this study.
Time Frame
Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with non-valvular atrial fibrillation (as documented by electrocardiogram (ECG) at Visit 1) indicated for cardioversion and initiation of anticoagulation in accordance with the approved local label. Subjects presenting with atrial flutter with no evidence of atrial fibrillation are not eligible for enrolment. Age ≥18 years (Age ≥ 19 years for Korea only and Age ≥ 20 years for Japan only). Evidence of a personally signed and dated informed consent document indicating that the subject (or their legally-recognized representative) has been informed of all pertinent aspects of the study. The subject is willing to provide contact details for at least one alternate person for study staff to contact regarding their whereabouts, should the subject be lost-to-follow-up over the course of the study. (Subject to IRB/IEC approval) Female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children and is sexually active. Subjects who are willing and able to comply with scheduled visits, treatment plan, and other study procedures. Exclusion Criteria: Subjects having taken more than 48 hours of an anticoagulant (oral and/or parenteral) immediately prior to randomization. Contraindications to apixaban or usual care (eg, VKA) in accordance with the approved local label. Severe haemodynamically compromised subjects requiring emergent cardioversion. Patients with hemodynamically significant mitral stenosis, mechanical or biological prosthetic valve or valve repair. Conditions other than atrial fibrillation that require chronic anticoagulation (eg, a prosthetic heart valve). Simultaneous treatment with both aspirin and a thienopyridine (eg, clopidogrel, ticlopidine, prasugrel) or simultaneous treatment with both aspirin and ticagrelor. Pregnant females; breastfeeding females; females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after last dose of investigational product. Participation in other studies involving investigational drug(s) (Phases 1-4) within 30 days before the current study begins and/or during study participation. Note: Subjects cannot be randomized into this study more than once. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or subjects who are BMS/Pfizer employees directly involved in the conduct of the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Brookwood Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Cardiovascular Associates of the Southeast, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Integrated Medical Services, Inc./IMS Cardiology
City
Avondale
State/Province
Arizona
ZIP/Postal Code
85392
Country
United States
Facility Name
Chula Vista Cardiac Center
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Certified Physician Investigator Research Group LLC
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32714
Country
United States
Facility Name
Orlando Heart Specialists
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32714
Country
United States
Facility Name
The University of Chicago Medical Center Investigational Drug Service Pharmacy (office/storage)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
The University of Chicago Medical Center Investigational Drug Service Pharmacy
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Chicago Medical Research, LLC
City
Hazel Crest
State/Province
Illinois
ZIP/Postal Code
60429
Country
United States
Facility Name
Franciscan Physician Network-Indiana Heart Physicians
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Franciscan St. Francis Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
UK Good Samaritan Medical Office Building
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40508-2678
Country
United States
Facility Name
Good Samaritan Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40508-3008
Country
United States
Facility Name
University of Kentucky Medical Center Gill Heart Institute
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0200
Country
United States
Facility Name
University of Kentucky Gill Heart Institute
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Kentucky HealthCare/Albert. B, Chandler Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Aim Clinic
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Cardiology Outpatient Clinic
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville Clinical Trials Unit
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Robley Rex VA Medical Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Alexandria Cardiology Clinic
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
University of Massachusetts Worcester Research Pharmacy
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Massachusetts Worcester
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Abbott Northwestern Hopsital - Allina Health System
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
University of Missouri Health Care System
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
University of Missouri Health System, Investigational Drug Serivce
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
University of Missouri Health System
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Saint Luke's Lipid and Diabetes Research Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Mercy Hospital St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Electrophysiology Associates
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Rutgers Robert Wood Johnson Medical School Cardiovascular Institute
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
State University of New York (SUNY) Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
New York-Presbyterian/Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Columbia University Medical Center/NY Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
ProMedica Physicians Cardiology
City
Oregon
State/Province
Ohio
ZIP/Postal Code
43616
Country
United States
Facility Name
ProMedica Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
ProMedica Physicians Cardiology
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43615
Country
United States
Facility Name
Hillcrest Medical Center Pharmacy
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Oklahoma Heart Institute at Hillcrest Medical Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Oklahoma Heart Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Cardiology Consultants of Philadelphia
City
Bristol
State/Province
Pennsylvania
ZIP/Postal Code
19007
Country
United States
Facility Name
Bryn Mawr Hospital
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Bryn Mawr Medical Specialist Association
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Einstein Healthcare Network
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Cardiology consultants of Philadelphia
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
Baptist Hospital of Southeast Texas - Beaumont
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Southeast Texas Cardiology Associates II, L.L.P.
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Southeast Texas Cardiology Associates II, L.L.P
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Southeast Texas Clinical Research Center
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Utah Cardiology, PC
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Cardiovascular Associates of Virginia-Bon Secours St. Mary's Hospital
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Facility Name
St. Francis Medical Center
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Facility Name
Dominion Cardiovascular Specialists PLLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Sint-Franciskusziekenhuis
City
Heusden-Zolder
State/Province
Limburg
ZIP/Postal Code
3550
Country
Belgium
Facility Name
University Hospital Ghent
City
Gent
State/Province
Oost-vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Algemeen Ziekenhuis Klina
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Facility Name
Grand Hopital de Charleroi asbl
City
Gilly
ZIP/Postal Code
6060
Country
Belgium
Facility Name
Jessa Ziekenhuis-Campus Virga Jesse
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Cliniques Universitatires UCL Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
Institut de Cardiologie de Montreal -ICM / Montreal Heart Institute-MHI
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Regionshospitalet Silkeborg
City
Silkeborg
State/Province
Midtjylland
ZIP/Postal Code
DK-8600
Country
Denmark
Facility Name
Slagelse Hospital
City
Slagelse
State/Province
Sjaelland
ZIP/Postal Code
DK-4200
Country
Denmark
Facility Name
Sydvestjysk Sygehus Esbjerg
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Regionhospitalet Viborg
City
Viborg
ZIP/Postal Code
DK-8800
Country
Denmark
Facility Name
Cardio Centrum Ludwigsburg Bietigheim
City
Ludwigsburg
State/Province
Baden-württemberg
ZIP/Postal Code
71634
Country
Germany
Facility Name
Charitè Campus Mitte/ Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Vivantes -Netzwerk fuer Gesundheit GmbH - Klinikum Neukoelln
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Facility Name
Charité - Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Vivantes Netzwerk fuer Gesundhelt GmbH, Humboldt Klinikum
City
Berlin
ZIP/Postal Code
13509
Country
Germany
Facility Name
Klinikum Links der Weser gGmbH
City
Bremen
ZIP/Postal Code
28277
Country
Germany
Facility Name
Medizinisches Versorgungszentrum am Küchwald GmbH
City
Chemnitz
ZIP/Postal Code
09113
Country
Germany
Facility Name
Klinikum Coburg gGmbH
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Zentrum fuer klinische Pruefungen in der Facharztzentrum Dresden-Neustadt GbR
City
Dresden
ZIP/Postal Code
01099
Country
Germany
Facility Name
Praxisklinik Herz und Gefäße
City
Dresden
ZIP/Postal Code
01324
Country
Germany
Facility Name
Johanniter-Krankenhaus Rheinhausen GmbH/ Klinik fuer Kardiologie
City
Duisburg
ZIP/Postal Code
47228
Country
Germany
Facility Name
Krankenhaus Nordwest GmbH
City
Frankfurt am Main
ZIP/Postal Code
60488
Country
Germany
Facility Name
Johann-Wolfgang Goethe-Universitaet
City
Frankfurt/Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitatsmedizin Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Universitätsklinikum Hamburg Eppendorf, Universitäres Herzzentrum Hamburg GmbH
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Unklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Klinikum Heidenheim
City
Heidenheim
ZIP/Postal Code
89522
Country
Germany
Facility Name
Klinikum Ingolstadt/ Medizinische Klinik I und IV
City
Ingolstadt
ZIP/Postal Code
85049
Country
Germany
Facility Name
Cardiocenter Rhythmologie
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Herzzentrum Leipzig GmbH/ Abteilung für Rhythmologie
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Katholisches Klinikum Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Kliniken Maria Hilf GmbH
City
Moenchengladbach
ZIP/Postal Code
41063
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Prof. Dr. med. Werner Jung,Schwarzwald - Baar Klinikum
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
Facility Name
Josephs-Hospital Warendorf
City
Warendorf
ZIP/Postal Code
48231
Country
Germany
Facility Name
HaEmek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Barzilai Medical Center (Cardiology)
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Soroka University Medical Centre, Soroka Medical center
City
Be'er Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Lady Davis Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Hadassah University Hospital - Mount Scopus
City
Jerusalem
ZIP/Postal Code
91240
Country
Israel
Facility Name
Galilee Medical Center
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
ZIV Medical Center
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Clinical Trial Network Services
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
The Baruch Padeh Medical Center
City
Tiberias
ZIP/Postal Code
1528001
Country
Israel
Facility Name
Ospedale Generale Regionale F. Miulli-Ente Ecclesiastico
City
Acquaviva Delle Fonti (BA)
State/Province
Bari
ZIP/Postal Code
70021
Country
Italy
Facility Name
Policlinico Universitario Campus Biomedico
City
Roma
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Facility Name
I.R.C.C.S. Ospedale San Raffaele S.r.l.
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
City
Torrette Di Ancona
State/Province
Marche
ZIP/Postal Code
60020
Country
Italy
Facility Name
Presidio Ospedaliero San Donato
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Careggi, Medicina e Cardiologia Geriatrica
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Centro Cardiologico Monzino
City
Milano
ZIP/Postal Code
20138
Country
Italy
Facility Name
DAI Malattie Cardiovascolari e Respiratorie
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Tosei General Hospital
City
Seto
State/Province
Aichi
ZIP/Postal Code
489-8642
Country
Japan
Facility Name
Toho University Ohashi Medical Center
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
153-8515
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Dong-A Unversity Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu-si
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Yeungnam University Hospital
City
Deagu
ZIP/Postal Code
705703
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120752
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital, cardiology and Electrophysiology
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul ST.MARY'S Hospital
City
Seoul
ZIP/Postal Code
137701
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Ajou University Hospital, Division of Cardiology
City
Suwon
ZIP/Postal Code
443-380
Country
Korea, Republic of
Facility Name
Brasov Emergency Clinical County Hospital
City
Brasov
ZIP/Postal Code
500326
Country
Romania
Facility Name
"Prof. Dr.C.C. lliescu" Emergency Institute for Cardiovascular Diseases Bucharest
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Bucharest Emergency University Hospital
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
Cluj-Napoca Rehabilitation Clinical Hospital
City
Cluj-Napoca
ZIP/Postal Code
400347
Country
Romania
Facility Name
Craiova Emergency Clinical County Hospital
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
Prof.Dr.George I.M. Georgescu Cardiovascular Diseases Institute
City
Iasi
ZIP/Postal Code
700503
Country
Romania
Facility Name
Cardio Med SRL
City
Targu Mures
ZIP/Postal Code
540124
Country
Romania
Facility Name
Tirgu Mures Emergency Clinical County Hospital
City
Tirgu Mures
ZIP/Postal Code
540139
Country
Romania
Facility Name
Hospital Universitario San Juan de Alicante
City
San Juan
State/Province
Alicante
ZIP/Postal Code
03550
Country
Spain
Facility Name
Hospital de Sierrallana
City
Torrelavega
State/Province
Cantabria
ZIP/Postal Code
39300
Country
Spain
Facility Name
Consorci Sanitari de Terrassa Hospital de Terrassa
City
Terrassa
State/Province
Cataluna
ZIP/Postal Code
08227
Country
Spain
Facility Name
Hospital Universitario Infanta Sofía
City
San Sebastián De Los Reyes
State/Province
Madrid
ZIP/Postal Code
28702
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Danderyds Sjukhus AB
City
Stockholm
State/Province
Sodermanlands LAN
Country
Sweden
Facility Name
Akademiska Sjukhuset I Uppsala/ Kardiologikliniken
City
Uppsala
State/Province
Uppsala IAN
Country
Sweden
Facility Name
Sahlgrenska University Hospital
City
Göteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Linkopings Universitetssjukhus Kardiologkliniken
City
Linkoping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Universitetssjukhuset i Orebro/ Hjartmottagningen
City
Orebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Skelleftea Country Hospital
City
Skelleftea
ZIP/Postal Code
931 86
Country
Sweden
Facility Name
Sodersjukhuset
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
29659797
Citation
Ezekowitz MD, Pollack CV Jr, Halperin JL, England RD, VanPelt Nguyen S, Spahr J, Sudworth M, Cater NB, Breazna A, Oldgren J, Kirchhof P. Apixaban compared to heparin/vitamin K antagonist in patients with atrial fibrillation scheduled for cardioversion: the EMANATE trial. Eur Heart J. 2018 Aug 21;39(32):2959-2971. doi: 10.1093/eurheartj/ehy148.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0661025&StudyName=A%20Phase%20IV%20Trial%20To%20Assess%20The%20Effectiveness%20Of%20Apixaban%20Compared%20With%20Usual%20Care%20Anticoagulation%20In%20Subjects%20With%20Non-Valvular%20Atrial%20Fibrillation%20Undergoing%20Cardioversion
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Study Of The Blood Thinner, Apixaban, For Patients Who Have An Abnormal Heart Rhythm (Atrial Fibrillation) And Expected To Have Treatment To Put Them Back Into A Normal Heart Rhythm (Cardioversion)

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