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)

A Phase Iv Trial To Assess The Effectiveness Of Apixaban Compared With Usual Care Anticoagulation In Subjects With Non-valvular Atrial Fibrillation Undergoing Cardioversion

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Apixaban; Drug: Parenteral heparin and/or oral Vitamin K antagonist

• Study Type: Interventional
• Enrollment (Actual): 1500
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Brasschaat, Belgium, 2930
    • Algemeen Ziekenhuis Klina
  • Gilly, Belgium, 6060
    • Grand Hopital de Charleroi asbl
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis-Campus Virga Jesse
  • Roeselare, Belgium, 8800
    • AZ Delta
  • Yvoir, Belgium, 5530
    • Cliniques Universitatires UCL Mont-Godinne
  • Limburg
    • Heusden-Zolder, Limburg, Belgium, 3550
      • Sint-Franciskusziekenhuis
  • Oost-vlaanderen
    • Gent, Oost-vlaanderen, Belgium, 9000
      • University Hospital Ghent
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • UZ Leuven
• Canada
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Southlake Regional Health Centre
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • McGill University Health Center
    • Montreal, Quebec, Canada, H1T 1C8
      • Institut de Cardiologie de Montreal -ICM / Montreal Heart Institute-MHI
• Denmark
  • Esbjerg, Denmark, 6700
    • Sydvestjysk Sygehus Esbjerg
  • Viborg, Denmark, DK-8800
    • Regionhospitalet Viborg
  • Midtjylland
    • Silkeborg, Midtjylland, Denmark, DK-8600
      • Regionshospitalet Silkeborg
  • Sjaelland
    • Slagelse, Sjaelland, Denmark, DK-4200
      • Slagelse Hospital
• Germany
  • Berlin, Germany, 13353
    • Charite - Campus Virchow-Klinikum
  • Berlin, Germany, 10117
    • Charitè Campus Mitte/ Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie
  • Berlin, Germany, 12351
    • Vivantes -Netzwerk fuer Gesundheit GmbH - Klinikum Neukoelln
  • Berlin, Germany, 13509
    • Vivantes Netzwerk fuer Gesundhelt GmbH, Humboldt Klinikum
  • Bremen, Germany, 28277
    • Klinikum Links der Weser gGmbH
  • Chemnitz, Germany, 09113
    • Medizinisches Versorgungszentrum am Küchwald GmbH
  • Coburg, Germany, 96450
    • Klinikum Coburg gGmbH
  • Dresden, Germany, 01099
    • Zentrum fuer klinische Pruefungen in der Facharztzentrum Dresden-Neustadt GbR
  • Dresden, Germany, 01324
    • Praxisklinik Herz und Gefäße
  • Duisburg, Germany, 47228
    • Johanniter-Krankenhaus Rheinhausen GmbH/ Klinik fuer Kardiologie
  • Frankfurt am Main, Germany, 60488
    • Krankenhaus Nordwest Gmbh
  • Frankfurt/Main, Germany, 60590
    • Johann-Wolfgang Goethe-Universitaet
  • Greifswald, Germany, 17475
    • Universitätsmedizin Greifswald
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg Eppendorf, Universitäres Herzzentrum Hamburg GmbH
  • Heidelberg, Germany, 69120
    • Unklinik Heidelberg
  • Heidenheim, Germany, 89522
    • Klinikum Heidenheim
  • Ingolstadt, Germany, 85049
    • Klinikum Ingolstadt/ Medizinische Klinik I und IV
  • Leipzig, Germany, 04289
    • Cardiocenter Rhythmologie
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig GmbH/ Abteilung für Rhythmologie
  • Mainz, Germany, 55131
    • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Mainz, Germany, 55131
    • Katholisches Klinikum Mainz
  • Moenchengladbach, Germany, 41063
    • Kliniken Maria Hilf GmbH
  • Tuebingen, Germany, 72076
    • Universitaetsklinikum Tuebingen
  • Villingen-Schwenningen, Germany, 78052
    • Prof. Dr. med. Werner Jung,Schwarzwald - Baar Klinikum
  • Warendorf, Germany, 48231
    • Josephs-Hospital Warendorf
  • Baden-württemberg
    • Ludwigsburg, Baden-württemberg, Germany, 71634
      • Cardio Centrum Ludwigsburg Bietigheim
• Israel
  • Afula, Israel, 18101
    • Haemek Medical Center
  • Ashkelon, Israel, 78278
    • Barzilai Medical Center (Cardiology)
  • Be'er Sheva, Israel, 84101
    • Soroka University Medical Centre, Soroka Medical center
  • Hadera, Israel, 38100
    • Hillel Yaffe Medical Center
  • Haifa, Israel, 31096
    • Rambam Health Care Campus
  • Haifa, Israel, 34362
    • Lady Davis Carmel Medical Center
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center
  • Jerusalem, Israel, 91240
    • Hadassah University Hospital - Mount Scopus
  • Nahariya, Israel, 22100
    • Galilee Medical Center
  • Petach Tikva, Israel, 49100
    • Rabin Medical Center
  • Rehovot, Israel, 76100
    • Kaplan Medical Center
  • Safed, Israel, 13100
    • Ziv Medical Center
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center
  • Tel Aviv, Israel, 64239
    • Clinical Trial Network Services
  • Tiberias, Israel, 1528001
    • The Baruch Padeh Medical Center
• Italy
  • Arezzo, Italy, 52100
    • Presidio Ospedaliero San Donato
  • Firenze, Italy, 50134
    • Azienda Ospedaliero Universitaria Careggi, Medicina e Cardiologia Geriatrica
  • Milano, Italy, 20138
    • Centro Cardiologico Monzino
  • Roma, Italy, 00161
    • DAI Malattie Cardiovascolari e Respiratorie
  • Bari
    • Acquaviva Delle Fonti (BA), Bari, Italy, 70021
      • Ospedale Generale Regionale F. Miulli-Ente Ecclesiastico
  • Lazio
    • Roma, Lazio, Italy, 00128
      • Policlinico Universitario Campus Biomedico
  • Lombardia
    • Milano, Lombardia, Italy, 20132
      • I.R.C.C.S. Ospedale San Raffaele S.r.l.
  • Marche
    • Torrette Di Ancona, Marche, Italy, 60020
      • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
• Japan
  • Osaka, Japan, 558-8558
    • Osaka General Medical Center
  • Tokyo, Japan, 113-8603
    • Nippon Medical School Hospital
  • Aichi
    • Seto, Aichi, Japan, 489-8642
      • Tosei General Hospital
  • Tokyo
    • Meguro-ku, Tokyo, Japan, 153-8515
      • Toho University Ohashi Medical Center
• Korea, Republic of
  • Busan, Korea, Republic of, 49201
    • Dong-A Unversity Hospital
  • Daegu-si, Korea, Republic of, 700-712
    • Keimyung University Dongsan Medical Center
  • Deagu, Korea, Republic of, 705703
    • Yeungnam University Hospital
  • Gwangju, Korea, Republic of, 501-757
    • Chonnam National University Hospital
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 152-703
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 120752
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 136-705
    • Korea University Anam Hospital, cardiology and Electrophysiology
  • Seoul, Korea, Republic of, 137701
    • The Catholic University of Korea Seoul St.Mary's Hospital
  • Suwon, Korea, Republic of, 443-380
    • Ajou University Hospital, Division of Cardiology
• Romania
  • Brasov, Romania, 500326
    • Brasov Emergency Clinical County Hospital
  • Bucharest, Romania, 022328
    • "Prof. Dr.C.C. lliescu" Emergency Institute for Cardiovascular Diseases Bucharest
  • Bucharest, Romania, 050098
    • Bucharest Emergency University Hospital
  • Cluj-Napoca, Romania, 400347
    • Cluj-Napoca Rehabilitation Clinical Hospital
  • Craiova, Romania, 200642
    • Craiova Emergency Clinical County Hospital
  • Iasi, Romania, 700503
    • Prof.Dr.George I.M. Georgescu Cardiovascular Diseases Institute
  • Targu Mures, Romania, 540124
    • Cardio Med SRL
  • Tirgu Mures, Romania, 540139
    • Tirgu Mures Emergency Clinical County Hospital
• Spain
  • Bilbao, Spain, 48013
    • Hospital de Basurto
  • Madrid, Spain, 28040
    • Fundacion Jimenez Diaz
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Alicante
    • San Juan, Alicante, Spain, 03550
      • Hospital Universitario San Juan de Alicante
  • Cantabria
    • Torrelavega, Cantabria, Spain, 39300
      • Hospital de Sierrallana
  • Cataluna
    • Terrassa, Cataluna, Spain, 08227
      • Consorci Sanitari de Terrassa Hospital de Terrassa
  • Madrid
    • San Sebastián De Los Reyes, Madrid, Spain, 28702
      • Hospital Universitario Infanta Sofía
• Sweden
  • Göteborg, Sweden, 41345
    • Sahlgrenska University Hospital
  • Linkoping, Sweden, 581 85
    • Linkopings Universitetssjukhus Kardiologkliniken
  • Orebro, Sweden, 701 85
    • Universitetssjukhuset i Orebro/ Hjartmottagningen
  • Skelleftea, Sweden, 931 86
    • Skelleftea Country Hospital
  • Stockholm, Sweden, 11883
    • Södersjukhuset
  • Sodermanlands LAN
    • Stockholm, Sodermanlands LAN, Sweden
      • Danderyds sjukhus AB
  • Uppsala IAN
    • Uppsala, Uppsala IAN, Sweden
      • Akademiska Sjukhuset I Uppsala/ Kardiologikliniken
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Brookwood Medical Center
    • Birmingham, Alabama, United States, 35243
      • Cardiovascular Associates of the Southeast, LLC
  • Arizona
    • Avondale, Arizona, United States, 85392
      • Integrated Medical Services, Inc./IMS Cardiology
  • California
    • Chula Vista, California, United States, 91910
      • Chula Vista Cardiac Center
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • Florida
    • Altamonte Springs, Florida, United States, 32714
      • Certified Physician Investigator Research Group LLC
    • Altamonte Springs, Florida, United States, 32714
      • Orlando Heart Specialists
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medical Center Investigational Drug Service Pharmacy (office/storage)
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medical Center Investigational Drug Service Pharmacy
    • Hazel Crest, Illinois, United States, 60429
      • Chicago Medical Research, LLC
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Franciscan St. Francis Health
    • Indianapolis, Indiana, United States, 46237
      • Franciscan Physician Network-Indiana Heart Physicians
  • Kentucky
    • Lexington, Kentucky, United States, 40508-2678
      • UK Good Samaritan Medical Office Building
    • Lexington, Kentucky, United States, 40508-3008
      • Good Samaritan Hospital
    • Lexington, Kentucky, United States, 40536-0200
      • University of Kentucky Medical Center Gill Heart Institute
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Gill Heart Institute
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky HealthCare/Albert. B, Chandler Hospital
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Hospital
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Clinical Trials Unit
    • Louisville, Kentucky, United States, 40206
      • Robley Rex VA Medical Center
    • Louisville, Kentucky, United States, 40202
      • Aim Clinic
    • Louisville, Kentucky, United States, 40202
      • Cardiology Outpatient Clinic
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Alexandria Cardiology Clinic
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Worcester
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Worcester Research Pharmacy
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hopsital - Allina Health System
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health System
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health Care System
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health System, Investigational Drug Serivce
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Lipid and Diabetes Research Center
    • Saint Louis, Missouri, United States, 63141
      • Mercy Hospital St. Louis
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • Hackensack, New Jersey, United States, 07601
      • Electrophysiology Associates
    • New Brunswick, New Jersey, United States, 08901
      • Robert Wood Johnson University Hospital
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Robert Wood Johnson Medical School Cardiovascular Institute
  • New York
    • Brooklyn, New York, United States, 11203
      • State University of New York (SUNY) Downstate Medical Center
    • Flushing, New York, United States, 11355
      • New York-Presbyterian/Queens
    • New York, New York, United States, 10032
      • Columbia University Medical Center/NY Presbyterian Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Medical Center
    • Oregon, Ohio, United States, 43616
      • ProMedica Physicians Cardiology
    • Toledo, Ohio, United States, 43606
      • ProMedica Toledo Hospital
    • Toledo, Ohio, United States, 43615
      • ProMedica Physicians Cardiology
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Heart Institute
    • Tulsa, Oklahoma, United States, 74104
      • Hillcrest Medical Center Pharmacy
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Heart Institute at Hillcrest Medical Center
  • Pennsylvania
    • Bristol, Pennsylvania, United States, 19007
      • Cardiology Consultants of Philadelphia
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Bryn Mawr Hospital
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Bryn Mawr Medical Specialist Association
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Pennsylvania Hospital
    • Philadelphia, Pennsylvania, United States, 19141
      • Einstein Healthcare Network
    • Yardley, Pennsylvania, United States, 19067
      • Cardiology Consultants of Philadelphia
  • Texas
    • Beaumont, Texas, United States, 77702
      • Southeast Texas Clinical Research Center
    • Beaumont, Texas, United States, 77702
      • Southeast Texas Cardiology Associates II, L.L.P.
    • Beaumont, Texas, United States, 77701
      • Baptist Hospital of Southeast Texas - Beaumont
    • Beaumont, Texas, United States, 77702
      • Southeast Texas Cardiology Associates II, L.L.P
  • Utah
    • Layton, Utah, United States, 84041
      • Utah Cardiology, PC
  • Virginia
    • Midlothian, Virginia, United States, 23114
      • Cardiovascular Associates of Virginia-Bon Secours St. Mary's Hospital
    • Midlothian, Virginia, United States, 23114
      • St. Francis Medical Center
    • Richmond, Virginia, United States, 23225
      • Dominion Cardiovascular Specialists PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apixaban	Drug: Apixaban; Oral, 2.5 or 5 mg BID
Active Comparator: Parenteral heparin and/or oral Vitamin K antagonist; Parenteral heparin and/or locally used oral Vitamin K antagonist e.g. warfarin (excludes other novel oral anticoagulants)	Drug: Parenteral heparin and/or oral Vitamin K antagonist; Parenteral heparin and/or locally used oral Vitamin K antagonist e.g. warfarin (excludes other novel oral anticoagulants)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
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.	Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
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.	Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
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.	Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
Number of Participants With All Cause Death		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 Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
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.	Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
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.	Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
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).	Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
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.	Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
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.	Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Bristol-Myers Squibb

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2014
• Primary Completion (Actual): February 8, 2017
• Study Completion (Actual): February 8, 2017

Study Registration Dates

• First Submitted: February 5, 2014
• First Submitted That Met QC Criteria: March 26, 2014
• First Posted (Estimate): March 31, 2014

Study Record Updates

• Last Update Posted (Actual): May 23, 2018
• Last Update Submitted That Met QC Criteria: May 21, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: cardioversion; apixaban; oral anticoagulant; non-valvular atrial fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Micronutrients; Vitamins; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Antifibrinolytic Agents; Hemostatics; Coagulants; Vitamin K; Heparin; Apixaban
• Other Study ID Numbers: B0661025; CV185-267 (Other Identifier: Alias Study Number); 2014-001231-36 (EudraCT Number); EMANATE (Other Identifier: Alias Study Number)