We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02100228
Recruitment Status : Completed
First Posted : March 31, 2014
Last Update Posted : February 24, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Apixaban Drug: Parenteral heparin and/or oral Vitamin K antagonist Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : July 2014
Primary Completion Date : February 2017
Study Completion Date : February 2017


Arms and Interventions

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)


Outcome Measures

Primary Outcome Measures :
  1. Acute stroke [ Time Frame: Events will be collected up to 30 days post cardioversion ]
    An acute stroke is defined as a new focal neurological deficit of sudden onset, lasting at least 24 hours, that is not due to a readily identifiable non-vascular cause. This will be assessed by the Investigator.

  2. Systemic embolism [ Time Frame: Events will be collected up to 30 days post cardioversion ]
    A clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), which is supported by evidence of embolism from surgical specimens, autopsy, angiography, or other objective testing. This will be assessed by the Investigator.

  3. Major Bleeding [ Time Frame: Events will be collected up to 30 days post cardioversion ]
    Defined as new onset, visible bleeding or signs or symptoms suggestive of bleeding with confirmatory imaging techniques which can detect the presence of blood. The definition of major bleeding is adapted from the International Society on Thrombosis and Hemostasis (ISTH) definition. This will be assessed by the Investigator.

  4. Clinically Relevant Non-Major Bleeding [ Time Frame: Events will be collected up to 30 days post cardioversion ]
    The definition is adapted from International Society on Thrombosis and Hemostasis (ISTH) definition. This will be assessed by the Investigator.

  5. All cause death [ Time Frame: Events will be collected up to 30 days post cardioversion ]
    Death


Secondary Outcome Measures :
  1. Cardioversion Details [ Time Frame: up to 90 days ]
    The timing, type, and the attempts of cardioversion will be collected.

  2. Length of in-hospital stay [ Time Frame: Number of hours will be collected from admission for cardioversion to 30 days post cardioversion. ]
    Length of in-hospital stay is defined as the number of hours from hospital admission to hospital discharge for cardioversion. Mean and median duration will be summarized.

  3. Rhythm status [ Time Frame: Pre & post cardioversion and 30 days post cardioversion ]
    Rhythm status pre- and post cardioversion as recorded by ECG will be collected.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100228


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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02100228     History of Changes
Other Study ID Numbers: B0661025
CV185-267 ( Other Identifier: Alias Study Number )
2014-001231-36 ( EudraCT Number )
EMENATE ( Other Identifier: Alias Study Number )
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017

Keywords provided by Pfizer:
apixaban
oral anticoagulant
non-valvular atrial fibrillation
cardioversion

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vitamins
Vitamin K
Calcium heparin
Apixaban
Heparin
Anticoagulants
Micronutrients
Growth Substances
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antifibrinolytic Agents
Hemostatics
Coagulants