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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)

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ClinicalTrials.gov Identifier: NCT02100228
Recruitment Status : Completed
First Posted : March 31, 2014
Results First Posted : April 10, 2018
Last Update Posted : May 23, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Pfizer

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 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
Actual Study Start Date : July 14, 2014
Actual Primary Completion Date : February 8, 2017
Actual Study Completion Date : February 8, 2017


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)




Primary Outcome Measures :
  1. Number of Participants With Acute Stroke Event [ 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) ]
    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).

  2. Number of Participants With Systemic Embolism Event [ 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) ]
    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.

  3. Number of Participants With Major Bleeding Event [ 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) ]
    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.

  4. Number of Participants With Clinically Relevant Non-Major Bleeding Events [ 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) ]
    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.

  5. 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 Measures :
  1. Time to First Attempt of Cardioversion [ Time Frame: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) ]
    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.

  2. Number of Participants With Different Type of Cardioversion Events [ Time Frame: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) ]
    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.

  3. Number of Cardioversion Attempt of Participants [ Time Frame: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) ]
    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.

  4. Number of Participants With Their Rhythm Status [ Time Frame: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) ]
    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).

  5. Duration of Hospital Stay of Participants [ Time Frame: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) ]
    Duration of hospital stay was defined as the number of hours from hospital admission to hospital discharge followed by early cardioversion.

  6. Number of Participants Who Used Image Guidance Approach [ Time Frame: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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
Saint 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
  Study Documents (Full-Text)

Documents provided by Pfizer:
Statistical Analysis Plan  [PDF] February 2, 2017
Study Protocol  [PDF] February 22, 2016


Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 )
EMANATE ( Other Identifier: Alias Study Number )
First Posted: March 31, 2014    Key Record Dates
Results First Posted: April 10, 2018
Last Update Posted: May 23, 2018
Last Verified: May 2018

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