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)
- Conditions
- Atrial Fibrillation
- Interventions
- Drug: Parenteral heparin and/or oral Vitamin K antagonist
- Registration Number
- NCT02100228
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1500
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Parenteral heparin and/or oral Vitamin K antagonist 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) Apixaban Apixaban -
- Primary Outcome Measures
Name Time Method Number of Participants With Acute Stroke Event 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).
Number of Participants With Systemic Embolism Event 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.
Number of Participants With Major Bleeding Event 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.
Number of Participants With Clinically Relevant Non-Major Bleeding Events 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.
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
Name Time Method Time to First Attempt of Cardioversion 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.
Number of Participants With Different Type of Cardioversion Events 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.
Number of Cardioversion Attempt of Participants 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.
Number of Participants With Their Rhythm Status 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).
Duration of Hospital Stay of Participants 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.
Number of Participants Who Used Image Guidance Approach 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.
Trial Locations
- Locations (164)
Policlinico Universitario Campus Biomedico
🇮🇹Roma, Lazio, Italy
Brasov Emergency Clinical County Hospital
🇷🇴Brasov, Romania
Prof.Dr.George I.M. Georgescu Cardiovascular Diseases Institute
🇷🇴Iasi, Romania
Hospital Universitario San Juan de Alicante
🇪🇸San Juan, Alicante, Spain
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
"Prof. Dr.C.C. lliescu" Emergency Institute for Cardiovascular Diseases Bucharest
🇷🇴Bucharest, Romania
Cardio Med SRL
🇷🇴Targu Mures, Romania
Tirgu Mures Emergency Clinical County Hospital
🇷🇴Tirgu Mures, Romania
The University of Chicago Medical Center Investigational Drug Service Pharmacy (office/storage)
🇺🇸Chicago, Illinois, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Aim Clinic
🇺🇸Louisville, Kentucky, United States
New York-Presbyterian/Queens
🇺🇸Flushing, New York, United States
UK Good Samaritan Medical Office Building
🇺🇸Lexington, Kentucky, United States
Chicago Medical Research, LLC
🇺🇸Hazel Crest, Illinois, United States
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
ProMedica Toledo Hospital
🇺🇸Toledo, Ohio, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Integrated Medical Services, Inc./IMS Cardiology
🇺🇸Avondale, Arizona, United States
University of Kentucky Medical Center Gill Heart Institute
🇺🇸Lexington, Kentucky, United States
University of Missouri Health Care System
🇺🇸Columbia, Missouri, United States
Charité - Campus Virchow-Klinikum
🇩🇪Berlin, Germany
The University of Chicago Medical Center Investigational Drug Service Pharmacy
🇺🇸Chicago, Illinois, United States
Brookwood Medical Center
🇺🇸Birmingham, Alabama, United States
Good Samaritan Hospital
🇺🇸Lexington, Kentucky, United States
State University of New York (SUNY) Downstate Medical Center
🇺🇸Brooklyn, New York, United States
University of Louisville Hospital
🇺🇸Louisville, Kentucky, United States
University of Massachusetts Worcester
🇺🇸Worcester, Massachusetts, United States
Columbia University Medical Center/NY Presbyterian Hospital
🇺🇸New York, New York, United States
University of Missouri Health System
🇺🇸Columbia, Missouri, United States
Cliniques Universitatires UCL Mont-Godinne
🇧🇪Yvoir, Belgium
Einstein Healthcare Network
🇺🇸Philadelphia, Pennsylvania, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
St. Francis Medical Center
🇺🇸Midlothian, Virginia, United States
ProMedica Physicians Cardiology
🇺🇸Toledo, Ohio, United States
Charitè Campus Mitte/ Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie
🇩🇪Berlin, Germany
Sint-Franciskusziekenhuis
🇧🇪Heusden-Zolder, Limburg, Belgium
AZ Delta
🇧🇪Roeselare, Belgium
Institut de Cardiologie de Montreal -ICM / Montreal Heart Institute-MHI
🇨🇦Montreal, Quebec, Canada
McGill University Health Center
🇨🇦Montreal, Quebec, Canada
Cardiology Consultants of Philadelphia
🇺🇸Bristol, Pennsylvania, United States
Rutgers Robert Wood Johnson Medical School Cardiovascular Institute
🇺🇸New Brunswick, New Jersey, United States
Hillcrest Medical Center Pharmacy
🇺🇸Tulsa, Oklahoma, United States
Oklahoma Heart Institute at Hillcrest Medical Center
🇺🇸Tulsa, Oklahoma, United States
Jessa Ziekenhuis-Campus Virga Jesse
🇧🇪Hasselt, Belgium
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Southeast Texas Cardiology Associates II, L.L.P.
🇺🇸Beaumont, Texas, United States
Zentrum fuer klinische Pruefungen in der Facharztzentrum Dresden-Neustadt GbR
🇩🇪Dresden, Germany
Cardio Centrum Ludwigsburg Bietigheim
🇩🇪Ludwigsburg, Baden-württemberg, Germany
Centro Cardiologico Monzino
🇮🇹Milano, Italy
Keimyung University Dongsan Medical Center
🇰🇷Daegu-si, Korea, Republic of
Medizinisches Versorgungszentrum am Küchwald GmbH
🇩🇪Chemnitz, Germany
Unklinik Heidelberg
🇩🇪Heidelberg, Germany
Hadassah University Hospital - Mount Scopus
🇮🇱Jerusalem, Israel
Sydvestjysk Sygehus Esbjerg
🇩🇰Esbjerg, Denmark
Clinical Trial Network Services
🇮🇱Tel Aviv, Israel
Praxisklinik Herz und Gefäße
🇩🇪Dresden, Germany
Universitätsklinikum Hamburg Eppendorf, Universitäres Herzzentrum Hamburg GmbH
🇩🇪Hamburg, Germany
Slagelse Hospital
🇩🇰Slagelse, Sjaelland, Denmark
Southlake Regional Health Centre
🇨🇦Newmarket, Ontario, Canada
Johanniter-Krankenhaus Rheinhausen GmbH/ Klinik fuer Kardiologie
🇩🇪Duisburg, Germany
Vivantes Netzwerk fuer Gesundhelt GmbH, Humboldt Klinikum
🇩🇪Berlin, Germany
Klinikum Heidenheim
🇩🇪Heidenheim, Germany
Yeungnam University Hospital
🇰🇷Deagu, Korea, Republic of
Southeast Texas Cardiology Associates II, L.L.P
🇺🇸Beaumont, Texas, United States
UZ Leuven
🇧🇪Leuven, Vlaams Brabant, Belgium
Vivantes -Netzwerk fuer Gesundheit GmbH - Klinikum Neukoelln
🇩🇪Berlin, Germany
Regionshospitalet Silkeborg
🇩🇰Silkeborg, Midtjylland, Denmark
Hillel Yaffe Medical Center
🇮🇱Hadera, Israel
Tosei General Hospital
🇯🇵Seto, Aichi, Japan
Craiova Emergency Clinical County Hospital
🇷🇴Craiova, Romania
Ajou University Hospital, Division of Cardiology
🇰🇷Suwon, Korea, Republic of
Rambam Health Care Campus
🇮🇱Haifa, Israel
Hospital de Basurto
🇪🇸Bilbao, Spain
Cardiocenter Rhythmologie
🇩🇪Leipzig, Germany
HaEmek Medical Center
🇮🇱Afula, Israel
Lady Davis Carmel Medical Center
🇮🇱Haifa, Israel
Sahlgrenska University Hospital
🇸🇪Göteborg, Sweden
Johann-Wolfgang Goethe-Universitaet
🇩🇪Frankfurt/Main, Germany
Korea University Anam Hospital, cardiology and Electrophysiology
🇰🇷Seoul, Korea, Republic of
Azienda Ospedaliero Universitaria Careggi, Medicina e Cardiologia Geriatrica
🇮🇹Firenze, Italy
Kaplan Medical Center
🇮🇱Rehovot, Israel
Presidio Ospedaliero San Donato
🇮🇹Arezzo, Italy
Krankenhaus Nordwest GmbH
🇩🇪Frankfurt am Main, Germany
Hospital Universitario Infanta Sofía
🇪🇸San Sebastián De Los Reyes, Madrid, Spain
DAI Malattie Cardiovascolari e Respiratorie
🇮🇹Roma, Italy
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Universitatsmedizin Greifswald
🇩🇪Greifswald, Germany
The Baruch Padeh Medical Center
🇮🇱Tiberias, Israel
Osaka General Medical Center
🇯🇵Osaka, Japan
Galilee Medical Center
🇮🇱Nahariya, Israel
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Dong-A Unversity Hospital
🇰🇷Busan, Korea, Republic of
Katholisches Klinikum Mainz
🇩🇪Mainz, Germany
Prof. Dr. med. Werner Jung,Schwarzwald - Baar Klinikum
🇩🇪Villingen-Schwenningen, Germany
Nippon Medical School Hospital
🇯🇵Tokyo, Japan
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
I.R.C.C.S. Ospedale San Raffaele S.r.l.
🇮🇹Milano, Lombardia, Italy
ZIV Medical Center
🇮🇱Safed, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Rabin Medical Center
🇮🇱Petach Tikva, Israel
The Catholic University of Korea Seoul ST.MARY'S Hospital
🇰🇷Seoul, Korea, Republic of
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Consorci Sanitari de Terrassa Hospital de Terrassa
🇪🇸Terrassa, Cataluna, Spain
Skelleftea Country Hospital
🇸🇪Skelleftea, Sweden
Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Linkopings Universitetssjukhus Kardiologkliniken
🇸🇪Linkoping, Sweden
Universitetssjukhuset i Orebro/ Hjartmottagningen
🇸🇪Orebro, Sweden
Franciscan Physician Network-Indiana Heart Physicians
🇺🇸Indianapolis, Indiana, United States
Franciscan St. Francis Health
🇺🇸Indianapolis, Indiana, United States
Regionhospitalet Viborg
🇩🇰Viborg, Denmark
Josephs-Hospital Warendorf
🇩🇪Warendorf, Germany
Cardiovascular Associates of the Southeast, LLC
🇺🇸Birmingham, Alabama, United States
Chula Vista Cardiac Center
🇺🇸Chula Vista, California, United States
Certified Physician Investigator Research Group LLC
🇺🇸Altamonte Springs, Florida, United States
Orlando Heart Specialists
🇺🇸Altamonte Springs, Florida, United States
University of Kentucky HealthCare/Albert. B, Chandler Hospital
🇺🇸Lexington, Kentucky, United States
University of Kentucky Gill Heart Institute
🇺🇸Lexington, Kentucky, United States
University of Massachusetts Worcester Research Pharmacy
🇺🇸Worcester, Massachusetts, United States
Abbott Northwestern Hopsital - Allina Health System
🇺🇸Minneapolis, Minnesota, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
University of Missouri Health System, Investigational Drug Serivce
🇺🇸Columbia, Missouri, United States
Saint Luke's Lipid and Diabetes Research Center
🇺🇸Kansas City, Missouri, United States
Mercy Hospital St. Louis
🇺🇸Saint Louis, Missouri, United States
Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States
Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Bryn Mawr Medical Specialist Association
🇺🇸Bryn Mawr, Pennsylvania, United States
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Baptist Hospital of Southeast Texas - Beaumont
🇺🇸Beaumont, Texas, United States
Utah Cardiology, PC
🇺🇸Layton, Utah, United States
Cardiology consultants of Philadelphia
🇺🇸Yardley, Pennsylvania, United States
Cardiovascular Associates of Virginia-Bon Secours St. Mary's Hospital
🇺🇸Midlothian, Virginia, United States
Southeast Texas Clinical Research Center
🇺🇸Beaumont, Texas, United States
University Hospital Ghent
🇧🇪Gent, Oost-vlaanderen, Belgium
Dominion Cardiovascular Specialists PLLC
🇺🇸Richmond, Virginia, United States
Algemeen Ziekenhuis Klina
🇧🇪Brasschaat, Belgium
Grand Hopital de Charleroi asbl
🇧🇪Gilly, Belgium
Klinikum Links der Weser gGmbH
🇩🇪Bremen, Germany
Klinikum Coburg gGmbH
🇩🇪Coburg, Germany
Klinikum Ingolstadt/ Medizinische Klinik I und IV
🇩🇪Ingolstadt, Germany
Herzzentrum Leipzig GmbH/ Abteilung für Rhythmologie
🇩🇪Leipzig, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
🇩🇪Mainz, Germany
Kliniken Maria Hilf GmbH
🇩🇪Moenchengladbach, Germany
Barzilai Medical Center (Cardiology)
🇮🇱Ashkelon, Israel
Soroka University Medical Centre, Soroka Medical center
🇮🇱Be'er Sheva, Israel
Ospedale Generale Regionale F. Miulli-Ente Ecclesiastico
🇮🇹Acquaviva Delle Fonti (BA), Bari, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
🇮🇹Torrette Di Ancona, Marche, Italy
Toho University Ohashi Medical Center
🇯🇵Meguro-ku, Tokyo, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Bucharest Emergency University Hospital
🇷🇴Bucharest, Romania
Cluj-Napoca Rehabilitation Clinical Hospital
🇷🇴Cluj-Napoca, Romania
Hospital de Sierrallana
🇪🇸Torrelavega, Cantabria, Spain
Danderyds Sjukhus AB
🇸🇪Stockholm, Sodermanlands LAN, Sweden
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Akademiska Sjukhuset I Uppsala/ Kardiologikliniken
🇸🇪Uppsala, Uppsala IAN, Sweden
Sodersjukhuset
🇸🇪Stockholm, Sweden
University of Louisville Clinical Trials Unit
🇺🇸Louisville, Kentucky, United States
Electrophysiology Associates
🇺🇸Hackensack, New Jersey, United States
Cardiology Outpatient Clinic
🇺🇸Louisville, Kentucky, United States
Robley Rex VA Medical Center
🇺🇸Louisville, Kentucky, United States
Alexandria Cardiology Clinic
🇺🇸Alexandria, Louisiana, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States