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AzTrials

Atrial FibrillationPhase 4EMANATENCT02100228

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)

A Phase 4 study testing Apixaban and Parenteral heparin and/or oral Vitamin K antagonist in people with Atrial Fibrillation, run by Pfizer at 165 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Apixaban and Parenteral heparin and/or oral Vitamin K antagonist
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,500 participants
Where
165 sitesin 12 countries
Study dates
14 Jul 2014to 8 Feb 2017
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

165 sites in 12 countries.

165 sites in 12 countries

United States63 sites

  • Alexandria Cardiology Clinic

    Alexandria, Louisiana, 71301

  • Certified Physician Investigator Research Group LLC

    Altamonte Springs, Florida, 32714

  • Orlando Heart Specialists

    Altamonte Springs, Florida, 32714

  • Integrated Medical Services, Inc./IMS Cardiology

    Avondale, Arizona, 85392

  • Baptist Hospital of Southeast Texas - Beaumont

    Beaumont, Texas, 77701

  • Southeast Texas Cardiology Associates II, L.L.P.

    Beaumont, Texas, 77702

  • Southeast Texas Cardiology Associates II, L.L.P

    Beaumont, Texas, 77702

  • Southeast Texas Clinical Research Center

    Beaumont, Texas, 77702

  • Brookwood Medical Center

    Birmingham, Alabama, 35209

  • Cardiovascular Associates of the Southeast, LLC

    Birmingham, Alabama, 35243

  • Cardiology Consultants of Philadelphia

    Bristol, Pennsylvania, 19007

  • State University of New York (SUNY) Downstate Medical Center

    Brooklyn, New York, 11203

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Bryn Mawr Medical Specialist Association

    Bryn Mawr, Pennsylvania, 19010

  • The University of Chicago Medical Center Investigational Drug Service Pharmacy (office/storage)

    Chicago, Illinois, 60637

  • The University of Chicago Medical Center Investigational Drug Service Pharmacy

    Chicago, Illinois, 60637

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Chula Vista Cardiac Center

    Chula Vista, California, 91910

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • University of Missouri Health Care System

    Columbia, Missouri, 65212

  • University of Missouri Health System, Investigational Drug Serivce

    Columbia, Missouri, 65212

  • University of Missouri Health System

    Columbia, Missouri, 65212

  • New York-Presbyterian/Queens

    Flushing, New York, 11355

  • Electrophysiology Associates

    Hackensack, New Jersey, 07601

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Chicago Medical Research, LLC

    Hazel Crest, Illinois, 60429

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Franciscan Physician Network-Indiana Heart Physicians

    Indianapolis, Indiana, 46237

  • Franciscan St. Francis Health

    Indianapolis, Indiana, 46237

  • Saint Luke's Lipid and Diabetes Research Center

    Kansas City, Missouri, 64111

  • Utah Cardiology, PC

    Layton, Utah, 84041

  • UK Good Samaritan Medical Office Building

    Lexington, Kentucky, 40508-2678

  • Good Samaritan Hospital

    Lexington, Kentucky, 40508-3008

  • University of Kentucky Medical Center Gill Heart Institute

    Lexington, Kentucky, 40536-0200

  • University of Kentucky Gill Heart Institute

    Lexington, Kentucky, 40536

  • University of Kentucky HealthCare/Albert. B, Chandler Hospital

    Lexington, Kentucky, 40536

  • Aim Clinic

    Louisville, Kentucky, 40202

  • Cardiology Outpatient Clinic

    Louisville, Kentucky, 40202

  • University of Louisville Clinical Trials Unit

    Louisville, Kentucky, 40202

  • University of Louisville Hospital

    Louisville, Kentucky, 40202

  • Robley Rex VA Medical Center

    Louisville, Kentucky, 40206

  • Cardiovascular Associates of Virginia-Bon Secours St. Mary's Hospital

    Midlothian, Virginia, 23114

  • St. Francis Medical Center

    Midlothian, Virginia, 23114

  • Abbott Northwestern Hopsital - Allina Health System

    Minneapolis, Minnesota, 55407

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08901

  • Rutgers Robert Wood Johnson Medical School Cardiovascular Institute

    New Brunswick, New Jersey, 08901

  • Columbia University Medical Center/NY Presbyterian Hospital

    New York, New York, 10032

  • ProMedica Physicians Cardiology

    Oregon, Ohio, 43616

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

  • Einstein Healthcare Network

    Philadelphia, Pennsylvania, 19141

  • Dominion Cardiovascular Specialists PLLC

    Richmond, Virginia, 23225

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Mercy Hospital St. Louis

    St Louis, Missouri, 63141

  • ProMedica Toledo Hospital

    Toledo, Ohio, 43606

  • ProMedica Physicians Cardiology

    Toledo, Ohio, 43615

  • Hillcrest Medical Center Pharmacy

    Tulsa, Oklahoma, 74104

  • Oklahoma Heart Institute at Hillcrest Medical Center

    Tulsa, Oklahoma, 74104

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104

  • University of Massachusetts Worcester Research Pharmacy

    Worcester, Massachusetts, 01655

  • University of Massachusetts Worcester

    Worcester, Massachusetts, 01655

  • Cardiology consultants of Philadelphia

    Yardley, Pennsylvania, 19067

Other trials in United States

Germany26 sites

  • Charitè Campus Mitte/ Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie

    Berlin, 10117

  • Vivantes -Netzwerk fuer Gesundheit GmbH - Klinikum Neukoelln

    Berlin, 12351

  • Charité - Campus Virchow-Klinikum

    Berlin, 13353

  • Vivantes Netzwerk fuer Gesundhelt GmbH, Humboldt Klinikum

    Berlin, 13509

  • Klinikum Links der Weser gGmbH

    Bremen, 28277

  • Medizinisches Versorgungszentrum am Küchwald GmbH

    Chemnitz, 09113

  • Klinikum Coburg gGmbH

    Coburg, 96450

  • Zentrum fuer klinische Pruefungen in der Facharztzentrum Dresden-Neustadt GbR

    Dresden, 01099

  • Praxisklinik Herz und Gefäße

    Dresden, 01324

  • Johanniter-Krankenhaus Rheinhausen GmbH/ Klinik fuer Kardiologie

    Duisburg, 47228

  • Krankenhaus Nordwest GmbH

    Frankfurt am Main, 60488

  • Johann-Wolfgang Goethe-Universitaet

    Frankfurt am Main, 60590

  • Universitatsmedizin Greifswald

    Greifswald, 17475

  • Universitätsklinikum Hamburg Eppendorf, Universitäres Herzzentrum Hamburg GmbH

    Hamburg, 20246

  • Unklinik Heidelberg

    Heidelberg, 69120

  • Klinikum Heidenheim

    Heidenheim, 89522

  • Klinikum Ingolstadt/ Medizinische Klinik I und IV

    Ingolstadt, 85049

  • Cardiocenter Rhythmologie

    Leipzig, 04289

  • Herzzentrum Leipzig GmbH/ Abteilung für Rhythmologie

    Leipzig, 04289

  • Cardio Centrum Ludwigsburg Bietigheim

    Ludwigsburg, Baden-Wurttemberg, 71634

  • Katholisches Klinikum Mainz

    Mainz, 55131

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, 55131

  • Kliniken Maria Hilf GmbH

    Mönchengladbach, 41063

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

  • Prof. Dr. med. Werner Jung,Schwarzwald - Baar Klinikum

    Villingen-Schwenningen, 78052

  • Josephs-Hospital Warendorf

    Warendorf, 48231

Other trials in Germany

Israel15 sites

  • HaEmek Medical Center

    Afula, 18101

  • Barzilai Medical Center (Cardiology)

    Ashkelon, 78278

  • Soroka University Medical Centre, Soroka Medical center

    Beersheba, 84101

  • Hillel Yaffe Medical Center

    Hadera, 38100

  • Rambam Health Care Campus

    Haifa, 31096

  • Lady Davis Carmel Medical Center

    Haifa, 34362

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah University Hospital - Mount Scopus

    Jerusalem, 91240

  • Galilee Medical Center

    Nahariya, 22100

  • Rabin Medical Center

    Petah Tikva, 49100

  • Kaplan Medical Center

    Rehovot, 76100

  • ZIV Medical Center

    Safed, 13100

  • Clinical Trial Network Services

    Tel Aviv, 64239

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • The Baruch Padeh Medical Center

    Tiberias, 1528001

Other trials in Israel

South Korea12 sites

  • Dong-A Unversity Hospital

    Busan, 49201

  • Keimyung University Dongsan Medical Center

    Daegu, 700-712

  • Yeungnam University Hospital

    Deagu, 705703

  • Chonnam National University Hospital

    Gwangju, 501-757

  • Korea University Guro Hospital

    Seoul, Korea, Republic of, 152-703

  • Seoul National University Hospital

    Seoul, 110-744

  • Severance Hospital, Yonsei University Health System

    Seoul, 120752

  • Samsung Medical Center

    Seoul, 135-710

  • Korea University Anam Hospital, cardiology and Electrophysiology

    Seoul, 136-705

  • The Catholic University of Korea Seoul ST.MARY'S Hospital

    Seoul, 137701

  • Asan Medical Center

    Seoul, 138-736

  • Ajou University Hospital, Division of Cardiology

    Suwon, 443-380

Other trials in South Korea

Belgium8 sites

  • Algemeen Ziekenhuis Klina

    Brasschaat, 2930

  • University Hospital Ghent

    Ghent, Oost-vlaanderen, 9000

  • Grand Hopital de Charleroi asbl

    Gilly, 6060

  • Jessa Ziekenhuis-Campus Virga Jesse

    Hasselt, 3500

  • Sint-Franciskusziekenhuis

    Heusden-Zolder, Limburg, 3550

  • UZ Leuven

    Leuven, Vlaams Brabant, 3000

  • AZ Delta

    Roeselare, 8800

  • Cliniques Universitatires UCL Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

Italy8 sites

  • Ospedale Generale Regionale F. Miulli-Ente Ecclesiastico

    Acquaviva Delle Fonti (BA), BARI, 70021

  • Presidio Ospedaliero San Donato

    Arezzo, 52100

  • Azienda Ospedaliero Universitaria Careggi, Medicina e Cardiologia Geriatrica

    Florence, 50134

  • I.R.C.C.S. Ospedale San Raffaele S.r.l.

    Milan, Lombardy, 20132

  • Centro Cardiologico Monzino

    Milan, 20138

  • DAI Malattie Cardiovascolari e Respiratorie

    Roma, 00161

  • Policlinico Universitario Campus Biomedico

    Rome, Lazio, 00128

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

    Torrette Di Ancona, The Marches, 60020

Other trials in Italy

Romania8 sites

  • Brasov Emergency Clinical County Hospital

    Brasov, 500326

  • "Prof. Dr.C.C. lliescu" Emergency Institute for Cardiovascular Diseases Bucharest

    Bucharest, 022328

  • Bucharest Emergency University Hospital

    Bucharest, 050098

  • Cluj-Napoca Rehabilitation Clinical Hospital

    Cluj-Napoca, 400347

  • Craiova Emergency Clinical County Hospital

    Craiova, 200642

  • Prof.Dr.George I.M. Georgescu Cardiovascular Diseases Institute

    Iași, 700503

  • Cardio Med SRL

    Târgu Mureş, 540124

  • Tirgu Mures Emergency Clinical County Hospital

    Târgu Mureş, 540139

Other trials in Romania

Spain7 sites

  • Hospital de Basurto

    Bilbao, 48013

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario San Juan de Alicante

    San Juan, Alicante, 03550

  • Hospital Universitario Infanta Sofía

    San Sebastián de los Reyes, Madrid, 28702

  • Consorci Sanitari de Terrassa Hospital de Terrassa

    Terrassa, Catalonia, 08227

  • Hospital de Sierrallana

    Torrelavega, Cantabria, 39300

Other trials in Spain

Sweden7 sites

  • Sahlgrenska University Hospital

    Gothenburg, 41345

  • Linkopings Universitetssjukhus Kardiologkliniken

    Linköping, 581 85

  • Universitetssjukhuset i Orebro/ Hjartmottagningen

    Örebro, 701 85

  • Skelleftea Country Hospital

    Skellefteå, 931 86

  • Danderyds Sjukhus AB

    Stockholm, Södermanland County

  • Sodersjukhuset

    Stockholm, 11883

  • Akademiska Sjukhuset I Uppsala/ Kardiologikliniken

    Uppsala, Uppsala IAN

Other trials in Sweden

Denmark4 sites

  • Sydvestjysk Sygehus Esbjerg

    Esbjerg, 6700

  • Regionshospitalet Silkeborg

    Silkeborg, Central Jutland, DK-8600

  • Slagelse Hospital

    Slagelse, Region Sjælland, DK-4200

  • Regionhospitalet Viborg

    Viborg, DK-8800

Other trials in Denmark

Japan4 sites

  • Toho University Ohashi Medical Center

    Meguro-ku, Tokyo, 153-8515

  • Osaka General Medical Center

    Osaka, 558-8558

  • Tosei General Hospital

    Seto, Aichi-ken, 489-8642

  • Nippon Medical School Hospital

    Tokyo, 113-8603

Other trials in Japan

Canada3 sites

  • Institut de Cardiologie de Montreal -ICM / Montreal Heart Institute-MHI

    Montreal, Quebec, H1T 1C8

  • McGill University Health Center

    Montreal, Quebec, H3G 1A4

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9

Other trials in Canada

About this study

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

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.

Being tested
Apixaban, Parenteral heparin and/or oral Vitamin K antagonist
Keywords
apixaban, oral anticoagulant, non-valvular atrial fibrillation, cardioversion
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApixabanDrug

    Oral, 2.5 or 5 mg BID

  • Parenteral heparin and/or oral Vitamin K antagonistDrug

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

Study groups in NCT02100228
Study groupRoleWhat they receive
ApixabanExperimentalNot described
Receives: Drug: Apixaban
Parenteral heparin and/or oral Vitamin K antagonistActive comparatorParenteral heparin and/or locally used oral Vitamin K antagonist e.g. warfarin (excludes other novel oral anticoagulants)
Receives: Drug: Parenteral heparin and/or oral Vitamin K antagonist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)

  2. 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.

    Measured: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)

  3. 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.

    Measured: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)

  4. 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.

    Measured: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)

  5. Number of Participants With All Cause Death

    Measured: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)

Secondary outcomes (6)

  1. 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.

    Measured: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)

  2. 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.

    Measured: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)

  3. 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.

    Measured: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)

  4. 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).

    Measured: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)

  5. 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.

    Measured: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)

  6. 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.

    Measured: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2014 (estimated)
  2. Study start14 Jul 2014
  3. Primary completion8 Feb 2017
  4. Study completion8 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02100228
Sponsor's protocol ID
B0661025
Other IDs
CV185-267, 2014-001231-36, EMANATE, 2014
Acronym
EMANATE
Status last verified
May 2018
First submitted
5 Feb 2014
Last updated
23 May 2018
Data monitoring committee
Yes

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.

    PubMed 29659797

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Apixaban and Parenteral heparin and/or oral Vitamin K antagonist in people with Atrial Fibrillation, run by Pfizer at 165 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 165 sites in United States, Germany, Israel, South Korea, Belgium and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02100228, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2018.

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