AzTrials
AzTrials

Acute Coronary SyndromesPhase 4NCT02415400

A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart

A Phase 4 study testing Apixaban, vitamin K antagonist and Acetylsalicylic acid in people with Acute Coronary Syndromes, run by Bristol-Myers Squibb at 626 sites in 37 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

The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. Read more about this study

Who is it for?
Ages 18 to 95 years
Conditions the study is for
Acute Coronary Syndromes
What is being tested?
Apixaban, vitamin K antagonist and Acetylsalicylic acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,614 participants
Where
626 sitesin 37 countries
Study dates
4 Jun 2015to 10 Nov 2018
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 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults with either active or a history of non-valvular atrial fibrillation or flutter with the planned or existing use of an oral anticoagulant for prophylaxis of thromboembolism. In addition, subjects must have had an acute coronary syndrome or percutaneous coronary intervention with a stent within the prior 14 days
  • Planned use of antiplatelet agents for at least 1 to 6 months
  • Males and Females ≥ 18 years of age
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug

Who cannot join

  • Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve)
  • Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine clearance < 30 mL/min
  • Patients with a history of intracranial hemorrhage
  • Patients have had or will undergo Coronary arterial bypass graft (CABG) for their index acute coronary syndrome (ACS) event
  • Patients with known ongoing bleeding and patients with known coagulopathies
  • Any contraindications or allergies to VKA, apixaban, or to intended P2Y12 antagonists or to aspirin

Trial locations and contacts

626 sites in 37 countries.

626 sites in 37 countries

United States143 sites

  • Capital Cardiology Associates

    Albany, New York, 12211

  • Alexandria Cardiology Clinic

    Alexandria, Louisiana, 71301

  • Comprehensive Cardiovascular Specialists

    Alhambra, California, 91801

  • Great Lakes Heart Center of Alpena

    Alpena, Michigan, 49707

  • Orlando Heart Specialists

    Altamonte Springs, Florida, 32714

  • Local Institution

    Ann Arbor, Michigan, 48109

  • Asheville Cardiology Associates PA

    Asheville, North Carolina, 28801

  • Athens Regional Cariology Group

    Athens, Georgia, 30606

  • Local Institution

    Atlanta, Georgia, 30342

  • Augusta University

    Augusta, Georgia, 30912

  • University Of Colorado

    Aurora, Colorado, 80045

  • Local Institution

    Austin, Texas, 78705

  • Local Institution

    Austin, Texas, 78758

  • Local Institution

    Billings, Montana, 59101

  • Cardiovascular Associates of the Southeast, LLC

    Birmingham, Alabama, 35243

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-3410

  • Local Institution

    Bloomington, Indiana, 47403

  • Saint Lukes Idaho Cardiology Associates

    Boise, Idaho, 83712

  • Local Institution

    Bradenton, Florida, 34209

  • New York-Presbyterian Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

  • Local Institution

    Brooklyn, New York, 11217

  • Buffalo Heart Group LLP

    Buffalo, New York, 14215

  • University of Vermont

    Burlington, Vermont, 05403

  • Aultman Hospital

    Canton, Ohio, 44710

  • University of North Carolina School of Medicine

    Chapel Hill, North Carolina, 27599

  • Clearwater Cardiovascular and Interventional Consultants

    Clearwater, Florida, 33756

  • Local Institution

    Clearwater, Florida, 33756

  • Missouri Cardiovascular Specialists

    Columbia, Missouri, 65201

  • Local Institution

    Columbia, Missouri, 65212

  • Columbia Heart

    Columbia, South Carolina, 29204

  • Local Institution

    Columbus, Ohio, 43214

  • Georgia Heart Specialists

    Covington, Georgia, 30014

  • Saint Elizabeth Healthcare

    Crestview Hills, Kentucky, 41017

  • Local Institution

    Culver City, California, 90230

  • Local Institution

    Cumming, Georgia, 30041

  • Local Institution

    Dallas, Texas, 75216

  • Midwest Cardiovascular Research Foundation

    Davenport, Iowa, 52803

  • Daytona Heart Group

    Daytona Beach, Florida, 32114

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Local Institution

    Detroit, Michigan, 48202

  • Durham VA Medical Center

    Durham, North Carolina, 27705

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Elkhart Clinic LLC

    Elkhart, Indiana, 46514

  • Saint Vincent Hospital

    Erie, Pennsylvania, 16544

  • Medicoricium, LLC

    Fairview Heights, Illinois, 62208

  • Virginia Heart

    Falls Church, Virginia, 22042

  • Local Institution

    Fort Lauderdale, Florida, 33316

  • San Antonio Military Medical Center

    Fort Sam Houston, Texas, 78234

  • Washington Township Medical Foundation

    Fremont, California, 94536

  • Local Institution

    Germantown, Tennessee, 38138

  • Upstate Cardiology PA

    Greenville, South Carolina, 29607

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Angiocardiac Care of Texas PA

    Houston, Texas, 77025

  • Local Institution

    Houston, Texas, 77084

  • Local Institution

    Houston, Texas, 77089

  • St Mary's Medical Center

    Huntington, West Virginia, 25702

  • California Heart Specialist, Inc.

    Huntington Beach, California, 92648

  • Grace Research, LLC

    Huntsville, Texas, 77340

  • Local Institution

    Huntsville, Texas, 77340

  • Roudebush VA Medical Center

    Indianapolis, Indiana, 46202

  • University of Iowa Stead Family Children's Hospital

    Iowa City, Iowa, 52242

  • Local Institution

    Jackson, Mississippi, 39216

  • Research Associates of Jackson

    Jackson, Tennessee, 38301

  • Local Institution

    Jacksonville, Florida, 32204

  • Local Institution

    Jacksonville, Florida, 32216

  • Local Institution

    Jacksonville Beach, Florida, 32250

  • Gateway Cardiology PC

    Jerseyville, Illinois, 62052

  • Freeman Health System

    Joplin, Missouri, 64804

  • Tenet Florida Physician Services

    Jupiter, Florida, 33458

  • Local Institution

    Kansas City, Kansas, 66160

  • Local Institution

    Katy, Texas, 77450

  • Local Institution

    Kettering, Ohio, 45429

  • Cardiovascular Research of Knoxville

    Knoxville, Tennessee, 37917

  • Knoxville Health Managment Associates Cardiology PPM LLC

    Knoxville, Tennessee, 37934

  • Foundation For Cardiovascular Medicine

    La Jolla, California, 92037

  • Imperial Health

    Lake Charles, Louisiana, 70601

  • Local Institution

    Lake Mary, Florida, 32746

  • Colorado Heart and Vascular

    Lakewood, Colorado, 80228

  • Heart Group

    Lancaster, Pennsylvania, 17603

  • Local Institution

    Lansing, Michigan, 48912

  • HCP Clinical Research LLC

    Las Vegas, Nevada, 89169

  • Virginia Heart Group Ltd

    Leesburg, Virginia, 20176

  • Clinical Trials of America-NC, LLC - PPDS

    Lenoir, North Carolina, 28645

  • Bryan Heart Hospital

    Lincoln, Nebraska, 68506

  • New Jersey Heart

    Linden, New Jersey, 07036

  • Local Institution

    Little Rock, Arkansas, 72204

  • Local Institution

    Long Beach, California, 90806

  • University of Louisville

    Louisville, Kentucky, 40202

  • Caprock Cardiac Center Research Institute

    Lubbock, Texas, 79410

  • Duke Cardiology and Cardiovascular Surgery of Lumberton

    Lumberton, North Carolina, 28358

  • Local Institution

    Miami, Florida, 33173

  • Local Institution

    Minden, Louisiana, 71055

  • Metropolitan Cardiology Consultants

    Minneapolis, Minnesota, 55433-4568

  • Clinical Trials of America LA LLC - PPDS

    Monroe, Louisiana, 71201

  • Local Institution

    Natick, Massachusetts, 01760

  • Mount Sinai-St. Lukes

    New York, New York, 10025

  • Mercer Bucks Cardiology

    Newton, Pennsylvania, 18940

  • Advocate Medical Group ? Cardiology and Pulmonology

    Normal, Illinois, 61761

  • Roper St. Francis Healthcare

    North Charleston, South Carolina, 29418

  • Local Institution

    Norwalk, Connecticut, 06851

  • Parkway Cardiology Associates PC

    Oak Ridge, Tennessee, 37830

  • Mediquest Research

    Ocala, Florida, 34471

  • South Suburban Cardiology

    Olympia Fields, Illinois, 60461

  • Local Institution

    Orlando, Florida, 32825

  • CP Cardiology Partners

    Palm Beach Gardens, Florida, 33410

  • Arizona Heart Rhythm Center

    Phoenix, Arizona, 85013

  • Local Institution

    Phoenix, Arizona, 85054

  • Local Institution

    Phoenix, Arkansas, 85015

  • Local Institution

    Plano, Texas, 75024

  • Hudson Valley Cardiovascular Practice, PC

    Poughkeepsie, New York, 12601

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Local Institution

    Rancho Mirage, California, 92270

  • Renown Regional Medical Center.

    Reno, Nevada, 89502

  • Reid Hospital and Health Care Services

    Richmond, Indiana, 47374

  • CJW Medical Center

    Richmond, Virginia, 23235

  • Carolina Cardiology Clinical Research Institute

    Rock Hill, South Carolina, 29732

  • Covenant Center for the Heart

    Saginaw, Michigan, 48602

  • Local Institution

    San Antonio, Texas, 78229

  • Mercury Medical LLC

    San Antonio, Texas, 78229

  • Local Institution

    San Diego, California, 92161

  • Scottsdale Osborn Medical Center

    Scottsdale, Arizona, 85251

  • Local Institution

    Sealy, Texas, 77474

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Cox Health Systems

    Springfield, Missouri, 65807

  • Gateway Cardiology PC

    St Louis, Missouri, 63128

  • St. Louis Heart and Vascular

    St Louis, Missouri, 63136

  • Bayfront Health St. Petersburg

    St. Petersburg, Florida, 33701

  • Manshadi Heart Institute

    Stockton, California, 95204

  • Local Institution

    Sugar Land, Texas, 77479

  • Local Institution

    Tampa, Florida, 33613

  • Local Institution

    Torrance, California, 90502

  • Local Institution

    Tucker, Georgia, 30084

  • Southern Arizona VA Health Care System

    Tucson, Arizona, 85723

  • Cardiology Associates Research LLC

    Tupelo, Mississippi, 38801

  • Victoria Heart and Vascular Center

    Victoria, Texas, 77901

  • Northeast Iowa Family Practice Center

    Waterloo, Iowa, 50702

  • Aspirus Research Institute

    Wausau, Wisconsin, 54401

  • Cardiology Partners

    Wellington, Florida, 33449

  • Local Institution

    Wichita, Kansas, 67203

  • Local Institution

    Willoughby, Ohio, 44094

  • Local Institution

    Wilmington, Delaware, 19803

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

  • WellSpan York Hospital

    York, Pennsylvania, 17405

Other trials in United States

Germany49 sites

  • Local Institution

    Bad Friedrichshall, 74177

  • Local Institution

    Bad Homburg, 61348

  • Local Institution

    Bad Homburg, 63148

  • Local Institution

    Berlin, 12351

  • Local Institution

    Berlin, 13347

  • Local Institution

    Berlin, 13353

  • Local Institution

    Bielefeld, 33604

  • Local Institution

    Brandenburg, 14770

  • Local Institution

    Bremen, 28277

  • Local Institution

    Chemnitz, 09111

  • Local Institution

    Cologne, 50937

  • Local Institution

    Dortmund, 44137

  • Local Institution

    Dresden, 01067

  • Local Institution

    Dresden, 01277

  • Local Institution

    Erfurt, 99089

  • Local Institution

    Erfurt, 99097

  • Local Institution

    Erlangen, 91054

  • Local Institution

    Essen, 45122

  • Local Institution

    Frankfurt am Main, 65929

  • Local Institution

    Freiburg im Breisgau, 79106

  • Local Institution

    Göttingen, 37075

  • Local Institution

    Greifswald, 17475

  • Local Institution

    Hamburg, 20099

  • Local Institution

    Hamburg, 22041

  • Local Institution

    Hennigsdorf, 16761

  • Local Institution

    Hoyerswerda, 02977

  • Local Institution

    Jena, 07747

  • Local Institution

    Karlsbad, 76307

  • Local Institution

    Kassel, 34121

  • Local Institution

    Lahr, 77933

  • Local Institution

    Leipzig, 04103

  • Local Institution

    Limburg, 65549

  • Local Institution

    Lübeck, 23538

  • Local Institution

    Lüdenscheid, 58515

  • Local Institution

    Magdeburg, 39120

  • Local Institution

    Mainz, 55131

  • Local Institution

    Mannheim, 68167

  • Local Institution

    Neuss, 41464

  • Local Institution

    Papenburg, 26871

  • Local Institution

    Regensburg, 93053

  • Local Institution

    Rostock, 18057

  • Local Institution

    Stendal, 39576

  • Local Institution

    Straubing, 94315

  • Local Institution

    Tübingen, 72076

  • Local Institution

    Ulm, 89077

  • Local Institution

    Villingen-Schwenningen, 78052

  • Local Institution

    Weiden i.d.OPf., 92637

  • Local Institution

    Worms, 67550

  • Local Institution

    Würzburg, 97080

Other trials in Germany

Argentina43 sites

  • Local Institution

    Bahía Blanca, Buenos Aires, B8000FTD

  • Local Institution

    Buenos Aires, BUA, 1180

  • Local Institution

    Buenos Aires, 1118

  • Local Institution

    Buenos Aires, 1430

  • Local Institution

    Buenos Aires, C1093AAS

  • Local Institution

    Buenos Aires, C1155ADP

  • Local Institution

    Buenos Aires, C1179AAB

  • Local Institution

    Buenos Aires, C1221ADC

  • Local Institution

    Buenos Aires, C1425AGC

  • Local Institution

    Buenos Aires, C1428CRC

  • Local Institution

    Buenos Aires, C1428DCO

  • Local Institution

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1406

  • Local Institution

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1431

  • Local Institution

    Córdoba, Córdoba Province, X5000JHGQ

  • Local Institution

    Córdoba, 5000

  • Local Institution

    Córdoba, 5016

  • Local Institution

    Córdoba, X5000AAX

  • Local Institution

    Córdoba, X5000EPU

  • Local Institution

    Córdoba, X5002AOQ

  • Local Institution

    Córdoba, X5004CDT

  • Local Institution

    Córdoba, X5006CBI

  • Local Institution

    Córdoba, X5008KKF

  • Local Institution

    Córdoba, X5016KEH

  • Local Institution

    Coronel Suárez, Buenos Aires, B7540DOL

  • Local Institution

    Corrientes, W3400AMZ

  • Local Institution

    Lanús Oeste, Buenos Aires, 4843

  • Local Institution

    Mar del Plata, Buenos Aires, 7500

  • Local Institution

    Mar del Plata, Buenos Aires, B7602CBM

  • Local Institution

    Quilmes, Buenos Aires, 1878

  • Local Institution

    Quilmes, Buenos Aires, B1878GEG

  • Local Institution

    Ramos Mejía, Buenos Aires, B1704ESN

  • Local Institution

    Ramos Mejía, Buenos Aires, B1704ETD

  • Local Institution

    Resistencia, Chaco Province, H3500CDL

  • Local Institution

    Rosario, Santa Fe Province, 2000

  • Local Institution

    Rosario, Santa Fe Province, S2000DSV

  • Local Institution

    Rosario, Santa Fe Province, S2000PBJ

  • Local Institution

    Santa Fe, 3000

  • Local Institution

    Santa Fe, S3000AOL

  • Local Institution

    Santa Fe, S3000EOZ

  • Local Institution

    Santiago del Estero

  • Local Institution

    Vicente López, Buenos Aires, B1602ABQ

  • Local Institution

    Villa Allende, Córdoba Province, 5105

  • Local Institution

    Villa María, Córdoba Province, X5901ACH

Other trials in Argentina

Brazil39 sites

  • Local Institution

    Aparecida de Goiânia, Goiás, 74915-520

  • Local Institution

    Belém, Pará, 66087-660

  • Local Institution

    Belo Horizonte, Minas Gerais, 30110-921

  • Local Institution

    Belo Horizonte, Minas Gerais, 30150-320

  • Local Institution

    Blumenau, Santa Catarina, 89010-906

  • Local Institution

    Brasília, Federal District, 70390-700

  • Local Institution

    Campina Grande do Sul, Paraná, 83430-000

  • Local Institution

    Campinas, São Paulo, 13060080

  • Local Institution

    Canoas, Rio Grande do Sul, 92425-900

  • Local Institution

    Colatina, Espírito Santo, 29702-020

  • Local Institution

    Goiânia, Goiás, 74210-050

  • Local Institution

    Itajaí, Santa Catarina, 88301-303

  • Local Institution

    Limeira, São Paulo, 13480-470

  • Local Institution

    Londrina, Paraná, 86010-450

  • Local Institution

    Marília, São Paulo, 17515-000

  • Local Institution

    Passo Fundo, Rio Grande do Sul, 99010-080

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90620-001

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90840-440

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Local Institution

    Recife, Pernambuco, 50100-060

  • Local Institution

    Recife, Pernambuco, 52051-380

  • Local Institution

    Rio de Janeiro, 22271-100

  • Local Institution

    S?o Paulo, São Paulo, 01327-010

  • Local Institution

    S?o Paulo, São Paulo, 04004-030

  • Local Institution

    S?o Paulo, São Paulo, 08270-070

  • Local Institution

    Salvador, Estado de Bahia, 40050-410

  • Local Institution

    Salvador, Estado de Bahia, 41253-190

  • Local Institution

    Salvador, Estado de Bahia, 41810-011

  • Local Institution

    Salvador, Estado de Bahia, 41950-275

  • Local Institution

    Santo André, São Paulo, 09030-010

  • Local Institution

    São José do Rio Preto, São Paulo, 15015-750

  • Local Institution

    São Paulo, 01418-100

  • Local Institution

    São Paulo, 05403-000

  • Local Institution

    Uberaba, Minas Gerais, 38025-260

  • Local Institution

    Uberlândia, Minas Gerais, 38400-902

  • Local Institution

    Votuporanga, São Paulo, 15500-003

Other trials in Brazil

Canada26 sites

  • Local Institution

    Cambridge, Ontario, N1R 7R1

  • Local Institution

    Edmonton, Alberta, T5H 3V9

  • Local Institution

    Edmonton, Alberta, T6G 2B7

  • Local Institution

    Edmonton, Alberta, T6K 4C1

  • Local Institution

    Greater Sudbury, Ontario, P3E 3B8

  • Local Institution

    Greater Sudbury, Ontario, P3E 5M4

  • Local Institution

    Green Field Park, Quebec, J4V 2H1

  • Local Institution

    Halifax, Nova Scotia, B3H1V7

  • Local Institution

    Kelowna, British Columbia, V1Y 1V6

  • Local Institution

    Laval, Quebec, H7M 3L9

  • Local Institution

    London, Ontario, N6A 5A5

  • Local Institution

    Longueuil, Quebec, J4M 2X1

  • Local Institution

    Montreal, Quebec, H3G 1A4

  • Local Institution

    Montreal, H2X 3E4

  • Local Institution

    New Westminster, British Columbia, V3L 3W4

  • Local Institution

    Oshawa, Ontario, L1J 2J9

  • Local Institution

    Regina, Saskatchewan, S4P 0W5

  • Local Institution

    Saint-Jean-sur-Richelieu, Quebec, J3A 1C3

  • Local Institution

    Saint-Jérôme, Quebec, J7Z 5T3

  • Local Institution

    Scarborough Village, Ontario, M1E 5E9

  • Local Institution

    Scarborough Village, Ontario, M1P 2T7

  • Local Institution

    Sherbrooke, Quebec, J1H 5N4

  • Local Institution

    St-Georges, Beauce, Quebec, G5Y 4T8

  • Local Institution

    Victoria, British Columbia, V8R 4R2

  • Local Institution

    Waterloo, Ontario, N2T 0C1

  • Local Institution

    Winnepeg, Manitoba, R2H 2A6

Other trials in Canada

Poland25 sites

  • Local Institution

    Bialystok, 15-276

  • Local Institution

    Bydgoszcz, 85-168

  • Local Institution

    Bytom, 41-902

  • Local Institution

    Chojnice, 89-600

  • Local Institution

    Gdynia, 81-423

  • Local Institution

    Gdynia, 81-472

  • Local Institution

    Katowice, 40-060

  • Local Institution

    Kielce, 25-020

  • Local Institution

    Krakow, 30-082

  • Local Institution

    Krakow, 31-202

  • Local Institution

    Krakow, 31-501

  • Local Institution

    Lodz, 91-078

  • Local Institution

    Lodz, 91-347

  • Local Institution

    Lodz, 92-213

  • Local Institution

    Lubin, 59-301

  • Local Institution

    Opole, 45-418

  • Local Institution

    Płock, 09-402

  • Local Institution

    Poznan, Greater Poland Voivodeship, 61-848

  • Local Institution

    Siemianowice Śląskie, 41-100

  • Local Institution

    Torun, 87-100

  • Local Institution

    Warsaw, 01-211

  • Local Institution

    Warsaw, 04-073

  • Local Institution

    Włocławek, 87-800

  • Local Institution

    Wroclaw, 50-315

  • Local Institution

    Wroclaw, 50-981

Other trials in Poland

Russia23 sites

  • Local Institution

    Gatchina, 188300

  • Local Institution

    Kazan', 420103

  • Local Institution

    Krasnodar, 350012

  • Local Institution

    Krasnodar, 350086

  • Local Institution

    Moscow, 111539

  • Local Institution

    Moscow, 117292

  • Local Institution

    Moscow, 121309

  • Local Institution

    Moscow, 121552

  • Local Institution

    Novosibirsk, 630047

  • Local Institution

    Novosibirsk, 630055

  • Local Institution

    Saint Petersburg, 192242

  • Local Institution

    Saint Petersburg, 195067

  • Local Institution

    Saint Petersburg, 195257

  • Local Institution

    Saint Petersburg, 196601

  • Local Institution

    Saint Petersburg, 198013

  • Local Institution

    Saint Petersburg, 199106

  • Local Institution

    Samara, 443070

  • Local Institution

    Saratov, 410028

  • Local Institution

    Saratov, 410054

  • Local Institution

    Sochi, 354057

  • Local Institution

    Tyumen, 625000

  • Local Institution

    Tyumen, 625026

  • Local Institution

    Yekaterinburg, 620026

Other trials in Russia

Ukraine18 sites

  • Local Institution

    Cherkasy, 18009

  • Local Institution

    Chernivtsi, 58013

  • Local Institution

    Dnipropetrovsk, 49006

  • Local Institution

    Ivano-Frankivsk, 76018

  • Local Institution

    Kharkiv, 61058

  • Local Institution

    Kharkiv, 61103

  • Local Institution

    Kharkiv, 61176

  • Local Institution

    Kyiv, 02091

  • Local Institution

    Kyiv, 03049

  • Local Institution

    Kyiv, 03680

  • Local Institution

    Lutsk, 43005

  • Local Institution

    Lutsk, 43024

  • Local Institution

    Mykolaiv, 54003

  • Local Institution

    Odesa, 65014

  • Local Institution

    Uzhhorod, 88014

  • Local Institution

    Vinnytsia, 21005

  • Local Institution

    Vinnytsia, 21029

  • Local Institution

    Zhaporizhzhya, 69000

Other trials in Ukraine

Bulgaria17 sites

  • Local Institution

    Burgas, 8000

  • Local Institution

    Dimitrovgrad, 6400

  • Local Institution

    Haskovo, 6300

  • Local Institution

    Montana, 3400

  • Local Institution

    Pazardzhik, 4400

  • Local Institution

    Pleven, 5800

  • Local Institution

    Plovdiv, 4002

  • Local Institution

    Sandanski, 2800

  • Local Institution

    Smolyan, 4700

  • Local Institution

    Sofia, 1202

  • Local Institution

    Sofia, 1407

  • Local Institution

    Sofia, 1431

  • Local Institution

    Sofia, 1505

  • Local Institution

    Sofia, 1527

  • Local Institution

    Sofia, 1606

  • Local Institution

    Veliko Tarnova, 5000

  • Local Institution

    Vidin, 3700

Other trials in Bulgaria

Hungary15 sites

  • Local Institution

    Baja, Bács-Kiskun county, 6500

  • Local Institution

    Békéscsaba, 5900

  • Local Institution

    Budapest, 1027

  • Local Institution

    Budapest, 1087

  • Local Institution

    Budapest, 1096

  • Local Institution

    Budapest, 1097

  • Local Institution

    Budapest, 1125

  • Local Institution

    Budapest, 1134

  • Local Institution

    Keszthely, 08360

  • Local Institution

    Mosonmagyaróvár, 9200

  • Local Institution

    Pécs, 7623

  • Local Institution

    Pécs, 7624

  • Local Institution

    Szeged, 6725

  • Local Institution

    Szekszárd, 7100

  • Local Institution

    Szolnok, 5004

Other trials in Hungary

Romania15 sites

  • Local Institution

    Baia Mare, 430031

  • Local Institution

    Brasov, 500326

  • Local Institution

    Bucharest, 022328

  • Local Institution

    Bucharest, 050098

  • Local Institution

    Cluj-Napoca, 400006

  • Local Institution

    Cluj-Napoca, 400347

  • Local Institution

    Craiova, 200642

  • Local Institution

    Oradea, 410169

  • Local Institution

    Piteşti, 110283

  • Local Institution

    Sibiu, 550172

  • Local Institution

    Targoviste, 130095

  • Local Institution

    Târgu Mureş, 540042

  • Local Institution

    Târgu Mureş, 540136

  • Local Institution

    Timișoara, 300079

  • Local Institution

    Timișoara, 300310

Other trials in Romania

Spain15 sites

  • Local Institution

    Alicante, ?03010

  • Local Institution

    Barcelona, 08036

  • Local Institution

    Córdoba, 14004

  • Local Institution

    Donostia / San Sebastian, 20080

  • Local Institution

    Huelva, 21005

  • Local Institution

    Madrid, 28007

  • Local Institution

    Madrid, 28031

  • Local Institution

    Madrid, 28034

  • Local Institution

    Madrid, 28040

  • Local Institution

    Majadahonda, Madrid, 28222

  • Local Institution

    Málaga, 29010

  • Local Institution

    Marbella, 29603

  • Local Institution

    Palma de Mallorca, 07198

  • Local Institution

    Valencia, 46010

  • Local Institution

    Valencia, 46014

Other trials in Spain

Israel14 sites

  • Local Institution

    Afula, 18101

  • Local Institution

    Ashkelon, 78278

  • Local Institution

    Hadera, 38100

  • Local Institution

    Haifa, 31048

  • Local Institution

    Haifa, 31096

  • Local Institution

    Haifa, 34361

  • Local Institution

    Herzliya, 46851

  • Local Institution

    Holon, 58100

  • Local Institution

    Jerusalem, 91240

  • Local Institution

    Ramat Gan, 52621

  • Local Institution

    Rehovot, 76100

  • Local Institution

    Safed, 13100

  • Local Institution

    Tel Aviv, 64239

  • Local Institution

    Tiberias, 15208

Other trials in Israel

Mexico14 sites

  • Local Institution

    Aguascalientes, 20230

  • Local Institution

    Culiacán, Sinaloa, 80230

  • Local Institution

    Durango, 34080

  • Local Institution

    Guadalajara, Jalisco, 44340

  • Local Institution

    León, Guanajuato, 37150

  • Local Institution

    Monterrey, Nuevo León, 64000

  • Local Institution

    Puebla City, 72197

  • Local Institution

    Querétaro City, Querétaro, 76000

  • Local Institution

    San Juan del Río, Querétaro, 76800

  • Local Institution

    San Luis Potosí City, 78200

  • Local Institution

    San Luis Potosí City

  • Local Institution

    Tlalnepantla, 54055

  • Local Institution

    Torreón, Coahuila, 27000

  • Local Institution

    Veracruz, 91910

Other trials in Mexico

Croatia13 sites

  • Local Institution

    Čakovec, 40000

  • Local Institution

    Dubrovnik, 20000

  • Local Institution

    Karlovac, 47000

  • Local Institution

    Krapinske Toplice, 49217

  • Local Institution

    Opatija, 51410

  • Local Institution

    Osijek, 31000

  • Local Institution

    Rijeka, 51000

  • Local Institution

    Šibenik, 22000

  • Local Institution

    Slavonski Brod, 35000

  • Local Institution

    Virovitica, 33000

  • Local Institution

    Zabok, 49210

  • Local Institution

    Zadar, 23000

  • Local Institution

    Zagreb, 10000

Other trials in Croatia

India13 sites

  • Local Institution

    Ahmedabad, Gujarat, 380060

  • Local Institution

    Amritsar, 143004

  • Local Institution

    Bangalore, Karnataka, 560034

  • Local Institution

    Jaipur, 302020

  • Local Institution

    Lucknow, 226003

  • Local Institution

    Madurai, 625107

  • Local Institution

    Mangalore, 575002

  • Local Institution

    New Delhi, 110025

  • Local Institution

    New Delhi, 110060

  • Local Institution

    Noida, 201301

  • Local Institution

    Shivamogga, 577205

  • Local Institution

    Vadodara, 390015

  • Local Institution

    Vijayawada, 520008

Other trials in India

Netherlands12 sites

  • Local Institution

    Amsterdam, 1034 CS

  • Local Institution

    Amsterdam, 1061 AE

  • Local Institution

    Arnhem, 6815 AD

  • Local Institution

    Breda, 4819 EV

  • Local Institution

    Ede, 6716 RP

  • Local Institution

    Groningen, 9728NT

  • Local Institution

    Hardenberg, 7772 SE

  • Local Institution

    Maastricht, 6211 LK

  • Local Institution

    Nieuwegein, 3435 CM

  • Local Institution

    Rotterdam, 3045 PM

  • Local Institution

    Tilburg, 5042 AD

  • Local Institution

    Uden, 5406 PT

Other trials in Netherlands

Slovakia12 sites

  • Local Institution

    Banská Bystrica, 974 01

  • Local Institution

    Bardejov, 085 01

  • Local Institution

    Bratislava, 813 69

  • Local Institution

    Bratislava, 833 48

  • Local Institution

    Brezno, 977 42

  • Local Institution

    Košice, 040 01

  • Local Institution

    Košice, 040 11

  • Local Institution

    Košice, 040 22

  • Local Institution

    Nitra, 950 01

  • Local Institution

    Spišská Nová Ves, 052 01

  • Local Institution

    Trebišov, 075 01

  • Local Institution

    Trenčín, 911 01

Other trials in Slovakia

South Korea12 sites

  • Local Institution

    Busan, 49241

  • Local Institution

    Changwon, 51353

  • Local Institution

    Daegu, 41931

  • Local Institution

    Daegu, 42415

  • Local Institution

    Daejeon, 35015

  • Local Institution

    Gwangju, 501-757

  • Local Institution

    Incheon, 21431

  • Local Institution

    Seongnam-si, 13620

  • Local Institution

    Seoul, 03080

  • Local Institution

    Seoul, 08308

  • Local Institution

    Seoul, 130-710

  • Local Institution

    Seoul, 138736

Other trials in South Korea

Denmark11 sites

  • Local Institution

    Aabenraa, 6200

  • Local Institution

    Aarhus, 8000

  • Local Institution

    Copenhagen, DK-2300

  • Local Institution

    Frederiksburg, 2000

  • Local Institution

    Hellerup, DK-2900

  • Local Institution

    Hillerød, DK-3400

  • Local Institution

    Holb?k, DK-4300

  • Local Institution

    Hvidovre, DK-2650

  • Local Institution

    Randers, 8900

  • Local Institution

    Roskilde, DK-4000

  • Local Institution

    Slagelse, DK-4200

Other trials in Denmark

United Kingdom11 sites

  • Local Institution

    Birmingham, B18 7QH

  • Local Institution

    Bournemouth, Dorset, BH7 7DW

  • Local Institution

    Doncaster, South Yorkshire, DN2 5LT

  • Local Institution

    Dudley, West Midlands, DY1 2HQ

  • Local Institution

    Dundee, DD1 9SY

  • Local Institution

    Kirkcaldy, FIFE, KY2 5AH

  • Local Institution

    Liverpool, Merseyside, L14 3PE

  • Local Institution

    Northampton, Northamptonshire, NN1 5BD

  • Local Institution

    Sheffield, South Yorkshire, S5 7AU

  • Local Institution

    Stevenage, Hertfordshire, SG1 4AB

  • Local Institution

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Belgium10 sites

  • Local Institution

    Aalst, 9300

  • Local Institution

    Antwerp, 2020

  • Local Institution

    Bonheiden, 2820

  • Local Institution

    Brasschaat, 2930

  • Local Institution

    Brussels, 1000

  • Local Institution

    Ghent, 9000

  • Local Institution

    Ieper, 8900

  • Local Institution

    Leuven, 3000

  • Local Institution

    Wilrijk, 2610

  • Local Institution

    Yvoir, 5530

Other trials in Belgium

France10 sites

  • Local Institution

    Besançon, 25000

  • Local Institution

    Caen, 14033

  • Local Institution

    Chambray-lès-Tours, 37170

  • Local Institution

    Le Coudray, 28360

  • Local Institution

    Lyon, 69365

  • Local Institution

    Marseille, 13385

  • Local Institution

    Nîmes, 30029

  • Local Institution

    Pau, 64000

  • Local Institution

    Pessac, 33604

  • Local Institution

    Toulouse, 31059

Other trials in France

Portugal10 sites

  • Local Institution

    Almada, 2801-951

  • Local Institution

    Aveiro, 3814-501

  • Local Institution

    Braga, 4710-243

  • Local Institution

    Coimbra, 3000-075

  • Local Institution

    Covilha, 6200-251

  • Local Institution

    Guimar?es, 4835-044

  • Local Institution

    Leiria, 2410-187

  • Local Institution

    Lisbon, 1649-035

  • Local Institution

    Senhora de Hora, Matosinhos, 4464-513

  • Local Institution

    Vila Real, 5000-508

Other trials in Portugal

Austria7 sites

  • Local Institution

    Graz, 8020

  • Local Institution

    Graz, 8036

  • Local Institution

    Linz, 4010

  • Local Institution

    Linz, 4021

  • Local Institution

    Vienna, 1100

  • Local Institution

    Vienna, 1160

  • Local Institution

    Vienna, A-1090

Other trials in Austria

Sweden7 sites

  • Local Institution

    Eskilstuna, 63188

  • Local Institution

    Gothenburg, 413 45

  • Local Institution

    Jönköping, 551 85

  • Local Institution

    Östersund, SE-83183

  • Local Institution

    Skellefteå, 931 81

  • Local Institution

    Stockholm, 112 81

  • Local Institution

    Uppsala, 755 92

Other trials in Sweden

Colombia6 sites

  • Local Institution

    Barranquilla, 84-176

  • Local Institution

    Barranquilla

  • Local Institution

    Bogotá

  • Local Institution

    Cali, 760032

  • Local Institution

    Espinal

  • Local Institution

    Medellín

Other trials in Colombia

Czechia6 sites

  • Local Institution

    Prague, 128 08

  • Local Institution

    Prague, 150 06

  • Local Institution

    Prague, 180 85

  • Local Institution

    Tábor, 390 03

  • Local Institution

    Ústí nad Orlicí, 562 18

  • Local Institution

    Zlín, 762 75

Other trials in Czechia

Norway6 sites

  • Local Institution

    Bod?, NO-8005

  • Local Institution

    Oslo, 0450

  • Local Institution

    Oslo, NO-370

  • Local Institution

    Skien, N-3710

  • Local Institution

    Stavanger, 4068

  • Local Institution

    Tromsø, 9038

Other trials in Norway

Peru6 sites

  • Local Institution

    Callao, Callao 02

  • Local Institution

    Callao, Callao 2

  • Local Institution

    Cusco, Cusco 84

  • Local Institution

    Lima, Lima 11

  • Local Institution

    Lima, Lima 31

  • Local Institution

    Miraflores, Lima region

Other trials in Peru

Serbia6 sites

  • Local Institution

    Belgarde, 11000

  • Local Institution

    Belgrade, 11000

  • Local Institution

    Belgrade, 11080

  • Local Institution

    Kamenitz, 21204

  • Local Institution

    Niš, 18000

  • Local Institution

    Užice, 31000

Other trials in Serbia

Australia5 sites

  • Local Institution

    Bedford Park, 5024

  • Local Institution

    Concord, New South Wales, 2139

  • Local Institution

    Elizabeth Vale, South Australia, 5112

  • Local Institution

    Milton, Queensland, 4064

  • Local Institution

    Port Macquarie, New South Wales, 2444

Other trials in Australia

Switzerland3 sites

  • Local Institution

    Bern, 3010

  • Local Institution

    Geneva, 1205

  • Local Institution

    Winterthur, 8401

Other trials in Switzerland

Chile1 site

  • Local Institution

    Santiago, Santiago Metropolitan, 7500588

Other trials in Chile

Italy1 site

  • Local Institution

    Grosseto, 58100

Other trials in Italy

Puerto Rico1 site

  • Local Institution

    Caguas, 00725

Other trials in Puerto Rico

Virgin Islands1 site

  • Local Institution

    Christiansted, 00820

About this study

Official title: An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention

The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K antagonist, such as warfarin, with or without aspirin.

Read the detailed description

Patients will be recruited from either inpatient coronary care or general medical units, or recruited from outpatient cardiology offices.

Masking:

Apixaban: Open label.

VKA: Open label.

Acetylsalicylic acid film coated tablet: Double Blinded.

Placebo matching Acetylsalicylic acid film coated tablet: Double Blinded.

Being tested
Apixaban, vitamin K antagonist, Acetylsalicylic acid, Acetylsalicylic acid placebo
Medical subject headings
Acute Coronary Syndrome

What participants receive

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

  • ApixabanDrug

    Also called BMS-562247

  • vitamin K antagonistDrug

  • Acetylsalicylic acidDrug

    Also called Aspirin 81 mg

  • Acetylsalicylic acid placeboOther

    Also called aspirin placebo

Study groups in NCT02415400
Study groupRoleWhat they receive
ApixabanActive comparator5 mg or 2.5 mg Apixaban tablets orally twice per day
Receives: Drug: Apixaban
Vitamin K AntagonistActive comparatorVKA tablets orally once daily
Receives: Drug: vitamin K antagonist
Acetylsalicylic acid film coated tabletPlacebo comparator81 mg Acetylsalicylic acid film coated tablet orally once daily
Receives: Drug: Acetylsalicylic acid
Placebo matching Acetylsalicylic acid film coated tabletPlacebo comparatorPlacebo matching Acetylsalicylic acid film coated tablet once daily
Receives: Other: Acetylsalicylic acid placebo

What is being measured

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

  1. The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period

    Time to first ISTH major or CRNM bleeding during the 6-month period of treatment with Apixaban or VKA.

    N is the number of participants treated with Apixaban or VKA.

    n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment.

    Event rates are calculated based on the number of participants with major or CRNM bleeding divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.

    Measured: Approximately 6 months

  2. The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period

    Time to first ISTH major or CRNM bleeding during the treatment period of 6 months with aspirin or placebo.

    N is the number of participants with aspirin or placebo.

    n is the number of participants treated with aspirin or placebo with major or CRNM bleeding in each treatment group during the 6-month period of treatment.

    Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.

    Measured: Approximately 6 months

Secondary outcomes (5)

  1. Superiority on ISTH Major or CRNM Bleeding for Apixaban Versus VKA

    Time to first occurrence during the time the participants were treated with Apixaban or VKA.

    N is the number of participants treated with Apixaban or VKA.

    n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment.

    Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.

    Measured: Approximately 6 months

  2. The Rate of All-cause Death or All-cause Rehospitalization With Apixaban Versus VKA

    Time to first all-cause death or all-cause hospitalization during the during the 6-month treatment period with Apixaban or VKA.

    N is the number of participants treated with Apixaban or VKA.

    n is the number of participants treated with Apixaban or VKA with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment.

    Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.

    Measured: Approximately 6 months

  3. The Rate of All-cause Death or All-cause Rehospitalization With Aspirn Versus no Aspirin

    Time to first all-cause death or all-cause hospitalization during the 6-month period of treatment with aspirin or placebo.

    N is the number of participants treated with aspirin or placebo.

    n is the number of participants treated with aspirin or placebo with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment.

    Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.

    Measured: Approximately 6 months

  4. The Rate of the Composite Endpoint of Death or Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Apixaban Versus VKA

    Time to first occurrence during the 6-month treatment period with Apixaban or VKA.

    N is the number of participants treated with Apixaban or VKA.

    n is the number of participants treated with Apixaban or VKA with death or ischemic events in each treatment group during the during the 6-month period of treatment.

    Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.

    Measured: Approximately 6 months

  5. The Composite Endpoints of Death and Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Aspirin Versus no Aspirin

    Time to first death or ischenic event during the 6-month treatment period with aspirin or placebo.

    N is the number of participants treated with aspirin or placebo.

    n is the number of participants treated with aspirin or placebo with death or ischemic events in each treatment group during the 6-month treatment period.

    Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.

    Measured: Approximately 6 months

Timeline

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

  1. First posted14 Apr 2015 (estimated)
  2. Study start4 Jun 2015
  3. Primary completion10 Nov 2018
  4. Study completion10 Nov 2018

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
Other
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
4,614 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02415400
Sponsor's protocol ID
CV185-316
Other IDs
2014-002004-24, 2014
Status last verified
Jun 2020
First submitted
9 Apr 2015
Last updated
11 Jun 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Fudim M, Lopes RD, Wojdyla DM, Mehran R, Khan MS, Granger CB, Goodman SG, Aronson R, Windecker S, Alexander JH. Apixaban Dose in Patients With Atrial Fibrillation and Acute Coronary Syndrome and/or Undergoing Percutaneous Coronary Intervention: Insights From AUGUSTUS. JACC Adv. 2025 Apr;4(4):101665. doi: 10.1016/j.jacadv.2025.101665. Epub 2025 Mar 20.

    PubMed 40117694

  • Tannu M, Lopes RD, Wojdyla DM, Goodman SG, Aronson R, Mehran R, Granger CB, Windecker S, Alexander JH, Jones WS. Antithrombotic Therapy to Minimize Total Events After ACS or PCI in Atrial Fibrillation: Insights From AUGUSTUS. J Am Coll Cardiol. 2025 Mar 25;85(11):1157-1168. doi: 10.1016/j.jacc.2024.10.125. Epub 2025 Feb 5.

    PubMed 39918467

  • Fanaroff AC, Vora AN, Wojdyla DM, Mehran R, Granger CB, Goodman SG, Aronson R, Windecker S, Alexander JH, Lopes RD. Effect of apixaban versus vitamin K antagonist and aspirin versus placebo on days alive and out of hospital: An analysis from AUGUSTUS. Am Heart J. 2025 Feb;280:60-69. doi: 10.1016/j.ahj.2024.11.005. Epub 2024 Nov 17.

    PubMed 39557109

  • Fanaroff AC, Wojdyla DM, Granger CB, Goodman SG, Aronson RS, Windecker S, Mehran R, Alexander JH, Lopes RD. Relative Benefit of Dual Versus Single Antiplatelet Therapy Among Patients With Atrial Fibrillation on Oral Anticoagulation According to Time After ACS and PCI: Insights From the AUGUSTUS Trial. Circ Cardiovasc Interv. 2024 Nov;17(11):e013596. doi: 10.1161/CIRCINTERVENTIONS.123.013596. Epub 2024 Nov 6.

    PubMed 39502066

  • Berwanger O, Wojdyla DM, Fanaroff AC, Budaj A, Granger CB, Mehran R, Aronson R, Windecker S, Goodman SG, Alexander JH, Lopes RD. Antithrombotic Strategies in Atrial Fibrillation After ACS and/or PCI: A 4-Way Comparison From AUGUSTUS. J Am Coll Cardiol. 2024 Sep 3;84(10):875-885. doi: 10.1016/j.jacc.2024.06.022.

    PubMed 39197976

  • Guimaraes PO, Lopes RD, Wojdyla DM, Alexander JH, Goodman SG, Aronson R, Halvorsen S, Sinnaeve P, Vinereanu D, Storey RF, Berwanger O, Windecker S, Mehran R, Granger CB, Alexander KP; AUGUSTUS Investigators. Antithrombotic Strategies According to Age: Insights from the AUGUSTUS Trial. Am J Med. 2024 Oct;137(10):958-965. doi: 10.1016/j.amjmed.2024.06.001. Epub 2024 Jun 13.

    PubMed 38876331

  • Bahit MC, Vora AN, Li Z, Wojdyla DM, Thomas L, Goodman SG, Aronson R, Jordan JD, Kolls BJ, Dombrowski KE, Vinereanu D, Halvorsen S, Berwanger O, Windecker S, Mehran R, Granger CB, Alexander JH, Lopes RD. Apixaban or Warfarin and Aspirin or Placebo After Acute Coronary Syndrome or Percutaneous Coronary Intervention in Patients With Atrial Fibrillation and Prior Stroke: A Post Hoc Analysis From the AUGUSTUS Trial. JAMA Cardiol. 2022 Jul 1;7(7):682-689. doi: 10.1001/jamacardio.2022.1166.

    PubMed 35612866

  • Welsh RC, Dehghani P, Lopes R, Wojdyla DM, Aronson R, Granger CB, Windecker S, Vora AN, Vinereanu D, Halvorsen S, Parkhomenko A, Mehran R, Alexander JH, Goodman S. Impact of prior oral anticoagulant use and outcomes on patients from secondary analysis in the AUGUSTUS trial. Open Heart. 2022 Feb;9(1):e001892. doi: 10.1136/openhrt-2021-001892.

    PubMed 35172988

  • Harskamp RE, Fanaroff AC, Lopes RD, Wojdyla DM, Goodman SG, Thomas LE, Aronson R, Windecker S, Mehran R, Granger CB, Alexander JH. Antithrombotic Therapy in Patients With Atrial Fibrillation After Acute Coronary Syndromes or Percutaneous Intervention. J Am Coll Cardiol. 2022 Feb 8;79(5):417-427. doi: 10.1016/j.jacc.2021.11.035.

    PubMed 35115097

  • Hijazi Z, Alexander JH, Li Z, Wojdyla DM, Mehran R, Granger CB, Parkhomenko A, Bahit MC, Windecker S, Aronson R, Berwanger O, Halvorsen S, de Waha-Thiele S, Sinnaeve P, Darius H, Storey RF, Lopes RD. Apixaban or Vitamin K Antagonists and Aspirin or Placebo According to Kidney Function in Patients With Atrial Fibrillation After Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial. Circulation. 2021 Mar 23;143(12):1215-1223. doi: 10.1161/CIRCULATIONAHA.120.051020. Epub 2021 Jan 19.

    PubMed 33461308

  • Alexander JH, Wojdyla D, Vora AN, Thomas L, Granger CB, Goodman SG, Aronson R, Windecker S, Mehran R, Lopes RD. Risk/Benefit Tradeoff of Antithrombotic Therapy in Patients With Atrial Fibrillation Early and Late After an Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From AUGUSTUS. Circulation. 2020 May 19;141(20):1618-1627. doi: 10.1161/CIRCULATIONAHA.120.046534. Epub 2020 Mar 29.

    PubMed 32223444

  • Lopes RD, Leonardi S, Wojdyla DM, Vora AN, Thomas L, Storey RF, Vinereanu D, Granger CB, Goodman SG, Aronson R, Windecker S, Thiele H, Valgimigli M, Mehran R, Alexander JH. Stent Thrombosis in Patients With Atrial Fibrillation Undergoing Coronary Stenting in the AUGUSTUS Trial. Circulation. 2020 Mar 3;141(9):781-783. doi: 10.1161/CIRCULATIONAHA.119.044584. Epub 2019 Nov 11. No abstract available.

    PubMed 31707833

  • Windecker S, Lopes RD, Massaro T, Jones-Burton C, Granger CB, Aronson R, Heizer G, Goodman SG, Darius H, Jones WS, Aschermann M, Brieger D, Cura F, Engstrom T, Fridrich V, Halvorsen S, Huber K, Kang HJ, Leiva-Pons JL, Lewis BS, Malaga G, Meneveau N, Merkely B, Milicic D, Morais J, Potpara TS, Raev D, Sabate M, de Waha-Thiele S, Welsh RC, Xavier D, Mehran R, Alexander JH; AUGUSTUS Investigators. Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial. Circulation. 2019 Dec 3;140(23):1921-1932. doi: 10.1161/CIRCULATIONAHA.119.043308. Epub 2019 Sep 26.

    PubMed 31557056

  • Lopes RD, Heizer G, Aronson R, Vora AN, Massaro T, Mehran R, Goodman SG, Windecker S, Darius H, Li J, Averkov O, Bahit MC, Berwanger O, Budaj A, Hijazi Z, Parkhomenko A, Sinnaeve P, Storey RF, Thiele H, Vinereanu D, Granger CB, Alexander JH; AUGUSTUS Investigators. Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation. N Engl J Med. 2019 Apr 18;380(16):1509-1524. doi: 10.1056/NEJMoa1817083. Epub 2019 Mar 17.

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  • Lopes RD, Vora AN, Liaw D, Granger CB, Darius H, Goodman SG, Mehran R, Windecker S, Alexander JH. An open-Label, 2 x 2 factorial, randomized controlled trial to evaluate the safety of apixaban vs. vitamin K antagonist and aspirin vs. placebo in patients with atrial fibrillation and acute coronary syndrome and/or percutaneous coronary intervention: Rationale and design of the AUGUSTUS trial. Am Heart J. 2018 Jun;200:17-23. doi: 10.1016/j.ahj.2018.03.001. Epub 2018 Mar 9.

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Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Apixaban, vitamin K antagonist and Acetylsalicylic acid in people with Acute Coronary Syndromes, run by Bristol-Myers Squibb at 626 sites in 37 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 4 inclusion and 6 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 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 626 sites in United States, Germany, Argentina, Brazil, Canada and 32 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. Some participants in this study may receive a placebo. 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 7 Feb 2020). 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?

The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period (time frame: Approximately 6 months). The study lists 2 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 NCT02415400, which also lists 15 linked publications.

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 11 Jun 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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