Should heart bypass patients get blood thinners for new atrial fibrillation? major trial aims to find out

NCT ID NCT04045665

Disease control Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether adding a blood thinner to standard antiplatelet therapy helps prevent strokes and blood clots in people who develop a new, temporary irregular heartbeat after coronary artery bypass surgery. About 3,200 adults who had bypass surgery and then experienced atrial fibrillation will be randomly assigned to receive either antiplatelet drugs alone or antiplatelet drugs plus a blood thinner. The goal is to balance preventing clots against the risk of major bleeding.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Blood thinners (anticoagulants like warfarin or apixaban) plus antiplatelet drugs (aspirin or clopidogrel)
What this could lead to: If it works, this could show that adding blood thinners after heart bypass surgery reduces the risk of stroke or blood clots in patients who develop temporary atrial fibrillation.
What could go wrong: This is a large phase 3 trial, but it is still ongoing and results are not yet known. Adding blood thinners may increase the risk of serious bleeding, and the benefit may not outweigh the risk for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 3,200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2019

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients of age ≥18 years who undergo isolated CABG for coronary artery disease * POAF that persists for \>60 minutes or is recurrent (more than one episode) within 7 days after the index CABG surgery Exclusion Criteria: * Clinical history of either permanent, persistent or paroxysmal atrial fibrillation * Any pre-existing clinical indication for long-term OAC * Any absolute contraindication to OAC * Planned use of post-operative dual antiplatelet therapy (DAPT) a. This includes, but is not limited to, patients with recent PCI with drug-eluting or bare-metal stent. * Cardiogenic shock * Major perioperative complication\* occurring between CABG and randomization a. including, but not limited to, stroke, TIA, MI, major bleeding (BARC type 4 bleeding), severe sepsis, renal failure requiring dialysis, or need for reoperation due to bleeding (e.g. pericardial tamponade). * Concomitant left atrial appendage closure during CABG * Concomitant valve surgery during CABG or prior valve surgery (including aortic, mitral, tricuspid or pulmonary) * Concomitant mitral valve annuloplasty during CABG * Concomitant carotid artery endarterectomy during CABG * Concomitant aortic root replacement during CABG * Concomitant surgery for AF during CABG * Liver cirrhosis or Child-Pugh Class C chronic liver disease * Pharmacologic therapy with an investigational drug or device within 30-days prior to randomization or plan to enroll patient in an investigational drug or device trial during participation in this trial * Pregnancy at the time of randomization * Unable or unwilling to provide inform consent * Unable or unwilling to comply with the study treatment and follow-up * Existence of underlying disease that limits life expectancy to less than one year

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Conditions

The condition(s) this trial relates to.

atrial fibrillation Hemorrhage hemorrhagic disease stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation Bleeding Stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

78 sites in 4 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Allegheny Health Network
ACTIVE_NOT_RECRUITING

Pittsburgh, Pennsylvania, 15212, United States
Ascension St. John
ACTIVE_NOT_RECRUITING

Tulsa, Oklahoma, 74103, United States
Ascension St. Vincent
ACTIVE_NOT_RECRUITING

Indianapolis, Indiana, 46260, United States
Barts Health NHS Trust
RECRUITING

London, England, United Kingdom
Baylor College of Medicine
RECRUITING

Houston, Texas, 77030, United States
Baylor Research Institute
RECRUITING

Plano, Texas, 75093, United States
Baystate Health
ACTIVE_NOT_RECRUITING

Springfield, Massachusetts, 01199, United States
Belfast Health and Social Care Trust
ACTIVE_NOT_RECRUITING

Belfast, Northern Ireland, United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust
RECRUITING

Blackpool, United Kingdom
Boston Medical Center
ACTIVE_NOT_RECRUITING

Boston, Massachusetts, 02118, United States
Brigham and Women's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
CHI St. Vincent, Arkansas
RECRUITING

Little Rock, Arkansas, 72205, United States
Cedars-Sinai Medical Center
RECRUITING

Los Angeles, California, 90048, United States
Centre Hospitalier de l'Université de Montréal
RECRUITING

Montreal, Quebec, H2W 1T8, Canada
Charité Berlin - Benjamin Franklin Campus
NOT_YET_RECRUITING

Berlin, Germany
Charité Berlin - Rudolf Virchow Campus
NOT_YET_RECRUITING

Berlin, Germany
Cleveland Clinic Foundation
RECRUITING

Cleveland, Ohio, 44195, United States
Clinic Bad Neustadt - Medical Center for Heart and Vascular Diseases
NOT_YET_RECRUITING

Bad Neustadt an der Saale, Germany
Columbia University Medical Center
RECRUITING

New York, New York, 10032, United States
Dartmouth-Hitchcock Medical Center
RECRUITING

Lebanon, New Hampshire, 03766, United States
Duke University
RECRUITING

Durham, North Carolina, 27710, United States
East Carolina University
RECRUITING

Greenville, North Carolina, 27858, United States
Emory University
RECRUITING

Atlanta, Georgia, 30308, United States
Frankfurt University Hospital
RECRUITING

Frankfurt, Germany
German Heart Center Berlin
RECRUITING

Berlin, Germany
German Heart Center Munich
NOT_YET_RECRUITING

Munich, Germany
HDZ-NRW Bad Oeynhausen
NOT_YET_RECRUITING

Bad Oeynhausen, Germany
Heart Center Leipzig
RECRUITING

Berlin, Brandenburg, 13347, Germany
Heart Center, University of Freiburg
RECRUITING

Freiburg im Breisgau, Germany
Heinrich Heine University Düsseldorf
RECRUITING

Düsseldorf, Germany
Hospital Samaritano Paulista
ACTIVE_NOT_RECRUITING

São Paulo, Brazil
Hospital Universitário São Francisco na Providência de Deus
ACTIVE_NOT_RECRUITING

São Paulo, Brazil
Hospital of the Brothers of Mercy Trier
RECRUITING

Trier, Germany
Hull University Teaching Hospitals NHS Trust
ACTIVE_NOT_RECRUITING

Cottingham, HU16 5JQ, United Kingdom
Hôpital Laval
RECRUITING

Québec, G1V 4G5, Canada
Hôpital du Sacré-Cœur de Montréal
WITHDRAWN

Montreal, Quebec, H4J 1C5, Canada
Imperial College Healthcare NHS Trust
RECRUITING

London, England, United Kingdom
Indiana University
ACTIVE_NOT_RECRUITING

Indianapolis, Indiana, 46202, United States
Inova Health
ACTIVE_NOT_RECRUITING

Falls Church, Virginia, 22042, United States
Instituto de Pesquisa Clínica de Campinas
ACTIVE_NOT_RECRUITING

São Paulo, Brazil
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP-InCor-HCFMUSP
ACTIVE_NOT_RECRUITING

São Paulo, Brazil
Intermountain CV Research
RECRUITING

Murray, Utah, 84107, United States
Jersey Shore University Medical Center
RECRUITING

Neptune City, New Jersey, 07753, United States
Johns Hopkins
RECRUITING

Baltimore, Maryland, 21287, United States
Kerckhoff Klinik, Bad Nauheim
RECRUITING

Bad Nauheim, Germany
Liverpool Heart and Chest Hospital NHS Foundation Trust
RECRUITING

Liverpool, England, United Kingdom
London Health Sciences Centre
RECRUITING

London, Ontario, N6A 5A5, Canada
Lutheran Medical Center
ACTIVE_NOT_RECRUITING

Fort Wayne, Indiana, 46825, United States
Maine Medical Center
RECRUITING

Portland, Maine, 04102, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Mayo Clinic
RECRUITING

Rochester, Minnesota, 55905, United States
MedStar Washington Hospital Center
RECRUITING

Washington D.C., District of Columbia, 20010, United States
Medical Center Braunschweig
NOT_YET_RECRUITING

Braunschweig, Germany
Medical Center of Aurora
ACTIVE_NOT_RECRUITING

Aurora, Colorado, 80012, United States
Medical Center of the Ludwig-Maximilians-University Munich
NOT_YET_RECRUITING

Munich, Germany
Michael E. DeBakey VA Medical Center
RECRUITING

Houston, Texas, 77030, United States
Mid America Health Institute
RECRUITING

Kansas City, Missouri, 64111, United States
Montefiore Medical Center
RECRUITING

The Bronx, New York, 10467, United States
Montreal Heart Institute
RECRUITING

Montreal, Quebec, H1T 1C8, Canada
Northwell Health System
RECRUITING

Great Neck, New York, 11023, United States
Nottingham University Hospitals NHS Trust
RECRUITING

Nottingham, United Kingdom
Ochsner Clinic
RECRUITING

New Orleans, Louisiana, 70121, United States
Ohio State University Medical Center
ACTIVE_NOT_RECRUITING

Columbus, Ohio, 43210, United States
Oxford University Hospitals NHS Foundation Trust
ACTIVE_NOT_RECRUITING

Oxford, OX3 9DU, United Kingdom
Piedmont Healthcare Inc.
RECRUITING

Atlanta, Georgia, 30309, United States
Royal Papworth Hospital NHS Foundation Trust
ACTIVE_NOT_RECRUITING

Cambridge, United Kingdom
Royal Wolverhampton NHS Trust
RECRUITING

Wolverhampton, England, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
ACTIVE_NOT_RECRUITING

Sheffield, United Kingdom
South Tees Hospitals NHS Foundation Trust
RECRUITING

Middlesbrough, United Kingdom
Stanford University
RECRUITING

Stanford, California, 94305, United States
Suburban Hospital
ACTIVE_NOT_RECRUITING

Bethesda, Maryland, 20814, United States
Sunnybrook Hospital
RECRUITING

Toronto, Ontario, M4N 3M5, Canada
The Mount Sinai Hospital
WITHDRAWN

New York, New York, 10029, United States
Toronto General Hospital
NOT_YET_RECRUITING

Toronto, Canada
University Heart Center Hamburg
NOT_YET_RECRUITING

Berlin, Brandenburg, 11353, Germany
University Hospital Bonn
RECRUITING

Bonn, Germany
University Hospital Magdeburg
RECRUITING

Magdeburg, Germany
University Hospital Southampton NHS Foundation Trust
RECRUITING

Southampton, United Kingdom
University Hospitals Bristol NHS Foundation Trust
RECRUITING

Bristol, BS1 3NU, United Kingdom
University Hospitals Plymouth NHS Trust
ACTIVE_NOT_RECRUITING

Plymouth, United Kingdom
University Hospitals Sussex NHS Foundation Trust
RECRUITING

Worthing, BN11 2DH, United Kingdom
University Hospitals of Leicester NHS Trust
ACTIVE_NOT_RECRUITING

Leicester, United Kingdom
University Medical Center Frankfurt
NOT_YET_RECRUITING

Frankfurt, Germany
University Medical Center Göttingen
NOT_YET_RECRUITING

Göttingen, Lower Saxony, Germany
University Medical Center Halle
RECRUITING

Halle, Germany
University Medical Center Heidelberg
NOT_YET_RECRUITING

Heidelberg, Germany
University Medical Center Jena
RECRUITING

Jena, Thuringia, Germany
University Medical Center Schleswig-Holstein Kiel
NOT_YET_RECRUITING

Kiel, Germany
University Medical Center Schleswig-Holstein Lübeck
NOT_YET_RECRUITING

Lübeck, Germany
University of Alberta Hospital
RECRUITING

Edmonton, Alberta, T6G2B7, Canada
University of Maryland
RECRUITING

Baltimore, Maryland, 21201, United States
University of Michigan
RECRUITING

Ann Arbor, Michigan, 48109, United States
University of Oldenburg
RECRUITING

Oldenburg, Germany
University of Ottawa Heart Institute
NOT_YET_RECRUITING

Ottawa, Canada
University of Pennsylvania
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
WITHDRAWN

Hermitage, Pennsylvania, 16148, United States
University of Southern California
RECRUITING

Los Angeles, California, 90033, United States
University of Utah
RECRUITING

Salt Lake City, Utah, 84112, United States
University of Vermont
RECRUITING

Burlington, Vermont, 05401, United States
University of Virginia Health System
RECRUITING

Charlottesville, Virginia, 22908, United States
University of Wisconsin
ACTIVE_NOT_RECRUITING

Madison, Wisconsin, 53792, United States
WakeMed
WITHDRAWN

Raleigh, North Carolina, 27610, United States
Washington University School of Medicine
RECRUITING

St Louis, Missouri, 63110, United States
West Virginia University
RECRUITING

Morgantown, West Virginia, 26506, United States
Western Connecticut Hospital Systems
ACTIVE_NOT_RECRUITING

Danbury, Connecticut, 06810, United States
Yale Medicine
RECRUITING

New Haven, Connecticut, 06520-8039, United States

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