Recruiting
Phase 3

Anticoagulation

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT04045665

Conditions

Atrial Fibrillation

Stroke

Bleeding

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Antiplatelet-only strategy

Oral Anticoagulant plus background antiplatelet therapy

Study Details

Brief summary:

The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery.

All patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey.

Conditions

Atrial Fibrillation

Stroke

Bleeding

Study ID

NCT04045665

Start date

Dec 13, 2019

Status verified date

Jun, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

3200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Antiplatelet Therapy

Antiplatelet-only strategy

active comparator: Oral Anticoagulant

OAC-based strategy

Interventions

Antiplatelet-only strategy

Aspirin 75-325 mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)

Oral Anticoagulant plus background antiplatelet therapy

OAC with vitamin K antagonist (VKA) with international normalized ratio (INR) target 2-3 or any approved direct oral anticoagulant OR apixaban, rivaroxaban, edoxaban or dabigatran) in addition to background antiplatelet therapy with aspirin 75-325mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)

Primary outcome measure

  • Composite of death, ischemic stroke, TIA, MI, systemic arterial thromboembolism or venous thromboembolism (DVT and/or PE) [ Time Frame: up to 180 days after randomization ]
  • Any BARC type 3 or 5 [ Time Frame: 90 days after randomization ]

Central Contacts and Locations

Central contacts

Jonathan Hupf

(212) 659-6862Jonathan.Hupf@mountsinai.org

Locations

CHI St. Vincent, Arkansas

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Lynn Bass

lynn.bass@commonspirit.org

Principal Investigator:

Thurston Bauer

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Ed Lozano

edwardlo@med.usc.edu

Principal Investigator:

Vaughn Starnes, MD

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Vanessa Wilson

Vanessa.Wilson@cshs.org

Principal Investigator:

Joanna Chikwe, MD

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Tiffany Flores

tflores2@stanford.edu

Principal Investigator:

Jack Boyd

Yale Medicine

Recruiting

New Haven, Connecticut, United States, 06520-8039

Contacts

Fadi Al-Daoud

fadi.aldaoud@yale.edu

Margaret Leiss

Margaret.leiss@yale.edu

Principal Investigator:

Matthew Williams, MD

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Katharine Mahoney

Katharine.E.Mahoney@medstar.net

Principal Investigator:

Christian Shults, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Mary McBride

mary.mcbride@emory.edu

Principal Investigator:

Michael Halkos

Piedmont Healthcare Inc.

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Amy Autry-Bush

Amy.Autry-Bush@piedmont.org

Principal Investigator:

Vinod Thourani, MD

Ochsner Clinic

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Nicolle Scholl

nicolle.scholl@ochsner.org

Principal Investigator:

P. Eugene Parrino

Maine Medical Center

Recruiting

Portland, Maine, United States, 04102

Contacts

Monica Palmeri

Monica.Palmeri@mainehealth.org)

Principal Investigator:

Ansar Hassan

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Kaitlyn Masih

KMasih@som.umaryland.edu

Principal Investigator:

Howard Massey, MD

Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Zyriah Robinson

zyriah.robinson@jhmi.edu

Principal Investigator:

Hamza Aziz

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Anna Demelo

amdemelo@mgh.harvard.edu

Principal Investigator:

David D'Alessandro

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Amarri Harrison

aharrison7@bwh.harvard.edu

Principal Investigator:

Sary Aranki

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

China Green

chjgreen@med.umich.edu

Principal Investigator:

Jonathan Haft, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Jennifer Martin

Martin.Jennifer2@mayo.edu

Principal Investigator:

Paul Tang

Mid America Health Institute

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Rosann M Gans

rgans@saint-lukes.org

Principal Investigator:

Keith Allen

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

James Hermeyer

hermeyer.j@wustl.edu

Principal Investigator:

Tsuyoshi Kaneko, MD

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03766

Contacts

Pauline Sirrell

Pauline.Sirrell@hitchcock.org

Principal Investigator:

Henry Tannous

Jersey Shore University Medical Center

Recruiting

Neptune City, New Jersey, United States, 07753

Contacts

Annemarie Detoro

annemarie.detoro@hmhn.org

Principal Investigator:

Kourosh Asgarian, DO

Northwell Health System

Recruiting

Great Neck, New York, United States, 11023

Contacts

Effe Mihelis

emihelis@northwell.edu

Principal Investigator:

Nirav Patel

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Amanda Alonso

aa2974@cumc.columbia.edu

Principal Investigator:

Michael Argenziano

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Magdalena Mamczur-Madry, RN, BSN, MS, ACRP-CP

mmamczur@montefiore.org

Principal Investigator:

Daniel Goldstein, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Shelly Fincannon

shelly.fincannon@duke.edu

Principal Investigator:

Brittany Zwischenberger, MD

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27858

Contacts

Eddie Hill

hille19@ecu.edu

Principal Investigator:

Shahab A. Akhter

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Anna Marie Simmons

SIMMONA8@ccf.org

Principal Investigator:

A Marc Gillinov

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Mary Lou Mayer

MaryLou.Mayer@uphs.upenn.edu

Principal Investigator:

Michael Acker

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Ricardo A Garnica

Ricardo.AvendanoGarnica@bcm.edu

Principal Investigator:

Todd Rosengart

Michael E. DeBakey VA Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Pawel Kolodziejski

Pawel.Kolodziejski@va.gov

Principal Investigator:

Lorraine Cornwell

Baylor Research Institute

Recruiting

Plano, Texas, United States, 75093

Contacts

Kristen Chionh

Kristen.Chionh@BSWHealth.org

Principal Investigator:

Michael DiMaio, MD

Intermountain CV Research

Recruiting

Murray, Utah, United States, 84107

Contacts

Erika Hummel

erika.hummel@imail.org

Principal Investigator:

Stephen McKellar, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Ashley Elmer

Ashley.Elmer@hsc.utah.edu

Principal Investigator:

Craig Selzman

University of Vermont

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Fuyuki Hirashima

Fuyuki.Hirashima@uvmhealth.org

Amy Henderson

Amy.Henderson@uvmhealth.org

Principal Investigator:

Fuyuki Hirashima

University of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Robin Kelly

RLK5A@hscmail.mcc.virginia.edu)

Principal Investigator:

Adanna Akujuo

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Kimberly Quedado

kq10006@wvumedicine.org

Principal Investigator:

Vinay Badhwar

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G2B7

Contacts

Tracy Jordan

Tracy.Jordan@albertahealthservices.ca

Celine Balay

cbalay@ualberta.ca

Principal Investigator:

Steven Meyer, MD

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Stephanie Fox

Stephanie.Fox@lhsc.on.ca

Principal Investigator:

Michael Chu

Sunnybrook Hospital

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Reena Karkhanis

Reena.Karkhanis@sunnybrook.ca

Principal Investigator:

Stephen Fremes

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T 1C8

Contacts

Alexandre Bergeron

alexandre.bergeron.Icm@icm-mhi.org

Principal Investigator:

Denis Bouchard, MD

Centre Hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2W 1T8

Contacts

Joannie Dionne

joannie.dionne.chum@ssss.gouv.qc.ca

Principal Investigator:

Nicolas Noiseux

Hôpital Laval

Recruiting

Québec, Canada, G1V 4G5

Contacts

François Dagenais

francois.dagenais@fmed.ulaval.ca

Nathalie Gagne

Nathalie.Gagne@criucpq.ulaval.ca

Principal Investigator:

Charles Laurin

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • Anticoagulation
  • Antiplatelet Therapy
  • Post Operative Atrial Fibrillation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-06-26.