Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
NCT ID: NCT04045665
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
3200 participants
INTERVENTIONAL
2019-12-13
2026-08-31
Brief Summary
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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.
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Detailed Description
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Patients will be randomly assigned to the following treatment strategies:
* OAC-based strategy (experimental arm): OAC with vitamin K antagonist (VKA) with international normalized ratio (INR) target 2-3 or any approved direct oral anticoagulant (apixaban, rivaroxaban, edoxaban or dabigatran) in addition to background antiplatelet therapy with aspirin 75-325mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)
* Antiplatelet-only strategy (control arm): single antiplatelet therapy with aspirin 75-325mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)
The protocol-specified duration of anticoagulation is 90 days. Patients, who are randomized to the control arm and develop recurrent AF after 30 days, may be crossed-over to an OAC. Accrual is expected to take 60 months. Study follow-up visits will be performed at 90 days and phone follow-up at days 30, 60, and 180 days.
Data for patients enrolled in the registry will be ascertained from the local clinical site via a review of medical records. The baseline risk profile of registry patients (i.e., patients eligible but unwilling to be randomized) will be analyzed and compared to that of patients randomized in the trial. The usage of anticoagulant and antiplatelet therapies in the registry population overall and baseline CHA2DS2-VASC ischemic stroke risk score will also be determined.
Up to 500 patients will also be offered the option to participate in a digital health substudy which includes a wearable heart rhythm monitor device for 30 days post discharge.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Antiplatelet Therapy
Antiplatelet-only strategy
Antiplatelet-only strategy
Aspirin 75-325 mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)
Oral Anticoagulant
OAC-based strategy
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* POAF that persists for \>60 minutes or is recurrent (more than one episode) within 7 days after the index CABG surgery
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Vanderbilt University Medical Center
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Annetine Gelijns
Chair, Department of Population Health Science & Policy Edmond A. Guggenheim Professor of Health Policy Co-Director, InCHOIR
Principal Investigators
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Annetine C Gelijns, PhD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Marc Gillinov, MD
Role: STUDY_DIRECTOR
The Cleveland Clinic
John Alexander, MD
Role: STUDY_DIRECTOR
Duke University
Locations
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CHI St. Vincent, Arkansas
Little Rock, Arkansas, United States
University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford University
Stanford, California, United States
Medical Center of Aurora
Aurora, Colorado, United States
Western Connecticut Hospital Systems
Danbury, Connecticut, United States
Yale Medicine
New Haven, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
Piedmont Healthcare Inc.
Atlanta, Georgia, United States
Lutheran Medical Center
Fort Wayne, Indiana, United States
Indiana University
Indianapolis, Indiana, United States
Ascension St. Vincent
Indianapolis, Indiana, United States
Ochsner Clinic
New Orleans, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
University of Maryland
Baltimore, Maryland, United States
Johns Hopkins
Baltimore, Maryland, United States
Suburban Hospital
Bethesda, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Baystate Health
Springfield, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Mid America Health Institute
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Northwell Health System
Great Neck, New York, United States
The Mount Sinai Hospital
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
WakeMed
Raleigh, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Ascension St. John
Tulsa, Oklahoma, United States
University of Pittsburgh Medical Center
Hermitage, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Michael E. DeBakey VA Medical Center
Houston, Texas, United States
Baylor Research Institute
Plano, Texas, United States
Intermountain CV Research
Murray, Utah, United States
University of Utah
Salt Lake City, Utah, United States
University of Vermont
Burlington, Vermont, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Inova Health
Falls Church, Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
University of Alberta Hospital
Edmonton, Alberta, Canada
London Health Sciences Centre
London, Ontario, Canada
Sunnybrook Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, Canada
University of Ottawa Heart Institute
Ottawa, , Canada
Hôpital Laval
Québec, , Canada
Toronto General Hospital
Toronto, , Canada
University Heart Center Hamburg
Berlin, Brandenburg, Germany
Heart Center Leipzig
Berlin, Brandenburg, Germany
University Medical Center Göttingen
Göttingen, Lower Saxony, Germany
University Medical Center Jena
Jena, Thuringia, Germany
Kerckhoff Klinik, Bad Nauheim
Bad Nauheim, , Germany
Clinic Bad Neustadt - Medical Center for Heart and Vascular Diseases
Bad Neustadt an der Saale, , Germany
HDZ-NRW Bad Oeynhausen
Bad Oeynhausen, , Germany
Charité Berlin - Benjamin Franklin Campus
Berlin, , Germany
Charité Berlin - Rudolf Virchow Campus
Berlin, , Germany
German Heart Center Berlin
Berlin, , Germany
University Hospital Bonn
Bonn, , Germany
Medical Center Braunschweig
Braunschweig, , Germany
Heinrich Heine University Düsseldorf
Düsseldorf, , Germany
Frankfurt University Hospital
Frankfurt, , Germany
University Medical Center Frankfurt
Frankfurt, , Germany
Heart Center, University of Freiburg
Freiburg im Breisgau, , Germany
University Medical Center Halle
Halle, , Germany
University Medical Center Heidelberg
Heidelberg, , Germany
University Medical Center Schleswig-Holstein Kiel
Kiel, , Germany
University Medical Center Schleswig-Holstein Lübeck
Lübeck, , Germany
University Hospital Magdeburg
Magdeburg, , Germany
German Heart Center Munich
Munich, , Germany
Medical Center of the Ludwig-Maximilians-University Munich
Munich, , Germany
University of Oldenburg
Oldenburg, , Germany
Hospital of the Brothers of Mercy Trier
Trier, , Germany
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, England, United Kingdom
Barts Health NHS Trust
London, England, United Kingdom
Imperial College Healthcare NHS Trust
London, England, United Kingdom
Royal Wolverhampton NHS Trust
Wolverhampton, England, United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, , United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, , United Kingdom
Royal Papworth Hospital NHS Foundation Trust
Cambridge, , United Kingdom
Hull University Teaching Hospitals NHS Trust
Cottingham, , United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
South Tees Hospitals NHS Foundation Trust
Middlesbrough, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
University Hospitals Sussex NHS Foundation Trust
Worthing, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Christiane Miesel-Groeschel
Role: primary
References
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Taha A, Nielsen SJ, Bergfeldt L, Ahlsson A, Friberg L, Bjorck S, Franzen S, Jeppsson A. New-Onset Atrial Fibrillation After Coronary Artery Bypass Grafting and Long-Term Outcome: A Population-Based Nationwide Study From the SWEDEHEART Registry. J Am Heart Assoc. 2021 Jan 5;10(1):e017966. doi: 10.1161/JAHA.120.017966. Epub 2020 Nov 30.
Related Links
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The Cardiothoracic Surgical Trials Network
Other Identifiers
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GCO 08-1078
Identifier Type: -
Identifier Source: org_study_id
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