Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG

NCT04045665 · tracked via the Priya Life Science Germany tracker

Sponsor

Icahn School of Medicine at Mount Sinai

Phase

Phase 3

Started

2019-12-13

Last updated

2026-06-26

Condition(s) studied

Atrial FibrillationStrokeBleeding

Investigational drug(s) / intervention(s)

Antiplatelet-only strategyOral Anticoagulant plus background antiplatelet therapy

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)

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Composite of death, ischemic stroke, TIA, MI, systemic arterial thromboembolism or venous thromboembolism (DVT and/or PE) — up to 180 days after randomization
Composite score of death, ischemic stroke, transient ischemic attack (TIA), myocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (deep venous thrombosis and/or pulmonary embolism). Composite score calculated by number of events.
Any BARC type 3 or 5 — 90 days after randomization
The Bleeding Academic Research Consortium (BARC) - any type 3 or 5 bleeding thrombosis and/or pulmonary. Type 3: a. Overt bleeding plus hemoglobin drop of 3 to \< 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding b. Overt bleeding plus hemoglobin drop \< 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents c. Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision. type 5: a. Probable fatal bleeding b. Definite fatal bleeding (overt or autopsy or imaging confirmation)

Trial sites (106)

Facility	City	Region	Status
CHI St. Vincent, Arkansas	Little Rock	Arkansas	Recruiting
University of Southern California	Los Angeles	California	Recruiting
Cedars-Sinai Medical Center	Los Angeles	California	Recruiting
Stanford University	Stanford	California	Recruiting
Medical Center of Aurora	Aurora	Colorado	Active Not Recruiting
Western Connecticut Hospital Systems	Danbury	Connecticut	Active Not Recruiting
Yale Medicine	New Haven	Connecticut	Recruiting
MedStar Washington Hospital Center	Washington D.C.	District of Columbia	Recruiting
Emory University	Atlanta	Georgia	Recruiting
Piedmont Healthcare Inc.	Atlanta	Georgia	Recruiting
Lutheran Medical Center	Fort Wayne	Indiana	Active Not Recruiting
Indiana University	Indianapolis	Indiana	Active Not Recruiting
Ascension St. Vincent	Indianapolis	Indiana	Active Not Recruiting
Ochsner Clinic	New Orleans	Louisiana	Recruiting
Maine Medical Center	Portland	Maine	Recruiting
University of Maryland	Baltimore	Maryland	Recruiting
Johns Hopkins	Baltimore	Maryland	Recruiting
Suburban Hospital	Bethesda	Maryland	Active Not Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
Brigham and Women's Hospital	Boston	Massachusetts	Recruiting
Boston Medical Center	Boston	Massachusetts	Active Not Recruiting
Baystate Health	Springfield	Massachusetts	Active Not Recruiting
University of Michigan	Ann Arbor	Michigan	Recruiting
Mayo Clinic	Rochester	Minnesota	Recruiting
Mid America Health Institute	Kansas City	Missouri	Recruiting
Washington University School of Medicine	St Louis	Missouri	Recruiting
Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	Recruiting
Jersey Shore University Medical Center	Neptune City	New Jersey	Recruiting
Northwell Health System	Great Neck	New York	Recruiting
The Mount Sinai Hospital	New York	New York	Withdrawn
Columbia University Medical Center	New York	New York	Recruiting
Montefiore Medical Center	The Bronx	New York	Recruiting
Duke University	Durham	North Carolina	Recruiting
East Carolina University	Greenville	North Carolina	Recruiting
WakeMed	Raleigh	North Carolina	Withdrawn
Cleveland Clinic Foundation	Cleveland	Ohio	Recruiting
Ohio State University Medical Center	Columbus	Ohio	Active Not Recruiting
Ascension St. John	Tulsa	Oklahoma	Active Not Recruiting
University of Pittsburgh Medical Center	Hermitage	Pennsylvania	Withdrawn
University of Pennsylvania	Philadelphia	Pennsylvania	Recruiting

+ 66 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04045665 on ClinicalTrials.gov ↗ ← All trials in Germany