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

Recruiting now · Phase 3

Conditions studied: Atrial Fibrillation, Stroke, Bleeding

In brief

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.

Key facts

Study ID

NCT04045665

Run by

Icahn School of Medicine at Mount Sinai

People needed

3200

Starts

2019-12-13

Expected to finish

2026-08-31

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Northwell Health System — Great Neck, New York, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Jersey Shore University Medical Center — Neptune City, New Jersey, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• Yale Medicine — New Haven, Connecticut, United States (enrolling)
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
• Stanford University — Stanford, California, United States (enrolling)
• CHI St. Vincent, Arkansas — Little Rock, Arkansas, United States (enrolling)
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• Ochsner Clinic — New Orleans, Louisiana, United States (enrolling)
• Maine Medical Center — Portland, Maine, United States (enrolling)
• University of Maryland — Baltimore, Maryland, United States (enrolling)
• Johns Hopkins — Baltimore, Maryland, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Piedmont Healthcare Inc. — Atlanta, Georgia, United States (enrolling)
• University of Southern California — Los Angeles, California, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Mid America Health Institute — Kansas City, Missouri, United States (enrolling)
• East Carolina University — Greenville, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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