Evaluating anticoagulation for new atrial fibrillation after heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the effectiveness and safety of adding oral anticoagulation (OAC) to standard antiplatelet therapy in patients who experience new-onset post-operative atrial fibrillation (POAF) following coronary artery bypass graft (CABG) surgery. It is a multicenter, open-label, randomized trial that compares outcomes between patients receiving OAC and those on antiplatelet therapy alone. The primary focus is on preventing thromboembolic events while monitoring for major bleeding complications over a 90-day period. Patients who decline randomization will be enrolled in a parallel registry to capture their treatment strategies and outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• CHI St. Vincent, Arkansas
  Little Rock, Arkansas, United States Recruiting
• University of Southern California
  Los Angeles, California, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Stanford University
  Stanford, California, United States Recruiting
• Yale Medicine
  New Haven, Connecticut, United States Recruiting
• MedStar Washington Hospital Center
  Washington D.C., District of Columbia, United States Recruiting

+56 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Annetine C Gelijns, PhD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Jonathan Hupf
• Email: Jonathan.Hupf@mountsinai.org
• Phone: (212) 659-6862

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.