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Evaluating anticoagulation for new atrial fibrillation after heart surgery

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

PHASE3 · Icahn School of Medicine at Mount Sinai · NCT04045665

This study is testing if adding a blood thinner to regular heart medication can help patients who develop new atrial fibrillation after heart surgery, while also keeping an eye on any bleeding risks.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment3200 (estimated)
Ages18 Years and up
SexAll
SponsorIcahn School of Medicine at Mount Sinai (other)
Locations101 sites (Little Rock, Arkansas and 100 other locations)
Trial IDNCT04045665 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have undergone isolated CABG and developed persistent or recurrent POAF.

Not a fit: Patients with a history of atrial fibrillation or those requiring long-term anticoagulation prior to surgery will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the risk of thromboembolic events in patients with new-onset POAF after CABG surgery.

How similar studies have performed: Previous studies have shown promise in using anticoagulation strategies for atrial fibrillation, but this specific approach in the post-operative setting is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Little Rock, Arkansas and 100 other locations

+51 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Atrial Fibrillation, Stroke, Bleeding, Anticoagulation, Antiplatelet Therapy, Post Operative Atrial Fibrillation

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.