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

This study is looking at whether adding oral anticoagulants (blood thinners like apixaban, rivaroxaban, edoxaban, dabigatran, or warfarin) to standard antiplatelet therapy (aspirin or clopidogrel/ticagrelor) is better and safer for patients who develop new atrial fibrillation (an irregular heartbeat) after coronary artery bypass graft (CABG) surgery. Researchers want to see if this combination prevents serious problems like stroke, heart attack, or blood clots, while also checking for major bleeding. You might be able to join if you are 18 or older, had isolated CABG surgery, and developed new atrial fibrillation that lasted over 60 minutes or happened more than once within 7 days after your surgery. The study is currently recruiting 3200 participants, but the overall status is unclear.

Study design
This is an interventional study where participants are randomly assigned to receive either oral anticoagulants plus antiplatelet therapy, or antiplatelet therapy alone. It is an open-label study, meaning both you and your doctors will know which treatment you are receiving.
What's involved
You would receive either oral anticoagulants plus antiplatelet therapy or antiplatelet therapy alone for 90 days. The study will track your health for up to 180 days after you are assigned to a treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 180 days after they are assigned to a treatment to monitor for serious events and bleeding.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04045665

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Icahn School of Medicine at Mount Sinai
~3,200 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:Antiplatelet-only strategyOral Anticoagulant plus background antiplatelet therapy

At a glance

Recruiting sites
63 of 106 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite of death, ischemic stroke, TIA, MI, systemic arterial thromboembolism or venous thromboembolism (DVT and/or PE)
Measured over up to 180 days after randomization
+1 more outcome measured
Atrial Fibrillation
Stroke
Bleeding
106 sites across 39 states
Germany21
United Kingdom12
Massachusetts4
New York4
Brazil4
England4
California3
Indiana3
  • Annetine C Gelijns, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
  • Marc Gillinov, MD · STUDY_DIRECTOR · The Cleveland Clinic
  • John Alexander, MD · STUDY_DIRECTOR · Duke University

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Eligibility criteria

Inclusion

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

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)
Cardiogenic shock
Major perioperative complication\* occurring between CABG and randomization
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
  • 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 590 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)