Actively Recruiting
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-01-20
3200
Participants Needed
101
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research evaluates the use of oral anticoagulation OAC combined with background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation POAF after isolated coronary artery bypass graft CABG surgery. The study aims to assess how effectively this approach prevents thromboembolic events and its safety regarding major bleeding. Patients who decline randomization may join a parallel registry to capture their treatment choices and risk profiles. Participants will be randomly assigned to one of two treatment groups an experimental arm receiving OAC either a vitamin K antagonist or a direct oral anticoagulant along with antiplatelet therapy, or a control arm receiving antiplatelet therapy alone. The anticoagulation treatment lasts 90 days, and patients in the control group who experience recurrent atrial fibrillation after 30 days may switch to OAC. Follow-up includes clinic visits at 90 days and phone calls at 30, 60, and 180 days. A digital health substudy involving a wearable heart monitor for 30 days post-discharge is also offered to some participants. During the study, researchers will monitor outcomes such as death, stroke, transient ischemic attack, myocardial infarction, and thromboembolism up to 180 days after randomization, along with bleeding events at 90 days. Data collection includes medical record reviews, risk profiling, and use of anticoagulants and antiplatelets. Safety and effectiveness will be analyzed by comparing the two treatment strategies. Participation may last up to six months, with assessments conducted in person and by phone.
CONDITIONS
Brief Title
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older who undergo isolated CABG surgery for coronary artery disease
- New-onset postoperative atrial fibrillation lasting more than 60 minutes or recurrent episodes within 7 days after CABG surgery
You will not qualify if you...
- History of permanent, persistent, or paroxysmal atrial fibrillation
- Existing need for long-term oral anticoagulation
- Any absolute contraindication to oral anticoagulation
- Planned use of dual antiplatelet therapy after surgery
- Cardiogenic shock
- Major complications between CABG and randomization, including stroke, TIA, myocardial infarction, major bleeding, severe infection, kidney failure requiring dialysis, or bleeding requiring reoperation
- Concomitant left atrial appendage closure during CABG
- Concomitant valve surgery or prior valve surgery
- Mitral valve annuloplasty during CABG
- Carotid artery endarterectomy during CABG
- Aortic root replacement during CABG
- Surgery for atrial fibrillation during CABG
- Liver cirrhosis or severe chronic liver disease (Child-Pugh Class C)
- Use of investigational drugs or devices within 30 days before randomization or plan to enroll in another investigational trial
- Pregnancy at the time of randomization
- Unable or unwilling to provide informed consent or comply with study procedures
- Underlying disease limiting life expectancy to less than one year
Research Team
E
Ellen Moquete, RN
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