Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after CABG (PACeS)
Brief description of study
The overall 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 post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery.
Detailed description of study
Patients will be randomly assigned to the following treatment strategies:
- OAC-based strategy (experimental arm): OAC with vitamin K antagonist (VKA) with international normalized ratio (INR) target 2-3 or any approved direct oral anticoagulant (apixaban, rivaroxaban, edoxaban or dabigatran) in addition to background antiplatelet therapy with aspirin 75-325mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)
- Antiplatelet-only strategy (control arm): single antiplatelet therapy with aspirin 75-325mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)
The protocol-specified duration of anticoagulation is 90 days. Patients, who are randomized to the control arm and develop recurrent AF after 30 days, may be crossed-over to an OAC. Accrual is expected to take 60 months. Study follow-up visits will be performed at 90 days and phone follow-up at days 30, 60, and 180 days.
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: Between 18 Years - 99 Years
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Gender: All
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
- Planned use of post-operative dual antiplatelet therapy (DAPT)
- Cardiogenic shock