|Principal Investigator: Craig Selzman|
|Keywords: Atrial Fibrillation , Stroke , Bleeding , Anticoagulant||Department: Cardiothoracic Division|
|IRB Number: 00127064|
|Specialty: Cardiothoracic Surgery|
|Recruitment Status: Recruiting|
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.
The primary aim of this trial is to compare the effectiveness and safety of using OACs versus no OACs in isolated CABG patients who develop POAF. The primary effectiveness endpoint is the composite of death, stroke, transient ischemic attack (TIA), myocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (VTE) at 90 days after randomization. The primary safety endpoint is BARC (Bleeding Academic Research Consortium) grade 3 or 5 bleeding at 90 days after randomization. The overall intent is to evaluate the trade-off in prevention of thromboembolic events versus an increase in bleeding.
The secondary aim of this trial is to evaluate the burden of atrial fibrillation over one year post randomization using continuous monitoring devices in patients who have developed new-onset POAF after CABG. This aim will be addressed in an ancillary study.