Hermitage

Researchers are evaluating the effectiveness and safety of adding oral anticoagulation (OAC) to standard antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. This phase 3, multicenter, open-label, randomized trial aims to compare the prevention of thromboembolic events like stroke or heart attack against the risk of 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 groups: the OAC-based strategy group receiving oral anticoagulants such as vitamin K antagonists or direct oral anticoagulants combined with antiplatelet therapy, or the control group receiving antiplatelet therapy alone with aspirin or a P2Y12-inhibitor. The anticoagulation treatment is given for 90 days, with the possibility for patients in the control arm who develop recurrent atrial fibrillation after 30 days to switch to anticoagulation. The study follow-up includes visits at 90 days and phone calls at 30, 60, and 180 days. Up to 500 patients may participate in a digital health substudy using a wearable heart rhythm monitor for 30 days after discharge. During the study, researchers will monitor participants for serious events such as death, ischemic stroke, transient ischemic attack, myocardial infarction, and thromboembolism up to 180 days after randomization. Safety is assessed by tracking major bleeding events up to 90 days. Data from the registry group will be analyzed to compare risk profiles and treatment strategies. Participants will be evaluated through clinical visits, phone follow-ups, medical record reviews, and in some cases, digital monitoring to understand treatment effects and safety over time.