Major perioperative complication* occurring between CABG and randomizationĪ. This includes, but is not limited to, patients with recent PCI with drug-eluting or bare-metal stent. Planned use of post-operative dual antiplatelet therapy (DAPT)Ī. Any pre-existing clinical indication for long-term OAC.Clinical history of either permanent, persistent or paroxysmal atrial fibrillation.POAF that persists for >60 minutes or is recurrent (more than one episode) within 7 days after the index CABG surgery.Patients of age ≥18 years who undergo isolated CABG for coronary artery disease.The incidence of BARC 2 bleeding at 90 days after randomization.Number of non-cardiovascular mortalities.Number of participants with venous thromboembolism event.Number of participants with systematic arterial thromboembolism event.Number of participants with TIA event. Number of participants with Stroke event.the confidence intervals will be compared to this curve. NCB will be assessed as a two-dimensional outcome with the observed NCB plotted versus effectiveness and safety, and a curve drawn. The trial will be conducted by the Cardiothoracic Surgical Trials Network (CTSN), the German Society for Thoracic and Cardiovascular Surgery (DGTHG) and other European sites, the United Kingdom and Brazil.Īnticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABGĭefined as the integration of the trial's primary effectiveness and safety endpoint to capture overall risk and benefit of anticoagulation. This is a multicenter randomized clinical trial comparing OAC to no-OAC in addition to concomitant antiplatelet therapy in 3,200 eligible patients who develop POAF after isolated CABG. Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Up to 500 patients will also be offered the option to participate in a digital health substudy which includes a wearable heart rhythm monitor device for 30 days post discharge. Patients will be offered the option of having biospecimens collected for future research. The usage of anticoagulant and antiplatelet therapies in the registry population overall and baseline CHA2DS2-VASC stroke risk score will also be determined. The baseline risk profile of registry patients (i.e., patients eligible but unwilling to be randomized) will be analyzed and compared to that of patients randomized in the trial. Study follow-up visits will be performed at 90 days and phone follow-up at 180 days.ĭata for patients enrolled in the registry will be ascertained from the local clinical site via a review of medical records. Patients, who are randomized to the control arm and develop recurrent AF after 30 days, may be crossed-over to an OAC. The protocol-specified duration of anticoagulation is 90 days.
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