Comparing Apixaban, Left Atrial Appendage Closure, and Standard Care for Stroke Prevention in Adults with Atrial Fibrillation and a History of Intracerebral Hemorrhage

What this Trial Is About

This research aims to determine the best way to prevent stroke and systemic embolism in adults with non-valvular atrial fibrillation AF who have previously experienced an intracerebral haemorrhage ICH. Oral anticoagulant drugs have shown benefits in preventing stroke in AF patients, but these drugs were not tested in patients with prior ICH. This trial addresses the uncertainty about whether patients with AF and past ICH should use oral anticoagulants, undergo left atrial appendage closure LAAC, or avoid anticoagulation. Participants are randomly assigned to one of three groups treatment with the oral anticoagulant Apixaban 5 mg twice daily, treatment with LAAC devices chosen by local teams, or usual care with avoidance of anticoagulation and LAAC, which may include antiplatelet drugs or no antithrombotic treatment. The trial follows patients for 24 months to compare the net clinical benefit, including both major ischaemic and haemorrhagic events. During the study, participants undergo assessments including brain imaging, clinical evaluations using the Modified Rankin Scale and EQ-5D quality of life measures, and monitoring for adverse events. The primary outcome is a composite of major cardiovascular or cerebrovascular ischaemic or haemorrhagic events over 24 months. Secondary outcomes include individual event components, death, and complications related to endovascular treatment. The study is designed to help guide clinical decisions on the safest and most effective stroke prevention strategy for this patient group.

Avoiding Anticoagulation After IntraCerebral Haemorrhage