Comparing Aspirin Alone Versus Aspirin Plus Clopidogrel After Left Atrial Appendage Closure in Atrial Fibrillation Patients Phase 4 Randomized Clinical Trial

What this Trial Is About

The APPENDAGE study is a phase 4 multicenter randomized clinical trial evaluating two antithrombotic strategies after left atrial appendage closure LAAC in patients with non-valvular atrial fibrillation AF. It aims to compare aspirin alone versus aspirin combined with clopidogrel to assess their effectiveness in preventing ischemic brain lesions, which are detected by cerebrovascular MRI scans. This research addresses the challenge of balancing bleeding risk and thromboembolic risk after LAAC, a procedure recommended for stroke prevention in AF patients who cannot use oral anticoagulation. Participants receive either aspirin plus clopidogrel or aspirin alone starting on the day of the LAAC procedure and continuing for three months. The LAAC is performed using devices such as the Watchman or Amplatzer Cardiac PlugAmulet. Brain MRI scans are performed immediately after the procedure and again at three months to detect ischemic lesions. The study also includes neurological tests like the NIH Stroke Scale, Modified Rankin Score, and Montreal Cognitive Assessment to evaluate functional and cognitive impacts. During the study, participants are monitored for neurological events, bleeding complications, device-related thrombus, and treatment adherence. Assessments occur at baseline, day 1, and month 3, including MRI, neurological tests, and evaluation of systemic and cerebral events. The primary outcome is the change in ischemic lesions on brain MRI over three months. Participant involvement includes follow-up visits for clinical and cognitive assessments, with a total study duration of three months after the LAAC procedure.

AntiPlatelet theraPy stratEgy followiNg Left Atrial appenDAGe closurE