Timing of anticoagulation after emergency endovascular therapy for acute ischaemic stroke with atrial fibrillation (TIMERS): protocol for a randomised controlled trial.

Abstract

The optimal timing for direct oral anticoagulants (DOACs) initiation after acute ischaemic stroke in patients with atrial fibrillation (AF) remains unclear, particularly in those undergoing endovascular thrombectomy (EVT), who are at higher risk of both haemorrhagic transformation and early embolic recurrence. Patients undergoing thrombectomy have been under-represented in previous randomised trials, resulting in limited evidence for guiding management in this high-risk population. The TIMERS trial aims to evaluate the efficacy and safety of early versus delayed initiation of DOACs therapy after EVT in patients with large vessel occlusion stroke and AF. This is a multicentre, prospective, randomised, open-label trial with a blinded outcome assessment. In total, 438 patients with acute ischaemic stroke and AF treated with EVT will be enrolled in this study. Patients will be randomised in a 1:1 ratio within 72 hours after stroke onset to early initiation (≤4 days) or delayed initiation (5-14 days). The primary outcome is a composite of recurrent ischaemic stroke, symptomatic intracranial haemorrhage or all-cause death within 90 days. Secondary outcomes include individual components of the primary endpoint, venous thromboembolism, systemic embolism, myocardial infarction, functional outcome (modified Rankin Scale), health-related quality of life (EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)) and major extracranial bleeding events. The study is approved by the Ethics Committee of Xuanwu Hospital of Capital Medical University, the ethics approval document number is (2025)259-001. The trial findings will be disseminated through peer-reviewed publications and presentations at scientific conferences. NCT07139301.