ABSTRACT NUMBER: ESOC2026OT190 COMBINATION ANTITHROMBOTIC TREATMENT FOR PREVENTION OF RECURRENT ISCHEMIC STROKE IN INTRACRANIAL ATHEROSCLEROTIC DISEASE. CATIS-ICAS

Abstract Background and aims ICAD is a common cause of stroke with high recurrence risk even with current guidelines recommended treatment. COMPASS trial (N~27,000) that had patients with systemic atherosclerotic disease showed benefit of low-dose rivaroxaban+ASA in preventing recurrent ischemic stroke without increasing ICH. A pilot study (CATIS-ICAD, N=101) with this combination in those with stroke or high risk TIA attributable to ICAD 30-99% showed feasibility, safety and trend towards efficacy for preventing recurrent ischemic and covert stroke without increasing ICH. Methods CATIS-ICAS aims to demonstrate superiority of rivaroxaban 2.5mg BID+ ASA to DAPT for 90days followed by ASA to prevent strokes in those with ischemic stroke secondary to ICAD of 30-99% Results Global, double-blind, randomized, placebo- controlled phase III study with adaptive design. 1172 patients will be randomized to either the experimental arm or the control arm with in 30 days of the event. Patients >40, with ischemic stroke or high risk TIA, attributable to ICAD 30-99% of a major intracranial artery by MRA/CTA/DSA and mRs < 4 will be eligible. Conclusions Primary outcome: All recurrent strokes (ischemic, hemorrhagic and undefined) Secondary safety outcomes: Hemorrhagic stroke, ISTH major hemorrhage, ISTH clinically relevant non-major bleeding Secondary efficacy outcomes: Ischemic or undefined stroke, MACE, disabling or fatal stroke Conflict of interest