The CATIS-ICAS phase III trial will evaluate the superiority of rivaroxaban 2.5mg BID plus ASA compared to DAPT for preventing recurrent strokes in 1172 patients with intracranial atherosclerosis.
RCT (n=1,172)
Double-blind
Randomized
Yes
Does rivaroxaban 2.5mg BID + ASA reduce all recurrent strokes in patients >40 with ischemic stroke or high risk TIA attributable to ICAD 30-99% compared to DAPT followed by ASA?
The CATIS-ICAS trial aims to determine if low-dose rivaroxaban plus aspirin is superior to DAPT followed by aspirin for preventing recurrent strokes in patients with intracranial atherosclerotic disease.
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
Perera et al. (Fri,) conducted a rct in Ischemic stroke or high risk TIA secondary to intracranial atherosclerotic disease (ICAD) (n=1,172). Rivaroxaban plus aspirin (ASA) vs. Dual antiplatelet therapy (DAPT) for 90 days followed by ASA was evaluated on All recurrent strokes (ischemic, hemorrhagic and undefined). The CATIS-ICAS phase III trial will evaluate the superiority of rivaroxaban 2.5mg BID plus ASA compared to DAPT for preventing recurrent strokes in 1172 patients with intracranial atherosclerosis.