OCEANIC-STROKE

Factor XIa Inhibition with Asundexian in Acute Non-Cardioembolic Stroke or High-Risk TIA

Patient / Population Intervention / Exposure Comparison Outcome

In 12,327 patients with non-cardioembolic stroke or high-risk TIA, asundexian reduced recurrent ischemic stroke compared with placebo.

12,327

Design

Phase 3, randomized, double-blind, placebo-controlled, event-driven trial; asundexian 50 mg once daily vs placebo added to single or dual antiplatelet therapy, started within 72 h of index event; 702 sites in 37 countries.

Endpoint

Primary efficacy: time to first ischemic stroke. Primary safety: ISTH major bleeding.

Relevance

ResultIschemic stroke 384/6162 (6.2%) vs 518/6165 (8.4%); cause-specific HR 0.74 (95% CI 0.65–0.84), p<0.001; 26% RRR; ARR 2.2%, source-stated NNT 53 (ARR 1.9% at 1 year). ISTH major bleeding 117 (1.9%) vs 107 (1.7%); HR 1.10 (0.85–1.44), p=0.46.

Sharma M, et al. Asundexian for Secondary Stroke Prevention. N Engl J Med. 2026;394:1467-1479. 10.1056/nejmoa2513880