OCEANIC-STROKE Trial Results Demonstrate Oral Factor XIa Inhibitor Reduces Risk of Recurrent Stroke

Treatment with the investigational oral factor XIa (FXIa) inhibitor asundexian (Bayer, Berlin, Germany) significantly reduced risk of recurrent ischemic stroke without increasing major bleeding in people with recent noncardioembolic ischemic stroke or high-risk transient ischemic attack (TIA), according to results from the phase 3 OCEANIC-STROKE trial (NCT05686070) presented at the International Stroke Conference (ISC) 2026. In the global study, once-daily oral treatment with asundexian 50 mg lowered ischemic stroke risk by 26% compared with placebo when added to antiplatelet therapy, with a safety profile comparable to placebo.

OCEANIC-STROKE was a multicenter, international, randomized, double-blind, placebo-controlled, event-driven phase 3 trial that enrolled 12,327 individuals worldwide. Eligible participants had experienced a noncardioembolic ischemic stroke or high-risk TIA and were treated with standard antiplatelet therapy. Participants were randomized to receive asundexian 50 mg once daily or placebo. The primary efficacy end point was time to ischemic stroke, and the primary safety end point was International Society on Thrombosis and Hemostasis (ISTH) major bleeding. Participants with a broad range of stroke subtypes were included, classified using Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria.

Key findings from OCEANIC-STROKE include the following:

• Asundexian treatment reduced the risk of recurrent ischemic stroke by 26% compared with placebo (cause-specific hazard ratio [csHR], 0.74; 95% CI, 0.65 to 0.84; P<.0001).
• The risk of stroke of any type (ischemic or hemorrhagic) was also reduced by 26% with asundexian (6.6% vs 8.8%; HR, 0.74; 95% CI, 0.65 to 0.84; P<.0001).
• There was no increase in ISTH major bleeding with asundexian compared with placebo (1.9% vs 1.7%; HR, 1.10; 95% CI, 0.85–1.44).
• Bleeding risks for minor bleeding, hemorrhagic stroke, symptomatic intracranial hemorrhage, and fatal bleeding were similar between treatment groups.
• Reductions in recurrent ischemic stroke were consistent across prespecified subgroups, including age, sex, stroke subtype, National Institutes of Health Stroke Scale (NIHSS) score, and use of single or dual antiplatelet therapy.

Asundexian has received FDA Fast Track designation for secondary stroke prevention but is not yet approved for clinical use.

Source: Bayer. Bayer’s asundexian demonstrated a substantial 26% reduction in stroke after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack, with no increase in ISTH major bleeding versus placebo. Businesswire. Published February 5, 2025. Accessed February 5, 2025. https://www.businesswire.com/news/home/20260205888712/en/Bayers-Asundexian-Demonstrated-a-Substantial-26-Reduction-in-Stroke-After-a-Non-Cardioembolic-Ischemic-Stroke-or-High-Risk-Transient-Ischemic-Attack-With-No-Increase-in-ISTH-Major-Bleeding-Versus-Placebo