Oral Factor XIa Inhibitor Asundexian Reduced Recurrent Stroke Risk in Study Published in NEJM

Treatment with asundexian (Bayer, Berlin, Germany) was associated with reduced recurrent ischemic stroke without an increase in 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) published in The New England Journal of Medicine. Asundexian is an investigational oral factor XIa inhibitor designed to reduce pathologic thrombosis while preserving hemostasis.

OCEANIC-STROKE was a double-blind, event-driven, placebo-controlled trial conducted at 702 centers in 37 countries. A total of 12,327 adult participants were randomized within 72 hours of symptom onset to receive asundexian 50 mg once daily (n=6162) or placebo (n=6165), in addition to planned single or dual antiplatelet therapy. Eligible participants had noncardioembolic ischemic stroke or high-risk TIA and at least 1 qualifying feature: nonlacunar infarct on imaging, history of atherosclerosis, or cerebrovascular imaging evidence of atherosclerotic plaque. The primary efficacy outcome was ischemic stroke, and the primary safety outcome was International Society on Thrombosis and Haemostasis (ISTH) major bleeding.

Key Findings

• Ischemic stroke occurred in 6.2% of participants receiving asundexian vs 8.4% receiving placebo (cause-specific hazard ratio [csHR], 0.74; 95% CI, 0.65 to 0.84; P<.001).
• Stroke of any type occurred in 6.6% vs 8.8% (csHR, 0.74; 95% CI, 0.65 to 0.84; P<.001).
• The composite of cardiovascular death, myocardial infarction, or stroke occurred in 9.2% vs 11.1% (csHR, 0.83; 95% CI, 0.74 to 0.92; P<.001).
• Ischemic stroke within the first 90 days was not significantly lower with asundexian (3.0% vs 3.5%; csHR, 0.84; 95% CI, 0.69 to 1.02; P=.08), stopping formal hierarchical testing of lower secondary endpoints.
• ISTH major bleeding occurred in 1.9% of participants treated with asundexian and 1.7% with placebo (csHR, 1.10; 95% CI, 0.85 to 1.44; P=.46).
• Major or clinically relevant nonmajor bleeding, symptomatic intracranial hemorrhage, hemorrhagic stroke, fatal bleeding, and minor bleeding were also similar between groups.

Adverse event rates were comparable between groups (69.3% with asundexian vs 70.1% with placebo), as were serious adverse events (19.2% vs 19.5%).

Source

Sharma M, Dong Q, Hirano T, et al. Asundexian for Secondary Stroke Prevention. N Engl J Med. 2026;394(15):1467-1479. doi:10.1056/NEJMoa2513880