OCEANIC-STROKE Analysis: No Increase in Major Bleeding but More Lower GI Bleeding with Asundexian

Adding asundexian to antiplatelet therapy did not significantly increase major bleeding compared with placebo in patients with noncardioembolic ischemic stroke or high-risk transient ischemic attack (TIA), according to an analysis of the randomized OCEANIC-STROKE trial published in Circulation. Lower gastrointestinal (GI) bleeding, however, was more frequent with asundexian.

The investigators noted that OCEANIC-STROKE previously showed asundexian added to antiplatelet therapy reduced ischemic stroke without significantly increasing bleeding. The current analysis characterized bleeding by category, site, and key subgroups. The trial was sponsored by Bayer AG.

The safety population included 12,254 participants who received at least 1 dose of asundexian (n=6124) or placebo (n=6130). Bleeding was classified using International Society on Thrombosis and Haemostasis criteria, and while-on-treatment analyses included events through 2 days after the last dose. Major bleeding occurred in 1.9% of the asundexian group and 1.7% of the placebo group (cause-specific hazard ratio [csHR], 1.10; 95% CI, 0.85-1.44). Rates of major or clinically relevant nonmajor (CRNM) bleeding (5.5% vs 5.0%) and any bleeding (12.5% vs 12.3%) also did not differ significantly.

Any GI bleeding occurred in 3.0% of participants receiving asundexian vs 2.4% receiving placebo (csHR, 1.28; 95% CI, 1.03-1.59), and lower GI bleeding occurred in 1.7% vs 1.0% (csHR, 1.75; 95% CI, 1.27-2.41), primarily rectal bleeding. Symptomatic intracranial hemorrhage occurred in 0.7% and 0.6% of participants, respectively. Procedure-related and mucosal bleeding did not differ significantly between groups.

According to the investigators, treatment effects on major and major or CRNM bleeding were consistent across prespecified subgroups, including patients with planned dual antiplatelet therapy. The authors concluded that asundexian reduced ischemic stroke without significantly increasing major, major or CRNM, or any bleeding, while lower GI bleeding was more frequent. The sponsor was involved in the design, conduct, and reporting of the study.

Source: Eikelboom JW, Xu L, Shoamanesh A, et al. Bleeding with asundexian versus placebo in patients with noncardioembolic ischemic stroke or high-risk TIA: OCEANIC-STROKE randomized trial. Circulation. Published online October 13, 2026. doi:10.1161/CIRCULATIONAHA.126.081836