Asundexian Bleeding Analysis Finds Increased Lower Gastrointestinal Bleeding in OCEANIC-STROKE

A bleeding analysis of the randomized OCEANIC-STROKE trial evaluated asundexian versus placebo added to antiplatelet therapy in patients with noncardioembolic ischemic stroke or high-risk transient ischemic attack. The safety population comprised 12,254 participants who received at least one dose. Bleeding was classified using International Society on Thrombosis and Haemostasis criteria, with on-treatment analyses including events through two days after the last dose.

Major bleeding occurred in 117 of 6,124 asundexian recipients (1.9%) and 107 of 6,130 placebo recipients (1.7%; cause-specific hazard ratio [csHR], 1.10; 95% CI, 0.85–1.44). Major or clinically relevant nonmajor bleeding occurred in 5.5% versus 5.0% (csHR, 1.12; 95% CI, 0.96–1.30), and any bleeding in 12.5% versus 12.3%. Symptomatic intracranial hemorrhage occurred in 0.7% versus 0.6%.

Any gastrointestinal bleeding was more frequent with asundexian: 3.0% versus 2.4% (csHR, 1.28; 95% CI, 1.03–1.59). Lower gastrointestinal bleeding occurred in 1.7% versus 1.0% (csHR, 1.75; 95% CI, 1.27–2.41), primarily rectal bleeding. Major and major-or-clinically-relevant-nonmajor bleeding results were consistent across prespecified subgroups, including planned dual antiplatelet therapy.

These findings clarify the bleeding profile alongside the trial’s reported ischemic stroke reduction. Nonsignificant overall bleeding differences do not establish equivalence, and the gastrointestinal signal warrants attention. The supplied abstract does not quantify stroke reduction or provide follow-up duration, limiting assessment of absolute benefit–risk balance.