The OCEANIC-STROKE trial, a large placebo-controlled phase 3 study, tested the factor XIa inhibitor asundexian (50 mg daily) in patients with acute non-cardioembolic ischemic stroke or high-risk TIA in combination with standard antiplatelet therapy.[1][2] More than 12,300 participants from around the world were included in the study.[2][4] Asundexian reduced the risk of recurrent ischemic stroke by 26% versus placebo without increasing the risk of major bleeding according to the ISTH.[1][2][3] The study met the primary efficacy and safety objectives.[1][4] Results were consistent regardless of age, gender, event type, stroke severity, or acute treatment.[2][5] This is the first successfully completed phase 3 study of a factor XIa inhibitor that demonstrated superiority over placebo in preventing recurrent stroke.[2][4] The results were presented at the 2026 International Stroke Conference in New Orleans.[2][3]