Overview and Design of the OCEANIC-STROKE Trial

Continuing the NeurologyLive® Special Report, Mike Sharma, MD, outlines the rationale and structure of the phase 3 OCEANIC-STROKE trial evaluating asundexian for secondary prevention following non-cardioembolic ischemic stroke or TIA. He details the trial’s eligibility criteria—including patients with NIHSS scores up to 15 or high-risk TIA (ABCD₂ ≥ 6)—and the decision to include adults without an upper age limit to reflect real-world stroke populations.

Dr. Sharma emphasizes the unmet therapeutic need among patients without cardioembolic sources, for whom aspirin remains the primary long-term therapy. He also describes how the inclusion of patients with documented atherosclerosis or embolic-appearing infarcts was informed by prior data and aimed to identify those most likely to benefit from factor XIa inhibition. With more than 12,000 patients randomized in just two years, OCEANIC-STROKE showcases the growing global capacity for collaborative stroke research and the urgency to find safer, more effective alternatives to existing antithrombotic regimens.