Asundexian and Study Design of OCEANIC-STROKE Trial for Secondary Stroke Prevention

In “Asundexian and Study Design of OCEANIC-STROKE Trial for Secondary Stroke Prevention,” our panel delves into the following critical questions:

1. Please discuss study design for OCEANIC-STROKE.
   1. Study locations, patient numbers
   2. Patient demographics (stroke type, risk profile, age, etc.)
   3. Prior treatments
   4. Primary and secondary outcomes
2. Can you comment on patient demographics and how representative they may be of the patient population you see in your practice?

The OCEANIC Stroke trial enrolled 12,327 patients with non‑cardioembolic ischemic stroke or high‑risk TIA (ABCD2 ≥6; NIHSS up to 15) across 37 countries, randomized 1:1 to asundexian 50 mg versus placebo on top of planned antiplatelet therapy, and followed them for up to 31 months. The cohort was typical in age and stroke subtype (about 95% ischemic stroke; large‑artery atherosclerosis, cryptogenic, and enriched small‑vessel disease), with substantial use of reperfusion therapies (IV thrombolysis and thrombectomy in ~20–30%), but only one‑third were women and Black patients were underrepresented globally, in part due to lack of Sub‑Saharan African sites. Within the U.S., however, Black enrollment was roughly proportional to the underlying stroke population. Panelists felt the sample was broadly representative in terms of stroke mechanisms and severity (median NIHSS 2–3, with ~30% NIHSS ≥5), while noting important demographic limitations—especially for women and certain racial groups—driven by eligibility cri

Our next episode, “Results of OCEANIC-STROKE Trial for Secondary Stroke Prevention,” further explores results with asundexian in secondary stroke prevention.