Bayer has announced the publication of full results from the Phase III OCEANIC-STROKE study in The New England Journal of Medicine. The study evaluates asundexian, an investigational Factor XIa (FXIa) inhibitor, for its efficacy in secondary stroke prevention.
Key Clinical Findings: The data demonstrate that asundexian (50 mg once daily), administered alongside standard antiplatelet therapy, provides significant benefits compared to placebo:
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Preventive Efficacy: A 26% reduction in the risk of ischemic stroke.
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Safety Profile: No observed increase in major bleeding risk as defined by the International Society on Thrombosis and Hemostasis (ISTH).
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Consistency: Positive outcomes were consistent across various patient subgroups, regardless of age, sex, or concurrent treatments such as single (SAPT) or dual antiplatelet therapy (DAPT).
Clinical Significance: Globally, approximately 12 million people experience a stroke annually, with 20–30% facing recurrent episodes. Recurrent strokes are often associated with higher rates of disability and mortality. Developing an agent that prevents pathological clot formation without compromising the body’s natural hemostasis is considered a major medical breakthrough. Bayer emphasized that the evidence from OCEANIC-STROKE will significantly contribute to the evolution of future secondary stroke prevention strategies.