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The study has not yet received FDA approval for stroke prevention; Bayer funded the trial and supplied the drug and placebo.

Findings were presented at the American Stroke Association’s International Stroke Conference 2026.

Asundexian, an investigational Factor XI inhibitor added to standard antiplatelet therapy in the large OCEANIC-STROKE trial, reduced recurrent ischemic stroke without boosting bleeding risk.

Oceanic-Stroke enrolled over 12,300 patients and met primary efficacy and safety endpoints, signaling potential global impact given the ~12 million strokes worldwide annually.

No evidence of increased intracranial or major bleeding and an overall net benefit for patients was observed.

Current guidelines generally favor antithrombotic therapy for stroke survivors to prevent recurrence; long-term dual antiplatelet therapy is reserved for specific high-risk cases.

Results are preliminary and presented at a conference; confirmation will require peer-reviewed publication.

The trial enrolled more than 12,300 adults across 702 sites in 37 countries, with follow-up ranging from several months up to just over two and a half years.

The drug’s mechanism targets Factor XI to prevent large clot formation while maintaining a lower bleeding risk than Factor Xa–targeting therapies.

Compared with placebo, asundexian plus antiplatelet therapy cut ischemic stroke by about one-quarter and lowered rates of disabling stroke, major bleeding, and serious adverse events, with reductions in cardiovascular death and other outcomes.

Limitations include relatively few participants with severe strokes, and a imaging substudy is ongoing to further evaluate clotting and bleeding effects.