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# Bayer Stops Stroke Drug Study Over Inferiority
- URL: https://www.fdaweb.com/bayer-stops-stroke-drug-study-over-inferiority/
- Published: 2023-11-20T12:00:00.000Z
- Updated: 2026-09-14T14:16:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155828

Bayer says it is stopping its Phase 3 OCEANIC-AF study evaluating asundexian compared to apixaban (Bristol-Myers Squibb’s Eliquis) in patients with atrial fibrillation at risk for stroke due to an “inferior efficacy” comparison. The decision is based on the recommendation of the study’s independent data monitoring committee.

“Although the results from this analysis do not support the continuation of the OCEANIC-AF study, we will continue investigating asundexian in the OCEANIC-STROKE study and are currently reevaluating other indications in patients in need of antithrombotic treatment,” the company says. [**OCEANIC-STROKE**](https://www.clinicaltrials.gov/study/NCT05686070?ref=fdaweb.com) is a Phase 3 study investigating asundexian for preventing ischemic strokes compared to placebo on top of standard-of-care antiplatelet therapy in patients after an acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack (mini-stroke).

Asundexian is described as an oral direct, potent inhibitor of activated coagulation factor XI that “acts selectively on the coagulation cascade, thereby offering the potential to prevent events like stroke without a corresponding increase in bleeding risk associated with the current standard of care.”