Phase 3 study with FXIa inhibitor stopped early due to inferior efficacy


News - Nov. 21, 2023

The OCEANIC-AF study will be stopped early due to a lack of efficacy. The study investigates the effects of FXIa inhibitor asundexian compared to apixaban on the risk of stroke and systemic embolism in patients with AF at risk of stroke.

This decision follows the recommendation of the Independent Data Monitoring Committee. Interim results showed an inferior efficacy of asundexian versus apixaban. The safety profile of asundaxian remains consistent with previously reported safety data.

Asundexian will be continued to be investigated in the OCEANIC-STROKE study.

Source: Press release Bayer, November 19, 2023

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