Vassart J. et al. (2024) Asundexian in atrial fibrillation: Can pharmacodynamic data explain the failure? Thrombosis Research 236 (2024) 236–239.
The phase 3 OCEANIC-AF trial (NCT05643573) of the investigational oral activated factor XI (FXIa) inhibitor asundexian (Bayer, Leverkusen, Germany) tested at the dose of 50 mg has been stopped early due to an inferior efficacy of asundexian versus the control arm (apixaban) for the prevention of strokes and systemic embolisms in patients with atrial fibrillation (AF). This decision is based on the recommendation of the study’s independent data monitoring committee (IDMC) as part of ongoing surveillance [1]. No additional details were available when this manuscript was written. The Phase 3 trial LIBREXIA-AF (NCT05757869), a randomized, double-blind study that evaluates the efficacy and safety of milvexian versus apixaban in AF is ongoing. Results are expected in 2027.
