心房颤动
药效学
心脏病学
医学
内科学
心力衰竭
药代动力学
作者
Julie Vassart,Marie Didembourg,Laure Morimont,Clotilde Brisbois,Laurent Jamart,Aurélien Lebreton,François Mullier,Nathalie Donis,Julien Favresse,Jean‐Michel Dogné,Jonathan Douxfils
标识
DOI:10.1016/j.thromres.2024.03.001
摘要
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] Bayer OCEANIC-AF study stopped early due to lack of efficacy. https://www.bayer.com/media/en-us/oceanic-af-study-stopped-early-due-to-lack-of-efficacy/Date: 2023 Date accessed: November 19, 2023 Google Scholar ]. 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.
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