Document Type
Article
Publication Date
8-29-2024
Abstract
BACKGROUND: Direct oral anticoagulants are the standard of care for stroke prevention in eligible patients with atrial fibrillation and atrial flutter; however, bleeding remains a significant concern, limiting their use. Milvexian is an oral Factor XIa inhibitor that may offer similar anticoagulant efficacy with less bleeding risk.
METHODS: LIBREXIA AF (NCT05757869) is a global phase III, randomized, double-blind, parallel-group, event-driven trial to compare milvexian with apixaban in participants with atrial fibrillation or atrial flutter. Participants are randomly assigned to milvexian 100 mg or apixaban (5 mg or 2.5 mg per label indication) twice daily. The primary efficacy objective is to evaluate if milvexian is noninferior to apixaban for the prevention of stroke and systemic embolism. The principal safety objective is to evaluate if milvexian is superior to apixaban in reducing the endpoint of International Society of Thrombosis and Hemostasis (ISTH) major bleeding events and the composite endpoint of ISTH major and clinically relevant nonmajor (CRNM) bleeding events. In total, 15,500 participants from approximately 1,000 sites in over 30 countries are planned to be enrolled. They will be followed until both 430 primary efficacy outcome events and 530 principal safety events are observed, which is estimated to take approximately 4 years.
CONCLUSION: The LIBREXIA AF study will determine the efficacy and safety of the oral Factor XIa inhibitor milvexian compared with apixaban in participants with either atrial fibrillation or atrial flutter.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05757869.
Recommended Citation
Jain, Sneha S; Mahaffey, Kenneth W; Pieper, Karen S; Shimizu, Wataru; Potpara, Tatjana; Ruff, Christian T; Kamel, Hooman; Lewis, Basil S; Cornel, Jan H; Kowey, Peter R.; Horrow, Jay; Strony, John; Plotnikov, Alexei N; Li, Danshi; Weng, Stephen; Donahue, Julia; Gibson, C Michael; Steg, P Gabriel; Mehran, Roxana; Weitz, Jeffrey I; Johnston, S Claiborne; Hankey, Graeme J; Harrington, Robert A; and Lam, Carolyn S P, "Milvexian vs Apixaban for Stroke Prevention in Atrial Fibrillation: The LIBREXIA Atrial Fibrillation Trial Rationale and Design" (2024). Department of Medicine Faculty Papers. Paper 462.
https://jdc.jefferson.edu/medfp/462
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.
PubMed ID
39214801
Language
English
Comments
This article is the author's final published version in American Heart Journal, Volume 277, November 2024, Pages 145-158.
The published version is available at https://doi.org/10.1016/j.ahj.2024.08.011
Copyright © 2024 The Author(s).