Arrhythmias & electrophysiology
Milvexian vs apixaban for stroke prevention in atrial fibrillation: The LIBREXIA atrial fibrillation trial rationale and design
Study context
- Population
- Participants with AF or atrial flutterplanned
- Participants
- 15,500 participants
- Planned comparison
- Milvexian vs apixaban
- Primary endpoint
- Stroke and systemic embolism (noninferiority of milvexian vs apixaban)
Methodological detailsrationale and design, phase III, double-blind, parallel-group, event-driven, global, noninferiority (efficacy), ≈1,000 sites in over 30 countries, Follow-up until 430 primary efficacy events and 530 principal safety events (≈4 years), Principal safety objective: superiority for International Society of Thrombosis and Hemostasis (ISTH) major bleeding and composite of ISTH major and clinically relevant nonmajor (CRNM) bleeding
- Rationale and design
- Phase III
- Double-blind
- Parallel-group
- Event-driven
- Global
- Noninferiority (efficacy)
- ≈1,000 sites in over 30 countries
- Follow-up until 430 primary efficacy events and 530 principal safety events (≈4 years)
- Principal safety objective: superiority for ISTH major bleeding and composite of ISTH major and CRNM bleeding
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Milvexian vs apixaban for stroke prevention in atrial fibrillation: The LIBREXIA atrial fibrillation trial rationale and design. Am Heart J. Published 29 August 2024. doi:10.
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