Oral factor xia inhibitor milvexian after a recent acute coronary syndrome: Rationale and design of the phase 3 (Librexia acute coronary syndromes (ACS))
Study context
- Population
- Patients after a recent ACS with symptoms of spontaneous ischemia, a diagnosis of ACS and cardiac biomarker elevation indicative of myonecrosis within 7 days before randomization, along with at least 2 risk-enhancing factors, on conventional antiplatelet therapyplanned enrollment, follow-up until 875 events are accrued
- Participants
- ≈16,000 patients
- Planned comparison
- Oral milvexian vs matched placebo in addition to conventional antiplatelet therapy after a recent ACS
- Primary endpoint
- Time to first occurrence of the composite of:
- Cardiovascular death
- Myocardial infarction (MI)
- Ischemic stroke
Methodological detailsrationale and design, randomization stratified according to the planned duration and type of antiplatelet therapy
- Rationale and design
- Randomization stratified according to the planned duration and type of antiplatelet therapy
No results yet. This paper sets out the design of a trial; its results are to come.
Further findings
First major secondary endpoint: time to the first occurrence of cardiovascular death, myocardial infarction (MI), ischemic stroke, major adverse limb events, and symptomatic venous thromboembolism
- Design only; no result reported
Original publication
Oral factor xia inhibitor milvexian after a recent acute coronary syndrome: Rationale and design of the phase 3 (Librexia ACS). Am Heart J. Published 20 February 2025. doi:10.
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