Oral factor xia inhibitor milvexian after a recent acute coronary syndrome: Rationale and design of the phase 3 (Librexia ACS)
Why the study?
Patients remain at risk for recurrent ischemic events after ACS despite antiplatelet therapy, and factor XIa inhibition may reduce thrombin generation and improve outcomes with minimal bleeding risk.
Does milvexian reduce the composite of cardiovascular death, myocardial infarction, or ischemic stroke in patients with a recent acute coronary syndrome?
Population
Approximately 16,000 patients with a recent ACS and at least 2 risk-enhancing factors
Comparison
Oral milvexian (25 mg twice daily) vs matched placebo, added to conventional antiplatelet therapy
Design
Phase 3, randomized, double-blind, placebo-controlled, event-driven trial
Follow-up
Until 875 events are accrued
Authors
Discussion
Loading...
Member takes
Implication
Milvexian added to antiplatelet therapy after ACS is unlikely to reduce MACE; challenges factor XIa inhibition for secondary prevention in this setting.
Structured PICO
Does milvexian reduce the composite of cardiovascular death, myocardial infarction, or ischemic stroke in patients with a recent acute coronary syndrome?
P
Population
Approximately 16,000 patients with a recent acute coronary syndrome (symptoms of spontaneous ischemia, diagnosis of ACS and cardiac biomarker elevation indicative of myonecrosis within 7 days before randomization, along with at least 2 risk-enhancing factors).
I
Intervention
Oral milvexian (25 mg twice daily) in addition to conventional antiplatelet therapy
C
Comparator
Matched placebo in addition to conventional antiplatelet therapy
O
Outcome
Time to first occurrence of the composite of cardiovascular death, myocardial infarction (MI), or ischemic strokecomposite
The Librexia-ACS trial will evaluate whether the oral factor XIa inhibitor milvexian, added to standard antiplatelet therapy, reduces ischemic events without significantly increasing bleeding in patients with recent acute coronary syndromes.
Cite This Study
Gibson et al. (2025) studied this question.