Milvexian fails to reduce recurrent cardiovascular events in ACS trial
An international phase III trial of the factor XIa inhibitor milvexian, LIBREXIA ACS, was stopped for futility after an interim analysis found no benefit on the primary composite outcome of cardiovascular death, myocardial infarction, or ischemic stroke (384 events, 5.4% with milvexian; 365 events, 5.1% with placebo; hazard ratio 1.05, 95% CI 0.91–1.21; P=0.50) after a median 12.2 months. The study enrolled 14,194 patients and compared milvexian 25 mg twice daily added to antiplatelet therapy versus placebo. Importantly, major bleeding (BARC type 3c or 5) was similar at 0.3% in both groups, and the DSMB allowed two other phase III milvexian trials to continue with topline data expected in 2026.
Milvexian did not lower recurrent major cardiovascular events in LIBREXIA ACS.
Context
An interim review found the ACS trial unlikely to meet its main goal. The DSMB recommended stopping that trial for futility. Other phase III milvexian trials continue and have expected topline data in 2026.
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