Overview
- Final LIBREXIA ACS results presented at ESC Congress on Saturday, Aug. 29, 2026 show the primary outcome of cardiovascular death, myocardial infarction, or ischemic stroke occurred in 5.4% of patients on milvexian versus 5.1% on placebo (HR 1.05; 95% CI 0.91–1.21; P = 0.50).
- The trial was stopped for futility after a prespecified interim analysis in November 2025 when the independent data monitoring committee judged the study unlikely to meet its primary efficacy endpoint.
- There was no difference in the principal safety outcome of intracranial, vision‑threatening intraocular, or fatal bleeding (BARC 3c/5), with both groups showing equally low rates of those events.
- Pharmacodynamic testing showed expected anticoagulation with milvexian (trough aPTT increased about 1.6‑fold), and investigators cited possible reasons for the null result including an insufficient dose, most benefit being limited to early months after ACS, and widespread use of potent dual antiplatelet therapy and high revascularization rates in the trial population.
- The LIBREXIA program continues with higher‑dose and different‑indication trials — notably LIBREXIA AF (milvexian 100 mg twice daily versus apixaban) and LIBREXIA Stroke — which will test whether alternate doses, timing, or patient groups can show benefit.