One of cardiology’s most closely watched bets has cleared its last enrollment-and-follow-up hurdle. The status of LIBREXIA-ACS (NCT05754957), Johnson & Johnson’s Phase 3 trial of the investigational oral Factor XIa inhibitor milvexian, has been updated to “Completed” on ClinicalTrials.gov, with a completion date of February 6, 2026.
The trial is large by any standard: 14,194 participants randomized across 1,003 sites since it began in April 2023. Run by Janssen Research & Development with Bristol-Myers Squibb as collaborator, it enrolled adults aged 18 and older after a recent acute coronary syndrome and tested milvexian against placebo, both added to standard of care.
What the readout will test
The primary endpoint is the time to a first major adverse cardiovascular event (MACE), a composite of cardiovascular death, myocardial infarction, and ischemic stroke, assessed over up to three years and six months. Secondary endpoints include a broader vascular composite — adding major adverse limb events and symptomatic venous thromboembolism — along with all-cause mortality and cardiovascular death.
The wager behind Factor XIa inhibition is that you can blunt clotting without paying the bleeding penalty that has long constrained anticoagulation.
That hypothesis is what milvexian must now prove at scale. The “Completed” flag confirms the trial reached its event-driven endpoint; on its own, it does not indicate whether milvexian succeeded. No results have been posted to the registry, and no efficacy or safety figures are available from this primary source.
Until the data table or a peer-reviewed paper appears, the only certainty is timing: a major cardiology readout is now queued. This is journalism, not medical or investment advice.