Phase 3 trial of milvexian for ACS prevention completes enrollment

The LIBERATE trial is a Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of milvexian in participants after a recent acute coronary syndrome (ACS). The study's primary objective is to determine if milvexian, in addition to standard-of-care, is superior to placebo in reducing the risk of a major adverse cardiovascular event (MACE). The primary outcome measure is the time to the first occurrence of MACE, which is a composite of cardiovascular death, myocardial infarction, and ischemic stroke. The study enrolled 14,194 participants and has a follow-up duration of 34.0 months. The study sponsor is Janssen Research & Development, LLC. The study start date was April 7, 2023, and the primary completion date is February 6, 2026. The study status is listed as COMPLETED, which in this context refers to the completion of the enrollment and follow-up phases as per the provided timeline. The abstract does not report any efficacy results, safety data, or statistical outcomes such as hazard ratios, p-values, or confidence intervals. Therefore, no conclusions regarding the superiority or non-inferiority of milvexian compared to placebo can be drawn from the provided abstract information. The summary is limited to the design, population, and planned outcomes as explicitly stated in the abstract.