A Phase 3, Randomized, Double-blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, After a Recent Acute Coronary Syndrome

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group, event-driven, superiority, group sequential study to evaluate the efficacy and safety of milvexian in participants enrolled within 7 days of an ACS. Participants will receive either milvexian (25 mg twice daily orally) or a matching placebo on a background of standard-of-care antiplatelet therapy. This study will include 3 phases: a screening phase up to 7 days after the index ACS event and prior to randomization, a double-blind treatment phase, and a 30-day follow-up phase. Treatment will begin on the day of randomization and continue until the target number of participants with one or more primary efficacy outcome events has been achieved (followed by an EOT visit [within 30 days after GTED]). Thus, treatment duration with study intervention will be variable depending on when the participant is randomized. It is anticipated that the last participant randomized will have a minimum of approximately 3 months of treatment with study intervention by the time of the GTED. The study conduct will be overseen by the Executive Committee and Steering Committee.