NCT05754957

A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14,194 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate that milvexian is superior to placebo, in addition to standard-of-care, in reducing the risk of major adverse cardiovascular event (MACE) (the composite of cardiovascular \[CV\] death, myocardial infarction \[MI\], and ischemic stroke).

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Milvexian	Milvexian will be administered orally.
OTHER	Placebo	Placebo will be administered orally.

Timeline

• Start date: 2023-04-07
• Primary completion: 2026-02-06
• Completion: 2026-02-06
• First posted: 2023-03-06
• Last updated: 2026-04-13

Locations

1,003 sites across 44 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, North Macedonia, Philippines, Poland, Portugal, Romania, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study