NCT05702034

A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE

A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15,000 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.

Conditions

• Ischemic Stroke; Ischemic Attack, Transient

Interventions

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

Timeline

• Start date: 2023-02-15
• Primary completion: 2026-11-11
• Completion: 2026-12-09
• First posted: 2023-01-27
• Last updated: 2026-04-13

Locations

880 sites across 47 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Poland, Portugal, Romania, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study