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

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501176-26-00

Acronym

70033093STR3001

Enrollment

6471

Registered

2023-06-29

Start date

2023-08-04

Completion date

Unknown

Last updated

2025-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke and High-Risk Transient Ischemic Attack

Brief summary

Time to first occurrence of ischemic stroke

Detailed description

Time to first occurrence of any component of the composite of CVD, MI, or ischemic stroke, Time to first occurrence of ischemic stroke in the first 90 days, Time to first occurrence of any component of MAVE (ie, composite of CVD, MI, ischemic stroke, MALE, symptomatic PE or DVT)

Interventions

DRUGJNJ-70033093

DRUGCLOPIDOGREL

DRUGACETYLSALICYLIC ACID

DRUGMilvexian matching placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to first occurrence of ischemic stroke	—

Secondary

Measure	Time frame
Time to first occurrence of any component of the composite of CVD, MI, or ischemic stroke, Time to first occurrence of ischemic stroke in the first 90 days, Time to first occurrence of any component of MAVE (ie, composite of CVD, MI, ischemic stroke, MALE, symptomatic PE or DVT)	—

Countries

Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026