A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation
NCT05757869 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20284
Last updated 2026-05-08
Summary
The purpose of this study is to evaluate if milvexian is at least as effective as apixaban for reducing the risk of the composite stroke and non-central nervous system (CNS) systemic embolism.
Conditions
Interventions
- DRUG
-
Milvexian
Milvexian will be administered orally.
- DRUG
-
Apixaban
Apixaban will be administered orally.
- DRUG
-
Milvexian matching milvexian placebo will be administered orally.
- DRUG
-
Apixaban Placebo
Apixaban matching apixaban placebo will be administered orally.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Janssen Research & Development, LLC
lead INDUSTRY
Principal Investigators
-
Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-11
- Primary Completion
- 2026-10-31
- Completion
- 2026-10-31
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Belgium
- Brazil
- Bulgaria
- Canada
- Chile
- China
- Croatia
- Czechia
- Denmark
- Estonia
- France
- Germany
- Greece
- Hungary
- India
- Israel
- Italy
- Japan
- Latvia
- Lithuania
- Malaysia
- Netherlands
- New Zealand
- Philippines
- Poland
- Portugal
- Romania
- Serbia
- Singapore
- Slovakia
- South Africa
- South Korea
- Spain
- Taiwan
- Turkey (Türkiye)
- United Kingdom
Study Locations
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