Trials / Active Not Recruiting
Active Not RecruitingNCT05757869
A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants With Atrial Fibrillation
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 20,284 (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 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
| Type | Name | Description |
|---|---|---|
| DRUG | Milvexian | Milvexian will be administered orally. |
| DRUG | Apixaban | Apixaban will be administered orally. |
| DRUG | Placebo | Milvexian matching milvexian placebo will be administered orally. |
| DRUG | Apixaban Placebo | Apixaban matching apixaban placebo will be administered orally. |
Timeline
- Start date
- 2023-04-11
- Primary completion
- 2026-10-31
- Completion
- 2026-10-31
- First posted
- 2023-03-07
- Last updated
- 2026-04-13
Locations
1,052 sites across 39 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05757869. Inclusion in this directory is not an endorsement.