A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation

• Status: Not yet recruiting
• Trial end date: 2027-05-05
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate if milvexian is atleast as effective as apixaban for reducing the risk of the composite stroke and non- central nervous system (CNS) systemic embolism.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Collaborator: Bristol-Myers Squibb
• Treatments: Apixaban

Criteria

Inclusion Criteria:

• Minimum age of 18 years

• Medically stable and appropriate for chronic antithrombotic treatment

• Atrial fibrillation eligible to receive anticoagulation

• Participant must satisfy one or both of the following categories of risk factors (a or b): a) one or more of the following risk factors: i) age less than or equal to 75 years, ii) history of a clinical symptomatic stroke. b) two or more of the following risk factors: i) age between 65 and 74 years, ii) hypertension, iii) diabetes mellitus, iv) atherosclerotic vascular disease, v) heart failure

Exclusion Criteria:

• Hemodynamically significant valve disease that will potentially require surgical valve replacement during the study

• Any condition other than AF that requires chronic anticoagulation