A Study of Milvexian Versus Apixaban in Participants with Atrial Fibrillatio

Phase 3

Recruiting

• Conditions: Atrial Fibrillation

• Registration Number: JPRN-jRCT2051230052
• Lead Sponsor: umaguchi Hirotaka

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15500

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 greater 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 or those with valve disease that will potentially require surgical valve replacement during the study
- Any condition other than AF that requires chronic anticoagulation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to the First Occurrence of Composite Endpoint of Stroke and Non-central nervous system (CNS) Systemic Embolism : Up to 4 years : Time to the first occurrence of composite endpoint of stroke and non-CNS systemic embolism will be reported.