A Study of Milvexian compared to Apixaban in subjects with Atrial Fibrillatio
- Conditions
- Health Condition 1: I48- Atrial fibrillation and flutter
- Registration Number
- CTRI/2024/01/061445
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Minimum age of 18 years
2.Medically stable and appropriate for chronic antithrombotic treatment
3.Atrial fibrillation eligible to receive anticoagulation
4.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
1.Hemodynamically significant valve disease or those with valve disease that will potentially require surgical valve replacement during the study
2.Any condition other than AF that requires chronic anticoagulation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate if milvexian is non-inferior to apixaban for the composite of stroke & non-CNS systemic embolismTimepoint: Time to the first occurrence of composite endpoint of stroke and non-CNS systemic <br/ ><br>Embolism. Time Frame: Up to 4 years
- Secondary Outcome Measures
Name Time Method To evaluate if milvexian is superior to apixaban in reducing risk of the principal safety endpoint family: <br/ ><br>- ISTH major bleeding <br/ ><br>-Composite of ISTH major & CRNM bleeding <br/ ><br>Timepoint: 4 years