A study to learn how well the study treatment asundexian works and how safe it is compared to apixaban to prevent strokeor systemic embolism in people with irregular and often rapid heartbeat (atrial fibrillation), and at risk for stroke
Phase 3
- Conditions
- Health Condition 1: I482- Chronic atrial fibrillation
- Registration Number
- CTRI/2023/10/058195
- Lead Sponsor
- Bayer Pharmaceuticals Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 9
Inclusion Criteria
1. 18 years of age or older (at legal age of consent according to local legislation) at the time of signing the informed consent.
2. Atrial fibrillation documented by ECG evidence with an indication for indefinite treatment with an oral anticoagulant.
3. CHA2DS2-VASc score = 3 if male or = 4 if female,
OR
CHA2DS2-VASc score of 2 if male or 3 if female and
enrichment criteria.
Exclusion Criteria
1. Mechanical heart valve prosthesis
2. Moderate-to-severe mitral stenosis at the time of inclusion into the study
3. Atrial fibrillation only due to reversible cause
4. Requirement for chronic anticoagulation for a different indication than atrial fibrillation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to first occurrence of composite of stroke or systemic embolism <br/ ><br> <br/ ><br>Timepoint: Up to 34 months
- Secondary Outcome Measures
Name Time Method