A multicenter, international, randomized, placebo controlled, double-blind, parallel group and event driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA
Phase 3
Recruiting
- Conditions
- ischemic strokestroke10014523
- Registration Number
- NL-OMON51380
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 105
Inclusion Criteria
1. Participants must be >= 18 years of age
2. Acute non-cardioembolic stroke or high-risk TIA
3. Systemic or cerebrovascular atherosclerosis or acute non-lacunar infarct
Exclusion Criteria
1. Ischemic stroke <= 7 days before the index stroke event
2. Index stroke following procedures or strokes due to other rare causes
3. History of atrial fibrillation/flutter, left ventricular thrombus, mechanic
valve or other cardioembolic source of stroke requiring anticoagulation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- ischemic stroke.<br /><br>- ISTH major bleeding.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- All strokes (ischemic and hemorrhagic)<br /><br>- Composite of CV death, MI or stroke<br /><br>- Composite of all-cause mortality, MI or stroke<br /><br>- Disabling stroke (mRS >=3 at 90 days)<br /><br>- All-cause mortality<br /><br>- Transient ischemic attack (TIA)<br /><br>- Composite of ISTH major or clinically relevant non-major bleeding<br /><br>- ISTH clinically relevant non-major bleeding<br /><br>- Symptomatic intracranial hemorrhage<br /><br>- Hemorrhagic stroke<br /><br>- Fatal bleeding<br /><br>- Minor bleeding<br /><br>- Composite of ischemic stroke or ISTH major bleeding<br /><br>- Composite of CV death, all stroke, MI or ISTH major bleeding<br /><br>- Composite of all-cause mortality, disabling stroke, fatal bleeding,<br /><br>symptomatic intracranial hemorrhage</p><br>