A study to learn more about asundexian for prevention of stroke in male and female participants who already had such a stroke due to a blood clot that formed outside the heart and travelled to the brain, or temporary stroke-like symptoms.
Phase 3
- Conditions
- Health Condition 1: I699- Sequelae of unspecified cerebrovascular diseases
- Registration Number
- CTRI/2024/01/061517
- Lead Sponsor
- Bayer Pharmaceuticals Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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 less than or equal to 7 days before the index stroke event
2. Index stroke following procedures or strokes due to other rare causes
3. History of atrial fibrillation or 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 Efficacy - <br/ ><br> <br/ ><br>To evaluate whether the oral FXIa inhibitor asundexian is superior to placebo on top of background antiplatelet therapy in reducing ischemic stroke in patients after an acute non-cardioembolic ischemic stroke or high-risk Transient ischemic attack(TIA) <br/ ><br> <br/ ><br>Safety - <br/ ><br> <br/ ><br>To compare the incidence of International Society on Thrombosis and Hemostasis (ISTH) major bleeding for asundexian and placebo on top of antiplatelet therapy in patients after an acute non cardioembolic ischemic stroke or high-risk TIATimepoint: Up to 31 months
- Secondary Outcome Measures
Name Time Method Efficacy - <br/ ><br> <br/ ><br>To evaluate whether asundexian is superior to placebo on top of antiplatelet therapy in reducing the occurrence of composite and individual efficacy endpoints <br/ ><br> <br/ ><br>Safety - <br/ ><br> <br/ ><br>To compare asundexian and placebo on top of antiplatelet therapy with respect to individual bleeding endpoints <br/ ><br> <br/ ><br>Net clinical benefit: <br/ ><br> <br/ ><br>To further compare the benefit and risk of asundexian and placebo with respect to a composite of efficacy and safety endpointsTimepoint: Up to 31 months