Multicenter, randomized, placebo-controlled, double-blind, parallel group, dose-finding Phase 2 study to evaluate efficacy and safety of BAY 2433334 in patients following an acute non-cardioembolic ischemic stroke
- Conditions
- ischemic strokestroke10014523
- Registration Number
- NL-OMON55288
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
1. Participant must be 45 years of age and older at the time of signing the
informed consent
2. Non-cardioembolic ischemic stroke with
a. persistent signs and symptoms of stroke lasting for * 24 hours OR
b. acute brain infarction documented by computed tomography (CT) or MRI AND
c. with the intention to be treated with antiplatelet therapy during the
study conduct
3. Imaging of brain (CT or MRI) ruling out hemorrhagic stroke or another
pathology that could explain symptoms (e.g. brain tumor, abscess, vascular
malformation)
4. Severity of index event nearest the time of randomization:
a. Part A: minor stroke (defined as NIHSS * 7) can be enrolled
b. Part B: participants with minor or moderate stroke and NIHSS * 15 can
be enrolled. Participants undergoing thrombolysis or endovascular therapy
(mechanical thrombectomy) can be enrolled but at the earliest 24 hours after
the intervention
5. Randomization within 48 hours after the onset of symptoms of the index event
(or after patients were last known to be without symptoms in case of wake-up
stroke)
6. Ability to conduct an MRI either before randomization or within 72 hours
after randomization
1. Prior ischemic stroke within last 30 days of index event
2. History of atrial fibrillation or suspicion of cardioembolic source of stroke
3. Dysphagia with inability to safely swallow study medication at time of
randomization
4. Contraindication to perform brain MRI
5. Part A only: thrombolysis or endovascular therapy (mechanical thrombectomy)
performed for index event
7. Active bleeding; known bleeding disorder, history of major bleeding
(intracranial, retroperitoneal, intraocular) or clinically significant
gastrointestinal bleeding within last 6 months of randomization
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Composite of symptomatic ischemic stroke and covert brain infarcts detected by<br /><br>MRI.<br /><br>Composite of International Society on Thrombosis and Hemostasis (ISTH) major<br /><br>bleeding and clinically relevant non-major (CRNM) bleeding</p><br>
- Secondary Outcome Measures
Name Time Method <p>Composite of symptomatic ischemic stroke and covert brain infarcts detected by<br /><br>MRI, CV death, myocardial infarction and systemic embolism<br /><br>Incidence of covert brain infarcts detected by MRI<br /><br>Hazard ratio of symptomatic ischemic stroke<br /><br>Hazard ratio of symptomatic ischemic stroke, CV death, myocardial infarction<br /><br>Hazard ratio of symptomatic ischemic and hemorrhagic stroke<br /><br>Hazard ratio of disabling stroke<br /><br>Hazard ratio of all-cause mortality<br /><br>Hazard ratio of all bleeding<br /><br>Hazard ratio of ISTH major bleeding<br /><br>Hazard ratio of ISTH CRNM bleeding<br /><br>Hazard ratio of ISTH minor bleeding<br /><br>Hazard ratio of Intracerebral hemorrhage (nontraumatic)</p><br>