An acute non-cardioembolic ischemic stroke
Conditions
Sponsors
Bayer Yakuhin, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: -Participant must be 45 years of age and older at the time of signing the informed consent -Non-cardioembolic ischemic stroke with persistent signs and symptoms of stroke lasting for >= 24 hours OR acute brain infarction documented by computed tomography (CT) or MRI AND with the intention to be treated with antiplatelet therapy during the study conduct -Imaging of brain (CT or MRI) ruling out hemorrhagic stroke or another pathology that could explain symptoms (e.g. brain tumor, abscess, vascular malformation) -Severity of index event nearest the time of randomization: Part A: minor stroke (defined as National Institutes of Health Stroke Scale (NIHSS) =< 7) can be enrolled 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 -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) -Ability to conduct an MRI either before randomization or within 72 hours after randomization
Exclusion criteria
Exclusion criteria: Exclusion Criteria: -Prior ischemic stroke within last 30 days of index event -History of atrial fibrillation or suspicion of cardioembolic source of stroke -Dysphagia with inability to safely swallow study medication -Contraindication to perform brain MRI -Part A only: thrombolysis or endovascular therapy (mechanical thrombectomy) performed for index event -Active bleeding; known bleeding disorder, history of major bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months of randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy -Number of participants with symptomatic ischemic stroke or covert brain infarcts detected by Magnetic resonance imaging (MRI) [ Time Frame: From baseline up to 6 months ] -Time from randomization to first occurrence of International Society on Thrombosis and Hemostasis (ISTH) major bleeding and clinically relevant non-major (CRNM) bleeding [ Time Frame: From baseline up to 12 months ] | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy -Number of participants with composite of symptomatic ischemic stroke and covert brain infarcts detected by MRI, Cardiovascular (CV) death, myocardial infarction and systemic embolism [ Time Frame: From baseline up to 12 months ] -Number of participants with covert brain infarcts detected by MRI [ Time Frame: From baseline up to 12 months ] -Time from randomization to first occurrence of symptomatic ischemic stroke [ Time Frame: From baseline up to 12 months ] -Time from randomization to first occurrence of symptomatic ischemic stroke, CV death, myocardial infarction [ Time Frame: From baseline up to 12 months ] -Time from randomization to first occurrence of symptomatic ischemic and hemorrhagic stroke [ Time Frame: From baseline up to 12 months ] -Time from randomization to first occurrence of disabling stroke [ Time Frame: From baseline up to 12 monthsModified ranking score (mRS) >=4 -Time from randomization to all-cause mortality [ Time Frame: From baseline up to 12 months ] -Time from randomization to first occurrence of all bleeding [ Time Frame: From baseline up to 12 months ] -Time from randomization to first occurrence of ISTH major bleeding [ Time Frame: From baseline up to 12 months ] -Time from randomization to first occurrence of ISTH CRNM bleeding [ Time Frame: From baseline up to 12 months ] -Time from randomization to first occurrence of ISTH minor bleeding [ Time Frame: From baseline up to 12 months ] -Time from randomization to first occurrence of Intracerebral hemorrhage (non-traumatic) [ Time Frame: From baseline up to 12 months ] | — |
Countries
Europe, Japan
Contacts
Public Contactcontact Dedicated
Bayer Yakuhin, Ltd.
Outcome results
None listed