JRCT ID: jRCT2080225214
Registered date:01/06/2020
Multicenter, Randomized,Placebo-controlled, Double-blind, Parallel Group, Dose-finding Phase 2 Study to Evaluate Efficacy and Safety of BAY2433334 in Patients Following an Acute Non-cardioembolic Ischemic Stroke
Basic Information
Recruitment status | completed |
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Health condition(s) or Problem(s) studied | An acute non-cardioembolic ischemic stroke |
Date of first enrollment | 16/03/2020 |
Target sample size | 1800 |
Countries of recruitment | Japan,Europe |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : BAY 2433334 INN of investigational material : - Therapeutic category code : 333 Anticoagulants Dosage and Administration for Investigational material : Tablet, taken orally once a day. control material(s) Generic name etc : placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : Tablet, taken orally once a day. |
Outcome(s)
Primary Outcome | 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 ] |
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Secondary Outcome | 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 ] |
Key inclusion & exclusion criteria
Age minimum | >= 45age old |
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Age maximum | Not applicable |
Gender | Both |
Include 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 |
Exclude 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 |
Related Information
Primary Sponsor | Bayer Yakuhin, Ltd. |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT04304508,JapicCTI-205310 |
Contact
Public contact | |
Name | contact Dedicated |
Address | 2-4-9 Umeda, Kita-ku, Osaka, Osaka |
Telephone | +81-6-6133-6363 |
byl_ct_contact@bayer.com | |
Affiliation | Bayer Yakuhin, Ltd. |
Scientific contact | |
Name | Masafumi Myoishi |
Address | 2-4-9 Umeda, Kita-ku, Osaka, Osaka |
Telephone | +81-6-6133-6363 |
byl_ct_contact@bayer.com | |
Affiliation | Bayer Yakuhin, Ltd. |