Study to Gather Information About Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following a Recent Non Cardioembolic Ischemic Stroke Which Occurs When a Blood Clot Has Formed Somewhere in the Human Body (But Not in the Heart) Travelled to the Brain.

  • STATUS
    Recruiting
  • End date
    Feb 15, 2022
  • participants needed
    1800
  • sponsor
    Bayer
Updated on 12 July 2021

Summary

The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works on top of antiplatelet therapy in patients following a recent non cardioembolic ischemic stroke which occurs when a blood clot that has not formed in the heart travelled to the brain. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.

Details
Condition Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke
Treatment BAY2433334, BAY2433334 matching placebo
Clinical Study IdentifierNCT04304508
SponsorBayer
Last Modified on12 July 2021

Eligibility

Yes No Not Sure

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

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
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