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.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
With
Population Health Research Institute
Age
45–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | 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.
