Status:
COMPLETED
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.
Lead Sponsor:
Bayer
Collaborating Sponsors:
Population Health Research Institute
Conditions:
Acute Non-cardioembolic Ischemic Stroke
Eligibility:
All Genders
45+ years
Phase:
PHASE2
Brief 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 follo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2022
Estimated Enrollment :
1808 Patients enrolled
Trial Details
Trial ID
NCT04304508
Start Date
June 15 2020
End Date
February 18 2022
Last Update
April 19 2023
Active Locations (197)
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1
Univ.of South Florida College of Medicine
Tampa, Florida, United States, 33606
2
Minneapolis Clinic of Neurology, Ltd.
Golden Valley, Minnesota, United States, 55422
3
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
4
Guilford Neurologic Associates
Greensboro, North Carolina, United States, 27405