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.
Completed · Phase 2 · Has a placebo group
Conditions studied: Acute Non-cardioembolic Ischemic Stroke
In brief
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.
Key facts
- Study ID
- NCT04304508
- Run by
- Bayer
- People needed
- 1808
- Starts
- 2020-06-15
- Expected to finish
- 2022-02-18
- Last updated by the study team
- 2023-04-19
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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.
Where it is running
- Minneapolis Clinic of Neurology, Ltd. — Golden Valley, Minnesota, United States
- St. Luke's Hospital of Kansas City — Kansas City, Missouri, United States
- Guilford Neurologic Associates — Greensboro, North Carolina, United States
- University of Pittsburgh Medical Center Hamot — Erie, Pennsylvania, United States
- Liverpool Hospital — Liverpool, New South Wales, Australia
- John Hunter Hospital — New Lambton, New South Wales, Australia
- Royal North Shore Hospital — Sydney, New South Wales, Australia
- Sunshine Coast University Hospital — Birtinya, Queensland, Australia
- Gold Coast University Hospital — Southport, Queensland, Australia
- Royal Adelaide Hospital — Adelaide, South Australia, Australia
- Grampians Health Ballarat — Ballarat, Victoria, Australia
- Eastern Clinical Research Unit - Box Hill — Box Hill, Victoria, Australia
- Royal Melbourne Hospital — Parkville, Victoria, Australia
- The Alfred Hospital — Prahran, Victoria, Australia
- Fiona Stanley Hospital — Murdoch, Western Australia, Australia
- Krankenhaus der Barmherzigen Brüder Eisenstadt — Eisenstadt, Burgenland, Austria
- Medizinische Universität Innsbruck — Innsbruck, Tyrol, Austria
- Konventhospital Barmherzige Brüder Linz — Linz, Upper Austria, Austria
- Christian-Doppler-Klinik — Salzburg, Austria
- Krankenhaus der Barmherzigen Brüder — Vienna, Austria
- Universitätsklinikum AKH Wien — Vienna, Austria
- Klinik Favoriten - Sozialmedizinisches Zentrum Süd — Vienna, Austria
- Jessa Ziekenhuis — Hasselt, Limburg, Belgium
- CHC MontLégia — Liège, Liège, Belgium
- Univ.of South Florida College of Medicine — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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