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.
Condition: Acute Non-cardioembolic Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Intervention: BAY2433334; BAY2433334 matching placebo
Intervention description: Tablet, taken orally once a day.; Tablet, taken orally once a day.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1808.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No

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.
    

Eligibility 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

        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.