Phase 2
N=1,808
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.
Acute Non-cardioembolic Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT04304508 ↗Enrolled (actual)
1,808
Serious AEs
20.4%
Results posted
Apr 2023
Primary outcome: Primary: Efficacy-Number of Participants With Composite of Symptomatic Ischemic Stroke or Covert Brain Infarcts Detected by Magnetic Resonance Imaging (MRI) — 24; 25; 17; 23 Participants — p=0.7976
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BAY2433334 (Drug); BAY2433334 matching placebo (Other)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy-Number of Participants With Composite of Symptomatic Ischemic Stroke or Covert Brain Infarcts Detected by Magnetic Resonance Imaging (MRI) |
24; 25; 17; 23; 56; 57 | 0.7976 |
| PRIMARY Safety-Number of Participants With Composite of International Society on Thrombosis and Hemostasis (ISTH) Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding |
19; 14; 19; 52; 11 | = 0.1507 |
| SECONDARY Efficacy-Number of Participants With Composite of Symptomatic Ischemic Stroke and Covert Brain Infarcts Detected by MRI, Cardiovascular (CV) Death, Myocardial Infarction (MI) and Systemic Embolism. |
24; 25; 17; 23; 3; 2 | — |
| SECONDARY Efficacy-Number of Participants With Symptomatic Ischemic Stroke |
26; 26; 22; 28 | — |
| SECONDARY Efficacy-Number of Participants With Covert Brain Infarcts Detected by MRI |
62; 68; 63; 60 | — |
| SECONDARY Efficacy-Number of Participants With Symptomatic Ischemic Stroke, CV Death, MI |
33; 30; 33; 35 | — |
| SECONDARY Efficacy-Number of Participants With Symptomatic Ischemic and Hemorrhagic Stroke |
26; 26; 25; 30 | — |
| SECONDARY Efficacy-Number of Participants With Disabling Stroke (mRS≥4) |
5; 5; 1; 3 | — |
| SECONDARY Efficacy-Number of Participants With All-cause Mortality |
10; 6; 17; 10 | — |
| SECONDARY Safety-Number of Participants With All Bleeding |
37; 48; 48; 44 | — |
| SECONDARY Safety-Number of Participants With ISTH Major Bleeding |
4; 3; 7; 4 | — |
| SECONDARY Safety-Number of Participants With ISTH CRNM Bleeding |
15; 12; 12; 7 | — |
| SECONDARY Safety-Number of Participants With ISTH Minor Bleeding |
21; 39; 34; 34 | — |
| SECONDARY Safety-Number of Participants With Intracerebral Hemorrhage (Non-traumatic) |
0; 0; 3; 1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04304508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.