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. (PACIFIC-STROKE)

Bayer

Status and phase: Completed; Phase 2

Conditions: Acute Non-cardioembolic Ischemic Stroke

Treatments: Other: BAY2433334 matching placebo; Drug: BAY2433334

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04304508

2019-003431-33 (EudraCT Number)

19766

Details and patient eligibility

About

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.

Enrollment: 1,808 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,808 participants in 4 patient groups, including a placebo group

BAY2433334 high dose

Experimental group

Treatment:

Drug: BAY2433334

BAY2433334 medium dose

Experimental group

Treatment:

Drug: BAY2433334

BAY2433334 low dose

Experimental group

Treatment:

Drug: BAY2433334

BAY2433334 matching placebo

Placebo Comparator group

Treatment:

Other: BAY2433334 matching placebo