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.

Multicenter, randomized, placebo-controlled, double-blind, parallel group, dose-finding Phase 2 study to evaluate efficacy and safety of BAY 2433334 in patients following an acute non-cardioembolic ischemic stroke - PACIFIC-STROKE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003431-33-PT

Enrollment

1900

Registered

2020-01-02

Start date

2020-03-09

Completion date

Unknown

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-cardioembolic ischemic stroke MedDRA version: 22.1 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 100000004852 MedDRA version: 21.1 Level: LLT Classification code 10067625 Term: Secondary prevention System Organ Class: 100000004865

Interventions

Product Name: BAY 2433334 Product Code: BAY 2433334 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: NA CAS Number: 2064121-65-7 Current Sponsor code: BAY 2433334 TABL 5 MG 201 COAT Other

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participant must be 45 years of age and older at the time of signing the informed consent 2. Non-cardioembolic ischemic stroke with a. persistent signs and symptoms of stroke lasting for = 24 hours OR b. acute brain infarction documented by computed tomography (CT) or MRI AND c. with the intention to be treated with antiplatelet therapy during the study conduct 3. Imaging of brain (CT or MRI) ruling out hemorrhagic stroke or another pathology that could explain symptoms (e.g. brain tumor, abscess, vascular malformation) 4. Severity of index event nearest the time of randomization: a. Part A: minor stroke (defined as NIHSS = 7) can be enrolled b. 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 5. 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) 6. Ability to conduct an MRI either before randomization or within 72 hours after randomization Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 900 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 900

Exclusion criteria

Exclusion criteria: 1. Prior ischemic stroke within last 30 days of index event 2. History of atrial fibrillation or suspicion of cardioembolic source of stroke 3. Dysphagia with inability to safely swallow study medication at time of randomization 4. Contraindication to perform brain MRI 5. Part A only: thrombolysis or endovascular therapy (mechanical thrombectomy) performed for index event 6. Active bleeding; known bleeding disorder, history of major bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months of randomization

Design outcomes

Primary

Measure	Time frame
Main Objective: • To assess the dose response of 3 different doses of BAY 2433334 compared to placebo in reducing the composite of symptomatic ischemic strokes and covert brain infarcts detected by MRI as well as other cerebro- and cardiovascular endpoints in participants with an acute non-cardioembolic ischemic stroke and who are treated with antiplatelet therapy. • To evaluate whether the incidence of bleeding is similar for BAY 2433334 compared to placebo in participants with an acute non-cardioembolic ischemic stroke and who are treated with antiplatelet therapy.;Secondary Objective: Not applicable;Primary end point(s): Primary Efficacy Endpoint: Number of participants with symptomatic ischemic stroke or covert brain infarcts detected by MRI Primary Safety Endpoint: Time from randomization to first occurrence of International Society on Thrombosis and Hemostasis (ISTH) major bleeding and clinically relevant non-major (CRNM) bleeding;Timepoint(s) of evaluation of this end point: Primary Efficacy Endpoint: From baseline up to 6 months Primary Safety Endpoint: From baseline up to 12 months	—

Measure

Time frame

Main Objective: • To assess the dose response of 3 different doses of BAY 2433334 compared to placebo in reducing the composite of symptomatic ischemic strokes and covert brain infarcts detected by MRI as well as other cerebro- and cardiovascular endpoints in participants with an acute non-cardioembolic ischemic stroke and who are treated with antiplatelet therapy. • To evaluate whether the incidence of bleeding is similar for BAY 2433334 compared to placebo in participants with an acute non-cardioembolic ischemic stroke and who are treated with antiplatelet therapy.;Secondary Objective: Not applicable;Primary end point(s): Primary Efficacy Endpoint: Number of participants with symptomatic ischemic stroke or covert brain infarcts detected by MRI Primary Safety Endpoint: Time from randomization to first occurrence of International Society on Thrombosis and Hemostasis (ISTH) major bleeding and clinically relevant non-major (CRNM) bleeding;Timepoint(s) of evaluation of this end point: Primary Efficacy Endpoint: From baseline up to 6 months Primary Safety Endpoint: From baseline up to 12 months

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Secondary

Measure	Time frame
Secondary end point(s): Secondary Efficacy Endpoints: 1.Number of participants with composite of symptomatic ischemic stroke and covert brain infarcts detected by MRI, CV death, myocardial infarction and systemic embolism 2.Number of participants with covert brain infarcts detected by MRI 3.Time from randomization to first occurrence of symptomatic ischemic stroke 4.Time from randomization to first occurrence of symptomatic ischemic stroke, CV death, myocardial infarction 5.Time from randomization to first occurrence of symptomatic ischemic and hemorrhagic stroke 6.Time from randomization to first occurrence of disabling stroke (mRS=4) 7.Time from randomization to all-cause mortality Secondary Safety Endpoints 1. Time from randomization to first occurrence of all bleeding 2. Time from randomization to first occurrence of ISTH major bleeding 3. Time from randomization to first occurrence of ISTH CRNM bleeding 4. Time from randomization to first occurrence of ISTH minor bleeding 5. Time from randomization to first occurrence of Intracerebral hemorrhage (non-traumatic);Timepoint(s) of evaluation of this end point: From baseline up to 12 months	—

Measure

Time frame

Secondary end point(s): Secondary Efficacy Endpoints: 1.Number of participants with composite of symptomatic ischemic stroke and covert brain infarcts detected by MRI, CV death, myocardial infarction and systemic embolism 2.Number of participants with covert brain infarcts detected by MRI 3.Time from randomization to first occurrence of symptomatic ischemic stroke 4.Time from randomization to first occurrence of symptomatic ischemic stroke, CV death, myocardial infarction 5.Time from randomization to first occurrence of symptomatic ischemic and hemorrhagic stroke 6.Time from randomization to first occurrence of disabling stroke (mRS=4) 7.Time from randomization to all-cause mortality Secondary Safety Endpoints 1. Time from randomization to first occurrence of all bleeding 2. Time from randomization to first occurrence of ISTH major bleeding 3. Time from randomization to first occurrence of ISTH CRNM bleeding 4. Time from randomization to first occurrence of ISTH minor bleeding 5. Time from randomization to first occurrence of Intracerebral hemorrhage (non-traumatic);Timepoint(s) of evaluation of this end point: From baseline up to 12 months

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Countries

Australia, Austria, Belgium, Bulgaria, Canada, China, Czechia, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Poland, Portugal, Russian Federation, Slovakia, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

Public ContactBayer Clinical Trials Contact

Bayer

clinical-trials-contact@bayer.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026