A study to learn more about asundexian (also called BAY2433334) for prevention of ischemic stroke in male and female participants aged 18 years and older who already had such a stroke due to a blood clot that formed outside the heart and travelled to the brain, or temporary stroke-like symptoms

A multicenter, international, randomized, placebo controlled, double-blind, parallel group and event driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA - Oral faCtor Eleven A iNhibitor asundexIan as novel anti-thrombotiC – STROKE study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-001067-27-FI

Enrollment

9300

Registered

2022-10-24

Start date

2022-12-29

Completion date

Unknown

Last updated

2024-02-26

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

Conditions

Prevention of ischemic stroke in patients post acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack MedDRA version: 20.0 Level: PT Classification code 10049165 Term: Cerebrovascular accident prophylaxis System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 22.1 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 100000004852 MedDRA version: 20.1 Level: LLT Classification code 10072760 Term: Transient ischemic att

Interventions

Product Name: Asundexian Product Code: BAY 2433334 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Asundexian CAS Number: 2064121-65-7 Current Sponsor code: BAY 2433334 Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants must be = 18 years of age 2. Acute non-cardioembolic stroke or high-risk TIA 3. Systemic or cerebrovascular atherosclerosis or acute non-lacunar infarct 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 3100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6200

Exclusion criteria

Exclusion criteria: 1. Ischemic stroke = 7 days before the index stroke event 2. Index stroke following procedures or strokes due to other rare causes 3. History of atrial fibrillation/flutter, left ventricular thrombus, mechanic valve or other cardioembolic source of stroke requiring anticoagulation

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy To evaluate whether the oral FXIa inhibitor asundexian is superior to placebo on top of background antiplatelet therapy in reducing ischemic stroke in patients after an acute non-cardioembolic ischemic stroke or high-risk Transient ischemic attack (TIA) Safety To compare the incidence of International Society on Thrombosis and Hemostasis (ISTH) major bleeding for asundexian and placebo on top of antiplatelet therapy in patients after an acute noncardioembolic ischemic stroke or high-risk TIA;Secondary Objective: Efficacy To evaluate whether asundexian is superior to placebo on top of antiplatelet therapy in reducing the occurrence of composite and individual efficacy endpoints Safety To compare asundexian and placebo on top of antiplatelet therapy with respect to individual bleeding endpoints Net clinical benefit To further compare the benefit and risk of asundexian and placebo with respect to a composite of efficacy and safety endpoints;Primary end point(s): 1. Time to first occurrence of ischemic stroke 2. Time to first occurrence of ISTH major bleeding;Timepoint(s) of evaluation of this end point: Up to 31 months	—

Measure

Time frame

Main Objective: Efficacy To evaluate whether the oral FXIa inhibitor asundexian is superior to placebo on top of background antiplatelet therapy in reducing ischemic stroke in patients after an acute non-cardioembolic ischemic stroke or high-risk Transient ischemic attack (TIA) Safety To compare the incidence of International Society on Thrombosis and Hemostasis (ISTH) major bleeding for asundexian and placebo on top of antiplatelet therapy in patients after an acute noncardioembolic ischemic stroke or high-risk TIA;Secondary Objective: Efficacy To evaluate whether asundexian is superior to placebo on top of antiplatelet therapy in reducing the occurrence of composite and individual efficacy endpoints Safety To compare asundexian and placebo on top of antiplatelet therapy with respect to individual bleeding endpoints Net clinical benefit To further compare the benefit and risk of asundexian and placebo with respect to a composite of efficacy and safety endpoints;Primary end point(s): 1. Time to first occurrence of ischemic stroke 2. Time to first occurrence of ISTH major bleeding;Timepoint(s) of evaluation of this end point: Up to 31 months

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Secondary

Measure	Time frame
Secondary end point(s): 1. Time to first occurrence of all strokes (ischemic and hemorrhagic) 2. Time to first occurrence of composite of Cardiovascular (CV) death, myocardial infarction (MI) or stroke 3. Time to first occurrence of composite of all-cause mortality, MI or stroke 4. Time to first occurrence of disabling stroke (mRS =3 at 90 days) 5. Time to first occurrence of all-cause mortality 6. Time to first occurrence of transient ischemic attack (TIA) 7. Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding 8. Time to first occurrence of ISTH clinically relevant non-major bleeding 9. Time to first occurrence of symptomatic intracranial hemorrhage 10. Time to first occurrence of hemorrhagic stroke 11. Time to first occurrence of fatal bleeding 12. Time to first occurrence of minor bleeding 13. Time to first occurrence of composite of ischemic stroke or ISTH major bleeding 14. Time to first occurrence of composite of CV death, all stroke, MI or ISTH major bleeding 15. Time to first occurrence of composite of all-cause mortality, disabling stroke, fatal bleeding, symptomatic intracranial hemorrhage;Timepoint(s) of evaluation of this end point: Up to 31 months	—

Measure

Time frame

Secondary end point(s): 1. Time to first occurrence of all strokes (ischemic and hemorrhagic) 2. Time to first occurrence of composite of Cardiovascular (CV) death, myocardial infarction (MI) or stroke 3. Time to first occurrence of composite of all-cause mortality, MI or stroke 4. Time to first occurrence of disabling stroke (mRS =3 at 90 days) 5. Time to first occurrence of all-cause mortality 6. Time to first occurrence of transient ischemic attack (TIA) 7. Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding 8. Time to first occurrence of ISTH clinically relevant non-major bleeding 9. Time to first occurrence of symptomatic intracranial hemorrhage 10. Time to first occurrence of hemorrhagic stroke 11. Time to first occurrence of fatal bleeding 12. Time to first occurrence of minor bleeding 13. Time to first occurrence of composite of ischemic stroke or ISTH major bleeding 14. Time to first occurrence of composite of CV death, all stroke, MI or ISTH major bleeding 15. Time to first occurrence of composite of all-cause mortality, disabling stroke, fatal bleeding, symptomatic intracranial hemorrhage;Timepoint(s) of evaluation of this end point: Up to 31 months

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Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czechia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, 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