A study to learn more about asundexian for prevention of stroke in male and female participants 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.

Phase 3 study to investigate the efficacy and safety of the oral FXIa inhibitor Asundexian (BAY 2433334) compared with placebo in participants after an acute noncardio embolic ischemic stroke or high-risk TIA.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061517

Enrollment

9300

Registered

2024-01-16

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Health Condition 1: I699- Sequelae of unspecified cerebrovascular diseases

Interventions

Intervention1: Asundexian BAY 2433334 Film-coated tablet : 50 mg, orally, once daily up to 31 months Control Intervention1: Placebo to Asundexian BAY 2433334 Film-coated tablet : 50 mg, orally, once

Eligibility

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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 non cardioembolic ischemic stroke or high-risk TIATimepoint: Up to 31 months	—

Measure

Time frame

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 non cardioembolic ischemic stroke or high-risk TIATimepoint: Up to 31 months

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Secondary

Measure	Time frame
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 endpointsTimepoint: Up to 31 months	—

Measure

Time frame

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 endpointsTimepoint: Up to 31 months

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Countries

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

Contacts

Public ContactAnand Pendse

Bayer Pharmaceuticals Private Limited

anand.pendse@bayer.com919820563905

Outcome results

None listed

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