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

Phase 1

• Conditions: Prevention of ischemic stroke in patients post acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack; MedDRA version: 20.0Level: PTClassification code 10049165Term: Cerebrovascular accident prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 22.1Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 100000004852; MedDRA version: 20.1Level: LLTClassification code 10072760Term: Transient ischemic attackSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2022-001067-27-CZ
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-25
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 9300

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified