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(20604 OCEANIC STROKE) A multicenter, 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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503793-20-00
Acronym
20604
Enrollment
5223
Registered
2023-09-27
Start date
2023-01-18
Completion date
2025-10-23
Last updated
2025-10-29

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

Brief summary

Time to first occurrence of ischemic stroke, Time to first occurrence of ISTH major bleeding

Detailed description

Time to first occurrence of all strokes (ischemic and hemorrhagic), Time to first occurrence of composite of Cardiovascular (CV) death, myocardial infarction (MI) or stroke, Time to first occurrence of composite of all-cause mortality, MI or stroke, Time to first occurrence of disabling stroke (mRS >= 3 at 90 days), Time to first occurrence of all-cause mortality, Time to first occurrence of transient ischemic attack (TIA), Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding, Time to first occurrence of ISTH clinically relevant non-major bleeding, Time to first occurrence of symptomatic intracranial hemorrhage, Time to first occurrence of hemorrhagic stroke, Time to first occurrence of fatal bleeding, Time to first occurrence of minor bleeding, Time to first occurrence of composite of ischemic stroke or ISTH major bleeding, Time to first occurrence of composite of CV death, all stroke, MI or ISTH major bleeding, Time to first occurrence of composite of all-cause mortality, disabling stroke, fatal bleeding, symptomatic intracranial hemorrhage, Time to first occurrence of ischemic stroke in the first 90 days

Interventions

Sponsors

Bayer AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to first occurrence of ischemic stroke, Time to first occurrence of ISTH major bleeding

Secondary

MeasureTime frame
Time to first occurrence of all strokes (ischemic and hemorrhagic), Time to first occurrence of composite of Cardiovascular (CV) death, myocardial infarction (MI) or stroke, Time to first occurrence of composite of all-cause mortality, MI or stroke, Time to first occurrence of disabling stroke (mRS >= 3 at 90 days), Time to first occurrence of all-cause mortality, Time to first occurrence of transient ischemic attack (TIA), Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding, Time to first occurrence of ISTH clinically relevant non-major bleeding, Time to first occurrence of symptomatic intracranial hemorrhage, Time to first occurrence of hemorrhagic stroke, Time to first occurrence of fatal bleeding, Time to first occurrence of minor bleeding, Time to first occurrence of composite of ischemic stroke or ISTH major bleeding, Time to first occurrence of composite of CV death, all stroke, MI or ISTH major bleeding, Time to first occurrence of comp

Countries

Austria, Belgium, Bulgaria, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026