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(19767 OCEANIC-AF) A multicenter, international, randomized, active comparator-controlled, double-blind, double-dummy, parallel-group, 2-arm, Phase 3 study to compare the efficacy and safety of the oral FXIa inhibitor asundexian (BAY 2433334) with apixaban for the prevention of stroke or systemic embolism in male and female participants aged 18 years and older with atrial fibrillation at risk for stroke

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503794-38-00
Acronym
19767
Enrollment
9578
Registered
2023-09-08
Start date
2022-11-24
Completion date
2024-01-23
Last updated
2023-10-26

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

Conditions

Prevention of stroke or systemic embolism in atrial fibrillation

Brief summary

Time to first occurrence of composite of stroke or systemic embolism, Time to first occurrence of ISTH major bleeding, Time to first occurrence of composite of stroke, systemic embolism, or ISTH major bleeding

Detailed description

Time to first occurrence of composite of ischemic stroke or systemic embolism, Time to first occurrence of all-cause mortality, Time to first occurrence of ischemic stroke, Time to first occurrence of cardiovascular (CV) death, Time to first occurrence of composite of CV death, stroke, or myocardial infarction, Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding, Time to first occurrence of clinically relevant non-major bleeding, Time to first occurrence of hemorrhagic stroke, Time to first occurrence of intracranial hemorrhage, Time to first occurrence of fatal bleeding, Time to first occurrence of minor bleeding, Time to first occurrence of composite of stroke, systemic embolism, ISTH major bleeding, or all-cause mortality, Time to first occurrence of composite of disabling stroke (modified Rankin Scale (mRS) >=3), critical bleeding, or all-cause mortality

Interventions

DRUGPlacebo for comparator product Apixaban 5mg
DRUGPlacebo for comparator product Apixaban 2.5mg

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 composite of stroke or systemic embolism, Time to first occurrence of ISTH major bleeding, Time to first occurrence of composite of stroke, systemic embolism, or ISTH major bleeding

Secondary

MeasureTime frame
Time to first occurrence of composite of ischemic stroke or systemic embolism, Time to first occurrence of all-cause mortality, Time to first occurrence of ischemic stroke, Time to first occurrence of cardiovascular (CV) death, Time to first occurrence of composite of CV death, stroke, or myocardial infarction, Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding, Time to first occurrence of clinically relevant non-major bleeding, Time to first occurrence of hemorrhagic stroke, Time to first occurrence of intracranial hemorrhage, Time to first occurrence of fatal bleeding, Time to first occurrence of minor bleeding, Time to first occurrence of composite of stroke, systemic embolism, ISTH major bleeding, or all-cause mortality, Time to first occurrence of composite of disabling stroke (modified Rankin Scale (mRS) >=3), critical bleeding, or all-cause mortality

Countries

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

Outcome results

None listed

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