JPRN-jRCT2061220080CompletedPhase 3
multicenter, international, randomized, active comparator-controlled, doubleblind, 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 - OCEANIC-AF
Myoishi Masashi0 sites18,000 target enrollmentStarted: December 29, 2022Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 18,000
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •18 years of age or older (at legal age of consent according to local legislation) at the time of signing the informed consent
- •- Atrial fibrillation documented by ECG evidence with an indication for indefinite treatment with an oral anticoagulant
- •- CHA2DS2-VASc score >= 3 if male or >= 4 if female,
- •CHA2DS2-VASc score of 2 if male or 3 if female and enrichment criteria.
Exclusion Criteria
- •- Mechanical heart valve prosthesis
- •- Moderate-to-severe mitral stenosis at the time of inclusion into the study
- •- Atrial fibrillation only due to reversible cause
- •- Requirement for chronic anticoagulation for a different indication than AF
Investigators
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