Oceanic AF: A multicenter, international, randomized, active comparator-controlled, double-blind, doubledummy, 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.
The main purpose of this study is to collect more data about how well asundexian works to prevent stroke and systemic embolism and how safe it is compared to apixaban in people with atrial fibrillation and at high risk for stroke.
- 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, OR CHA2DS2-VASc score of 2 if male or 3 if female and enrichment 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