OCEANIC-AF

Official Title

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

Study Purpose

Phase 3 study to investigate the efficacy and safety of the oral factor XIa (FXIa) inhibitor asundexian (BAY 2433334) compared with apixaban in participants with atrial fibrillation at risk for stroke

Diagnosis

Eligibility

CHA2DS2-VASc score ≥ 3 if male or ≥ 4 if female

OR

CHA2DS2-VASc score of 2 if male or 3 if female and at least one of the following criteria:

• age ≥ 70
• previous stroke, transient ischemic attack, or systemic embolism
• renal dysfunction with eGFR < 50 ml/min within 14 days prior to randomization
• prior episode of non-traumatic major bleeding
• current single agent antiplatelet therapy planned to continue for at least 6 months after randomization
• ≤ 6 consecutive weeks of treatment with oral anticoagulant prior to randomization.

Excluded if:

• Mechanical heart valve
• Moderate – sever mitral stenosis
• Atrial fibrillation only due to reversible cause
• Planed or recent LAA occlusion or ablation
• Bleeding disorder
• Recent stroke
• Known liver disease
• Severe kidney disease or known/expected dialysis
• Recent major surgery

Intervention

asundexian (BAY 2433334) vs apixaban