Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation

Key Inclusion Criteria:

• Has AF or flutter (paroxysmal or persistent), not felt to be secondary to a reversible cause, and an indication for indefinite anticoagulation treatment as described in the protocol
• Meets one of the following:

• CHA2DS2-VA [C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Thromboembolism (double points); V: Vascular disease; A: Age 65-74 years] score ≥2 and Oral Anticoagulant (OAC) naïve or
• CHA2DS2-VA score ≥3 or
• CHA2DS2-VA score of 2 and at least 1 enrichment criteria as described in the protocol
• Must have an International Normalization Ratio (INR) <2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA)

Key Exclusion Criteria:

• Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)
• Has known moderate-to-severe mitral stenosis
• Has had successful ablation therapy or Left Atrial Appendage (LAA) occlusion/exclusion, or planned ablation or LAA occlusion/exclusion as described in the protocol
• Had an ischemic stroke within 2 days prior to randomization
• Has estimated Glomerular Filtration Rate (eGFR) <15 mL/min/1.73m^2 within 30 days prior to randomization or on dialysis or expected to be started as described in the protocol
• Has a history of central nervous system bleeding within 30 days prior to randomization

Note: Other protocol-defined Inclusion/ Exclusion criteria apply