Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation

Korábbi kezelés

• Has had a successful ablation therapy without documented recurrent AF or a participant after Left Atrial Appendage (LAA) occlusion/exclusion or plan for ablation or LAA occlusion/exclusion within the next 6 months starting from randomization
• Had an ischemic stroke within 2 days prior to randomization

Más betegség

• Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)
• Has persistent, uncontrolled hypertension (per investigator's discretion)

Laborértékek

• Has estimated Glomerular Filtration Rate (eGFR) <15 mL/min/1.73m2 within 30 days prior to randomization or is on dialysis or expected to be started on dialysis within the next 6 months starting from randomization
  • Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Egyéb

• Has known moderate-to-severe mitral stenosis

• Has AF or flutter (paroxysmal or persistent), not considered 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 Systemic embolism (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 Normalized Ratio (INR) <2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA)