Clinical Trials Administrator

CONTACT

Lead Sponsor

Regeneron Pharmaceuticals

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•1. 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
•2. Meets one of the following:
•1. 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
•2. CHA2DS2-VA score ≥3 OR
•3. CHA2DS2-VA score of 2 AND at least 1 enrichment criteria as described in the protocol
•3. Must have an International Normalized Ratio (INR) \<2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA)

•1. Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)
•2. Has known moderate-to-severe mitral stenosis
•3. 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
•4. Had an ischemic stroke within 2 days prior to randomization
•5. Has persistent, uncontrolled hypertension (per investigator's discretion)
•6. 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

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