A Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention with REGN7508, a Monoclonal Antibody Against Factor XI, Versus Apixaban in Participants with Atrial Fibrillation (ROXI-EVEREST)

未提供0 个研究点目标入组 1,552 人开始时间: 待定

适应症

试验速览

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•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:
•a. 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) naive OR
•b. CHA2DS2-VA score >=3 OR
•c. 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)
•Note: Other protocol-defined Inclusion criteria apply

•Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)
•Has known moderate-to-severe mitral stenosis
•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
•Has persistent, uncontrolled hypertension (per investigator's discretion)
•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 Exclusion criteria apply

发起方

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