NCT07626411招募中3 期
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)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 15,364
- 试验地点
- 32
研究概览
简要总结
This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called apixaban. The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly.
The aim of the study is to see how safe and effective REGN7508 is in preventing stroke and/or systemic embolism in participants with atrial fibrillation and how it compares against participants that will receive apixaban in this study.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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 Inclusion/ Exclusion criteria apply
研究组 & 干预措施
REGN7508 + Placebo
Experimental
干预措施: REGN7508 (Drug)
Apixaban + Placebo
Active Comparator
干预措施: Apixaban (Drug)
REGN7508 + Placebo
Experimental
干预措施: Placebo (Drug)
Apixaban + Placebo
Active Comparator
干预措施: Placebo (Drug)
研究者
研究点 (32)
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