NCT07430956招募中3 期
A Master Protocol for a Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention With REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, Versus Placebo in Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable (ROXI-INCLINE)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 2,628
- 试验地点
- 35
- 主要终点
- Time to first occurrence of ischemic stroke or systemic embolism
研究概览
简要总结
This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called "study drugs"). The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly. When this happens, blood cannot move smoothly through the heart; it can slow down or pool in one spot, which can lead to the formation of blood clots.
REGN7508 and REGN9933 are designed to help stop blood clots forming in patients with atrial fibrillation. The aim of the study is to see how effective and safe REGN7508 and REGN9933, individually, are in preventing ischemic stroke or systemic embolism in people with atrial fibrillation who cannot or may choose to not take blood thinners.
The study is looking at several other research questions, including:
- What side effects may happen from taking REGN7508 or REGN9933
- How well does REGN7508 or REGN9933 lower the risk of having an ischemic stroke and/or systemic embolism compared to the placebo
- How well does REGN7508 or REGN9933 lower the risk of having a major health problem affecting heart and blood circulation compared to placebo
- How well does REGN7508 or REGN9933 lower the risk of death compared to placebo
- How much REGN7508 or REGN9933 is in the blood at different times
- Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the study drugs 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
- •At moderate to high risk for stroke defined as:
- •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 ≥4 OR
- •CHA2DS2-VA score of 3 AND at least 1 enrichment criteria as described in the protocol
- •Shared decision making between the participant and provider determining that the bleeding risk of Oral Anticoagulant (OAC) therapy outweighs the benefits, making the participant unsuitable for OAC therapy as described in the protocol
排除标准
- •Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)
- •Had an ischemic stroke within 2 days prior to randomization
- •Has persistent, uncontrolled hypertension (per investigator's discretion)
- •Has a history of Central Nervous System (CNS) bleeding within 30 days prior to randomization
- •Has a life expectancy less than 12 months
- •Has participated in a prior Factor XI (FXI) inhibitor study
- •Note: Other protocol-defined Inclusion/ Exclusion criteria apply
研究组 & 干预措施
REGN7508
Experimental
干预措施: REGN7508 (Drug)
REGN9933
Experimental
干预措施: REGN9933 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time to first occurrence of ischemic stroke or systemic embolism
时间窗: Up to 36 months
Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding
时间窗: Up to 36 months
次要结局
- Time to first occurrence of Major Adverse Cardiovascular Event (MACE)(Up to 36 months)
- Time to first occurrence of MACE, pulmonary embolism, or Venous Thromboembolism (VTE)(Up to 36 months)
- Time to first occurrence of ischemic stroke(Up to 36 months)
- Time to Cardiovascular (CV) death(Up to 36 months)
- Time to all-cause death(Up to 36 months)
- Occurrence of Treatment-Emergent Adverse Events (TEAEs)(Up to 39 months)
- Severity of TEAEs(Up to 39 months)
- Concentrations of REGN7508 over time(Up to 36 months)
- Concentrations of REGN9933 over time(Up to 36 months)
- Change from baseline in activated Partial Thromboplastin Time (aPTT) over time(Up to approximately 9 weeks)
- Change from baseline in Prothrombin time (PT)/International Normalized Ratio (INR) over time(Up to approximately 9 weeks)
- Occurrence of Anti-Drug Antibody (ADA) to REGN7508 over time(Up to 36 months)
- Magnitude of ADA to REGN7508 over time(Up to 36 months)
- Occurrence of ADA to REGN9933 over time(Up to 36 months)
- Magnitude of ADA to REGN9933 over time(Up to 36 months)
研究者
研究点 (35)
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