NCT07175428招募中2 期
A Phase 2, Randomized, Multicenter, Open-label, Blinded-endpoint Study to Evaluate the Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against FXI, Versus Apixaban in Participants With Atrial Fibrillation (ROXI-ATLAS)
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 98
- 主要终点
- Incidence of any bleeding
研究概览
简要总结
This study is researching experimental drugs called REGN7508 and REGN9933. The study is focused on participants who have atrial fibrillation, which means that the heart beats too fast and unevenly. 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 well REGN7508 and REGN9933 work in patients that get medicine for their atrial fibrillation. The bleeding effects of REGN7508 and REGN9933 will be compared to another medicine (apixaban), which is available on the market to treat and prevent formation of blood clots.
The study is looking at several other research questions, including:
- What side effects may happen from taking REGN7508 or REGN9933
- How well do the study drugs reduce the risk of having a stroke
- How much of REGN7508 or REGN9933 is in the blood at different times
- Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the 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
- Single (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 felt 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 Thromboembolism (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 Normalization 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 successful ablation therapy or Left Atrial Appendage (LAA) occlusion/exclusion, or planned ablation or LAA occlusion/exclusion as described in the protocol
- •Had an ischemic stroke within 2 days prior to randomization
- •Has estimated Glomerular Filtration Rate (eGFR) <15 mL/min/1.73m^2 within 30 days prior to randomization or on dialysis or expected to be started as described in the protocol
- •Has a history of central nervous system bleeding within 30 days prior to randomization
- •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)
Apixaban
Active Comparator
干预措施: Apixaban (Drug)
结局指标
主要结局
Incidence of any bleeding
时间窗: 12 weeks
Defined as the composite of International Society on Thrombosis and Haemostasis (ISTH) major bleeding, ISTH Clinically Relevant Non-Major (CRNM) bleeding, or minor bleeding
次要结局
- Incidence of ISTH CRNM bleeding(12 weeks)
- Incidence of minor bleeding(12 weeks)
- Number of ISTH major bleeding events(12 weeks)
- Number of ISTH CRNM bleeding events(12 weeks)
- Number of minor bleeding events(12 weeks)
- Incidence of the composite of ISTH major bleeding or ISTH CRNM bleeding(12 weeks)
- Incidence of ISTH major bleeding(12 weeks)
- Incidence of Treatment-Emergent Adverse Events (TEAEs)(Approximately 25 weeks)
- Severity of TEAEs(Approximately 25 weeks)
- Incidence of the composite of stroke or systemic embolism(Approximately 12 weeks)
- Incidence of Antidrug Antibodies (ADA) to REGN7508(12 weeks)
- Magnitude of ADA to REGN7508(12 weeks)
- Incidence of ADA to REGN9933(12 weeks)
- Magnitude of ADA to REGN9933(12 weeks)
- Concentrations of REGN7508(Approximately 25 weeks)
- Concentrations of REGN9933(Approximately 25 weeks)
- Change from baseline in activated Partial Thromboplastin Time (aPTT)(Approximately 25 weeks)
- Change from baseline in Prothrombin Time (PT)(Approximately 25 weeks)
研究者
研究点 (98)
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