NCT07318610招募中3 期
A Master Protocol for a Phase 3, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, in Participants With Recent Lower Extremity Revascularization for Symptomatic Peripheral Artery Disease (ROXI-PALISADE)
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 7,050
- 试验地点
- 17
- 主要终点
- Time-to-first occurrence of a major thrombotic vascular event, consisting of Acute Limb Ischemia (ALI), major amputation (above the ankle) of vascular etiology, Myocardial Infarction (MI), ischemic stroke, or Cardiovascular (CV) death
研究概览
简要总结
This study is researching 2 different experimental drugs called REGN7508 and REGN9933. The study is focused on people who have Peripheral Artery Disease (PAD), which means that the blood vessels in their arms and legs have become too narrow. People with PAD have a higher risk of getting blood clots after procedures like Lower Extremity Revascularization (LER), a procedure to improve blood flow in the legs and feet.
The aim of this study is to see how well REGN7508 and REGN9933 prevent life-threatening blood clots in participants with PAD who have recently had LER. The effects of REGN7508 and REGN9933, individually, will also be compared to rivaroxaban and a placebo.
The study is looking at several other research questions, including:
- What side effects might happen from taking the study drugs and how do they compare to the side effects of rivaroxaban
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)
- If the study drugs affect the ability of the blood to clot normally
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Cohort 1 of this study is double-blinded, and for Cohort 2 the participants, sponsor, and the investigators will be blinded to REGN7508 or REGN9933, but rivaroxaban will be administered as open-label.
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
- •Successful LER distal to the external iliac artery for ischemia due to atherosclerotic disease within 10 days prior to randomization as described in the protocol
- •At least 1 of the following enrichment factors for major thrombotic vascular events:
- •Bypass with prosthetic graft
- •Endovascular treatment with stenting
- •Target lesion length >15 cm
- •History of LER or amputation for PAD prior to qualifying LER
- •Type 2 diabetes mellitus requiring pharmacologic treatment
- •Comorbid symptomatic coronary artery disease as described in the protocol
- •Chronic kidney disease as described in the protocol
- •Age ≥75 years
排除标准
- •Has any active clinical condition requiring chronic therapeutic anticoagulation after the index revascularization including known triple positive antiphospholipid syndrome
- •Has known bleeding diathesis, platelet count <50,000/mm^3 or history of non-traumatic intracerebral hemorrhage, known cerebral amyloid angiopathy, or known unrepaired cerebrovascular malformations
- •Has recent coronary revascularization as described in the protocol
- •For Cohort 2 only: Has estimated Glomerular Filtration Rate (eGFR) <15 mL/min/1.73m^2 within 14 days prior to randomization or on dialysis or expected to be started on dialysis within the next 12 weeks starting from randomization
- •Has any other condition or therapy which would make the participant unsuitable for this study or not allow participation for the full planned study period
- •Has allergy, hypersensitivity, or other contraindication to REGN7508, REGN9933, or rivaroxaban (Cohort 2 only) or their excipients
- •Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
研究组 & 干预措施
Cohort 2
Experimental
干预措施: Rivaroxaban (Drug)
Cohort 1
Experimental
干预措施: Placebo (Drug)
Cohort 2
Experimental
干预措施: REGN9933 (Drug)
Cohort 2
Experimental
干预措施: REGN7508 (Drug)
Cohort 1
Experimental
干预措施: REGN9933 (Drug)
Cohort 1
Experimental
干预措施: REGN7508 (Drug)
结局指标
主要结局
Time-to-first occurrence of a major thrombotic vascular event, consisting of Acute Limb Ischemia (ALI), major amputation (above the ankle) of vascular etiology, Myocardial Infarction (MI), ischemic stroke, or Cardiovascular (CV) death
时间窗: Approximately up to 42 months
Cohort 1
Time-to-first occurrence of International Society of Thrombosis and Hemostasis (ISTH) major or Clinically Relevant Non-major (CRNM) bleeding
时间窗: Approximately up to 42 months
Cohort 1 and 2
次要结局
- Time-to-first occurrence of vascular hospitalization for a coronary cerebrovascular, or peripheral event of thrombotic nature(Approximately up to 42 months)
- Time-to-first occurrence of Major Adverse Limb Event (MALE)(Approximately up to 42 months)
- Time-to-first occurrence of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke or coronary death(Approximately up to 42 months)
- Time-to-first occurrence of vascular hospitalization for a coronary or peripheral event of thrombotic nature(Approximately up to 42 months)
- Time-to-all-cause mortality(Approximately up to 42 months)
- Total (first and subsequent) occurrences of major thrombotic vascular events, consisting of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke, or CV death(Approximately up to 42 months)
- Time-to-first occurrence of an expanded thrombotic vascular event, consisting of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke, CV death, unplanned index limb revascularization, or Venous Thromboembolism (VTE)(Approximately up to 42 months)
- Time-to-first occurrence of ALI, major amputation of vascular etiology, MI, ischemic stroke, or all-cause mortality(Approximately up to 42 months)
- Time-to-first occurrence of unplanned index limb revascularization for ischemia(Approximately up to 42 months)
- Occurrence of Treatment-Emergent Adverse Event (TEAEs)(Approximately up to 45 months)
- Total (first and subsequent) occurrences of ALI, major amputation (above the ankle) of vascular etiology, MI, all-cause stroke, or CV death(Approximately up to 42 months)
- Total (first and subsequent) occurrences of ALI, major amputation (above the ankle) of vascular etiology, MI, all-cause stroke, CV death, unplanned index limb revascularization, or VTE(Approximately up to 42 months)
- Time-to-first occurrence of VTE(Approximately up to 42 months)
- Occurrence of ADA to REGN9933 over time(Approximately up to 45 months)
- Concentrations of REGN7508 over time(Approximately up to 45 months)
- Concentrations of REGN9933 over time(Approximately up to 45 months)
- Change from baseline in Prothrombin Time (PT)/International Normalization Ratio (INR) over time(Approximately up to week 9)
- Time-to-first occurrence of Major Adverse Cardiovascular Event (MACE)(Approximately up to 42 months)
- Time-to-first occurrence of a major thrombotic vascular event or ISTH fatal/critical organ bleeding (net clinical benefit)(Approximately up to 42 months)
- Severity of TEAEs(Approximately up to 45 months)
- Magnitude of ADA to REGN9933 over time(Approximately up to 45 months)
- Change from baseline in activated Partial Thromboplastin Time (aPTT) over time(Approximately up to week 9)
- Time-to-first occurrence of Thrombolysis in Myocardial Infarction (TIMI) major bleeding(Approximately up to 42 months)
- Occurrence of Anti-Drug Antibody (ADA) to REGN7508 over time(Approximately up to 45 months)
- Time-to-first occurrence of a major thrombotic vascular event(Approximately up to 42 months)
- Magnitude of ADA to REGN7508 over time(Approximately up to 45 months)
- Total (first and subsequent) occurrences of expanded thrombotic vascular events(Approximately up to 42 months)
研究者
研究点 (17)
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