Randomized Comparison of Efficacy and Safety of High-intensity Rosuvastatin/Ezetimibe Combination Versus Treat-to-target Rosuvastatin Monotherapy for Patients With Peripheral Artery or Polyvascular Disease (CARE-PVD Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,462
- 试验地点
- 1
- 主要终点
- Composite of Major cardiovascular event or major adverse limb event
研究概览
简要总结
Patients with atherosclerotic peripheral artery disease often have combined coronary artery disease or cerebral artery disease and show high rates of cardiovascular mortality and morbidities. Therefore, secondary prevention for these patients is of great clinical importance. Currently, Korean, US, and European guidelines recommend different LDL cholesterol target goals in patients with peripheral artery disease. In recent clinical trials, combination therapy of statin plus ezetimibe demonstrated improved cardiovascular outcomes compared with statin monotherapy. Thus, the purpose of the CARE-PVD study is to investigate whether the combination therapy of high intensity rosuvastatin 20 mg plus ezetimibe 10 mg can improve cardiovascular outcomes in patient with peripheral artery disease or polyvascular artery disease in comparison with rosuvastatin treat-to-target (LDL cholesterol <70 mg/dL) monotherapy.
详细描述
- A multicenter prospective randomized controlled clinical trial
- A total of 2462 subjects with cperipheral artery disease or polyvascular disease will be included according to inclusion and exclusion criteria.
- Patients will be randomized in a 1:1 manner into the rosuvastatin/ezetimibe combination therapy group or rosuvastatin monotherapy group. • The randomization will be startified by previous use of statin and presence of diabetes mellitus. • In the rosuvastatin/ezetimibe combination therapy group, rosuvastatin 20 mg plus ezetimibe 10 mg will be administered. • In the rosuvastatin monotherapy group, rosuvastatin will be administered and the dose of rosuvastatin will be adjusted to attain the target LDL cholesterol level < 70 mg/dL.
- Patients will be followed clinically for 3years.
- The primary endpoint is defined as the composite of Major cardiovascular event (MACE) or major adverse limb event (MALE) at 3-year follow-up.
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
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rosuvastatin/ezetimibe combination therapy
Combination therapy of high-intensity dose rosuvastatin and ezetimibe
干预措施: Combination therapy of high-intensity dose rosuvastatin and ezetimibe (Drug)
Rosuvastatin monotherapy
Rosuvastatin monotherapy for treat-to-target (LDL cholesterol < 70 mg/dL)
干预措施: Rosuvastatin monotherapy for treat-to-target (Drug)
结局指标
主要结局
Composite of Major cardiovascular event or major adverse limb event
时间窗: at 3 years
Composite of Major cardiovascular event (MACE) or major adverse limb event (MALE) at 3-year follow-up MACE includes death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and hospitalization for unstable angina or heart failure. MALE includes acute lower extremity ischemia, major lower extremity amputation, and revascularization of lower extremity arteries.
次要结局
- discontinuation of lipid lowering therapy(at 1, 2, and 3 years)
- Major cardiovascular event(death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and hospitalization for unstable angina or heart failure)(at 1, 2, and 3 years)
- Major adverse limb event(acute lower extremity ischemia, major lower extremity amputation, and revascularization of lower extremity arteries)(at 1, 2, and 3 years)
- adverse clinical events related to lipid lowering therapy(at 1, 2, and 3 years)
- attainment of LDL cholesterol(at 1, 2, and 3 years)
- Major cardiovascular event : non-fatal myocardial infarction(at 1, 2, and 3 years)