Effect of Intensive LDL-cholesterol Targeting for Elderly Patients With Cardiovascular Disease: I-OLD Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Clinical efficacy of intensive lipid-lowering therapy
研究概览
简要总结
Although there have been studies regarding intensive lowering of low-density lipoprotein (LDL)-cholesterol with high intensity statins in patients with cardiovascular disease, elderly patients were either excluded or accounted only a small portion of study subjects. Therefore, this study sought to compare the clinical outcomes according to the LDL-cholesterol therapy strategy (intensive targeting [LDL-cholesterol goal of <55mg/dL] vs. conventional therapy [moderate intensity statin therapy]) in elderly patients with ≥75 years and documented cardiovascular disease.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥75 years
- •Documented atherosclerotic cardiovascular disease (at least 1 of the following) A. Previous acute coronary syndrome (MI or unstable angina) B. Or stable angina with imaging studies of coronary artery disease or functional studies of myocardial ischemia C. Or coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft) D. Or peripheral artery disease.
排除标准
- •MI or stroke within 1 year
- •LDL-cholesterol level less than 55 mg/dL without statin therapy
- •Active liver disease or persistent unexplained serum AST/ALT elevation more than 2 times the upper limit of normal range
- •Allergy or hypersensitivity to any statin
- •Life expectancy less than 1 years
- •Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
研究组 & 干预措施
Intensive targeting group
Intensive lipid loweroing therapy with LDL-cholesterol goal of <55mg/dL
干预措施: Intensive targeting group (Drug)
Conventional therapy group
Initiate and maintain moderate intensity statin therapy
干预措施: Conventional therapy group (Drug)
结局指标
主要结局
Clinical efficacy of intensive lipid-lowering therapy
时间窗: 3 years
Primary Outcome - Composite of cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, coronary revascularization, and hospitalization for unstable angina
次要结局
- Efficacy endpoint(3 years)
- Safety endpoint(3 years)