Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13,054
- 试验地点
- 2
- 主要终点
- Occurrence of one of following events(Cardiovascular death, Non-fatal Myocardial Infarction (MI), Non-fatal Cerebral Infarction (CI), Unstable angina requiring urgent hospitalization)
研究概览
简要总结
The purpose of this study is to evaluate the prevention of cardiovascular disease by moderate cholesterol lowering therapy, pitavastatin 1mg/day or aggressive cholesterol lowering therapy, pitavastatin 4mg/day in patients with stable coronary artery disease.
详细描述
It was already demonstrated by previous clinical trials that statins lower the incidence of death and cardiovascular events in patients with coronary artery disease. However, whether aggressive cholesterol lowering therapy, using high dosage of statins, is more effective than moderate cholesterol lowering therapy for the prevention of cardiovascular events in patients with coronary artery disease has not been studied in Japan.
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
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who met following all criteria are entered in run-in period, loading pitavastatin 1 mg/day for more than 1 month when informed consent was given. (Primary registration)
- •Coronary artery disease patients meeting one of the following events
- •History of Acute Coronary Syndrome (AMI or Unstable angina)
- •History of revascularization (PCI or CABG)
- •Diagnosis of ischemic heart disease and coronary artery stenosis as having 75% or higher stenosis according to the AHA classification
- •Hypercholesterolemia patients meeting one of following criteria
- •LDL-C is 140 mg/dL or over
- •LDL-C is 100 mg/dL or over and requiring cholesterol lowering drugs judged by attending physicians
- •Patents receiving cholesterol lowering drugs
- •Age (≧20 <80 year-old)
- •Patients given written informed consent.
排除标准
- •Exclusion Criteria(Pre-Run-in period)
- •Patients planning revascularization
- •Malignant tumor in active phase
- •Patients who meet contraindication of LIVALO tablet below
- •Patients who have hypersensitivity to LIVALO tablet
- •Patients who have severe liver dysfunction or biliary atresia
- •Patients who are being treated with cyclosporine
- •Pregnant women, women suspected of being pregnant, or lactating women
- •Patients who have heart failure NYHA III or greater
- •Patients undergoing dialysis
- •Patients with familial hypercholesterolemia
- •Patients registered in the other clinical trials
- •Patients taking prohibited drugs
- •Patients who are ineligible in the opinion of the investigator
- •Exclusion Criteria(Post-Run-in period)
- •LDL-C is 120mg/dL or over after Run-in period
- •Patients with occurrence of acute coronary syndrome (AMI or Unstable angina) within 3 months
- •Patients who have been undergone PCI or CABG within 3 months
- •Compliance is less than 50% in Run-in period
- •Patients who met primary endpoint in Run-in period.
- •Patients who met adverse events in Run-in period and judged as ineligible in the opinion of the investigator
- •Patients who are ineligible in the opinion of the investigator
研究组 & 干预措施
Pitavastatin 1 mg daily
干预措施: Pitavastatin 1 mg daily or 4 mg daily (Drug)
Pitavastatin 4 mg daily
干预措施: Pitavastatin 1 mg daily or 4 mg daily (Drug)
结局指标
主要结局
Occurrence of one of following events(Cardiovascular death, Non-fatal Myocardial Infarction (MI), Non-fatal Cerebral Infarction (CI), Unstable angina requiring urgent hospitalization)
时间窗: 3-6 years
次要结局
- Composite cerebrovascular events(3-6 years)
- Cerebrovascular events(3-6 years)
- Composite cardiovascular events(3-6 years)
- Composite coronary heart disease events(3-6 years)
- The other events(3-6 years)
- Death events(3-6 years)
- Heart disease events(3-6 years)