Same Lipid Lowering by Atorvastatin Versus Atorvastatin Plus Ezetimibe on Coronary Plaque Progression
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- change of coronary artery plaque volume
研究概览
简要总结
Atherosclerosis is a progressive disease. Lipid lowering therapy was the standard treatment for patients with coronary artery disease. Studies indicated that coronary artery plaque progression had positive relationship with the plasma cholesterol level, and could be halted or reversed by intensive statin therapy (such as 20-40 mg/d atorvastatin). Ezetimibe plus statin could further lowered blood cholesterol level. Here the investigators hypothesize that same cholesterol lowering level by routing dose of atorvastatin or lower dose of atorvastatin plus ezetimibe could achieve the same effect on coronary artery plaque cessation or regression.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to receive the coronary angiography and potential PCI therapy
排除标准
- •Patients was treated by statins before randomization
- •Patient with ≤ 20% and ≥ 70% coronary narrowing and target lesion
- •ST elevation myocardial infarction less than 7 days
- •Without informed consent
- •Abnormal liver function before randomization, (AST, ALT ≥ULN)
- •Active hepatitis or muscular disease
- •Impaired renal function with serum creatinine level > 3mg/dl
- •Impaired left ventricular function with LVEF > 30%
- •Participate in other studies
研究组 & 干预措施
atorvastatin
patients will be treated with atorvastatin 10mg/d after randomization, and continued for two years
干预措施: atorvastatin (Drug)
atorvastatin and ezetimibe
patients will be treated with atorvastatin 5mg/d and Ezetimibe 5mg/d after randomization, and continued for two years
干预措施: atorvastatin plus ezetimibe (Drug)
结局指标
主要结局
change of coronary artery plaque volume
时间窗: 1 year
The primary endpoint was the change of coronary artery plaque volume measured by intravascular ultrasound (IVUS) at one year after randomization.
次要结局
- composite of adverse cardiac events(2 years)