Effect of Atorvastatin and Lifestyle Intervention on Progression of Carotid Intima-Media Thickness in Chinese People Without Manifest Atherosclerotic Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- The progress of CIMT
研究概览
简要总结
The purpose of this study is to determine whether atorvastatin, aggressive lifestyle intervention, and their interaction are effective in delaying the progress of pre-clinical atherosclerosis.
详细描述
Primary prevention of atherosclerotic disease remains a big challenge. Currently, it is not clear how to treat those subjects with evidence of pre-clinical atherosclerosis but without obvious conventional risk factors. This randomized, placebo controlled, double blind study is to evaluate the effect of Atorvastatin 10 mg daily, therapeutic lifestyle change, and their combination, on the progression of CIMT in those with higher baseline CIMT value but are not belong to 'high risk' category, according to the conventional risk factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CIMT is not less than 0.9 mm
- •without Clinical diagnosis of atherosclerotic disease
- •without Diabetes
排除标准
- 未提供
研究组 & 干预措施
D+N
Atorvastatin 10mg/d
干预措施: Atorvastatin (Drug)
P+A
lifestyle intervention without Atorvastatin
干预措施: Aggressive lifestyle intervention (Behavioral)
D+A
lifestyle intervention and Atorvastatin 10mg/d
干预措施: Atorvastatin (Drug)
D+A
lifestyle intervention and Atorvastatin 10mg/d
干预措施: Aggressive lifestyle intervention (Behavioral)
结局指标
主要结局
The progress of CIMT
时间窗: 2 years
次要结局
- The progress of ABI(2 years)
- The progress of PWV(2 years)
- Occurrence of atherosclerotic disease(2 years)