An Open-label, Single-centre Randomized Study Evaluating the Effect of Treatment With Rosuvastatin 5/20mg on Atherosclerotic Disease as Measured by High-Resolution Contrast Enhanced Magnetic Resonance Imaging in Patients With Coronary Artery Disease and Hyperlipideimia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To evaluate whether 26 weeks of treatment with 5/20mg rosuvastatin results in regression of carotid atherosclerotic plaques as measured by CE-MRI
研究概览
简要总结
The aim of this study is to assess whether high intensive statin therapy could regress carotid atherosclerotic plaques as determined by High-Resolution Contrast Enhanced Magnetic Resonance imaging (CE-MRI).
Enrolled patients have a baseline CE-MRI examination for screening carotid atherosclerotic plaques and are randomized to either low dose of Rosuvastatin (5mg) group or high dose of Rosuvastatin (20mg) group. After 26 weeks, all patients received CE-MRI examination again and each pair of baseline and follow-up CE-MRI assessments was analyzed in a blinded fashion. Moreover, lipid level and major adverse cardiovascular events are also evaluated during 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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with coronary artery disease or carotid atherosclerotic plaque or hyperlipideimia or old myocardial infarction
排除标准
- •Planning coronary stenting
- •Heart failure
- •Uncontrolled hypertension（≥200/110mmHg)
- •Uncontrolled diabetes mellitus (HbA1C≥9.5%)
- •Hepatic insufficiency
- •Renal dysfunction
研究组 & 干预措施
low dose group (5mg)
low dose Rosuvastatin
干预措施: Rosuvastatin 5mg (Drug)
high dose group (20mg)
high dose Rosuvastatin
干预措施: Rosuvastatin 20mg (Drug)
结局指标
主要结局
To evaluate whether 26 weeks of treatment with 5/20mg rosuvastatin results in regression of carotid atherosclerotic plaques as measured by CE-MRI
时间窗: 26 weeks
次要结局
- To evaluate the change from baseline in creatine kinase at 26 weeks(26 weeks)
- major adverse cardiovascular events(26 weeks)
- To evaluate the change from baseline in liver function (AST/ALT) at 26 weeks(26 weeks)
- To evaluate the change in lipid and lipoprotein levels as assessed by percentage change from baseline.(26 weeks)
- To evaluate the change from baseline in renal function (serum creatine) at 26 weeks(26 weeks)
研究者
Buxing Chen
Director of department of cardiology
Capital Medical University