Effect of Different Doses of Rosuvastatin Therapy on Regression of Critical Coronary Atherosclerosis in Chinese ACS Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percent Atheroma Volume (PAV)
研究概览
简要总结
The purpose of this study is to determine whether Rosuvastatin 10mg/d or 20mg/d for 36 weeks can regress critical coronary atherosclerosis as determined by IVUS imaging in Chinese Acute Coronary Syndrome (ACS) patients.
详细描述
This is a prospective, open-label, parallel group study to evaluate the efficacy of rosuvastatin 10mg/d or 20mg/d on critical coronary atherosclerosis in Chinese ACS patients. The anticipated duration of the study is approximately 36 weeks, Patients with angiographic luminal diameter narrowing in any non-culprit site between 40%-70% will be enrolled from the study site. The primary efficacy parameter is the percent change of Total Atheroma Volume (TAV) of critical coronary atherosclerosis after 36 weeks of treatment.
For inclusion in the study subjects should fulfill the following criteria:
- Provision of informed consent prior to any study specific procedures
- 18 to 75 years old ACS patients, male or female
- The angiographic luminal diameter narrowing in any non-culprit site is between 40%-70%
- statin-naive, defined as receiving no statin therapy within 3 monthsThe primary efficacy variable of the study is percent change of TAV from baseline after rosuvastatin 10mg/d or 20mg/d for 36 weeks as determined by IVUS imaging.
The secondary efficacy variables are:
- Change of blood lipid level from baseline at 12th, 24th, 36nd week
- Change of inflammatory markers from baseline at 36nd week
- Change of Percent Atheroma Volume (PAV) as determined by IVUS imaging at 36nd week
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •1.Provision of informed consent prior to any study specific procedures; 2.18 to 75 years old ACS patients, male or female; 3.The angiographic luminal diameter narrowing in any non-culprit site is between 40%-70%; 4.statin-naive, defined as receiving no statin therapy within 3 months;
排除标准
- •Have received statin therapy within 3 months;
- •The angiographic luminal diameter narrowing in any coronary vessels is more than 70%;
- •Active liver disease, ALT≥3*ULN;
- •Renal function damage, CrCl<30ml/min;
- •Pregnancy, lactation female;
- •Using cyclosporine;
- •Patients with uncontrolled triglyceride levels TG≥5.65 mmol／L;
- •Poorly controlled diabetes (HbA1c≥10%）Hypersensitivity to rosuvastatin or any of the recipients.
研究组 & 干预措施
Statins,lipid-lowering drugs
rosuvastatin 10mg or 20mg per day，pro
干预措施: rosuvastatin (Drug)
结局指标
主要结局
Percent Atheroma Volume (PAV)
时间窗: 36 weeks
Percent Atheroma Volume
次要结局
- inflammatory marker levels(36 weeks)
研究者
Hui Chen
Hui Chen,Director,Clinical Professor,Principal Investigator
Beijing Friendship Hospital