Comparison of High-dose Rosuvastatin Versus Low-dose Rosuvastatin Plus Ezetimibe on Carotid Plaque Inflammation in Patients With Acute Coronary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Percent change in most-diseased segment (MDS)-tissue blood ratio (TBR) of the index vessel
研究概览
简要总结
Combination therapy of ezetimibe with a low-dose statin is occasionally used to avoid statin-related side effects in clinical practice among patients with atherosclerotic cardiovascular disease. This approach is equivalent to high-dose statin therapy to decrease LDL cholesterol level by >50%, allowing such patients to achieve LDL cholesterol target. However, it remains uncertain whether combination therapy with ezetimibe and low-dose statin verse high-dose statin monotherapy similarily suppress atherosclerotic plaque inflammation. This study is to compare high-dose rosuvastatin versus low-dose rosuvastatin plus ezetimibe on carotid plaque inflammation in patients with acute coronary syndrome using 18F-fluorodeoxyglucose (18FDG) positron emission tomography (PET) imaging.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged ≥ 19 years
- •acute coronary syndrome, carotid artery disease (diameter stenosis 20-50%), and at least one 18FDG uptake lesion in the carotid artery (target to background ratio (TBR) ≥ 1.6) by 18FDG PET/CT imaging
- •written consent
排除标准
- •previous history of carotid endarterectomy or stenting
- •schedule for cardiac or major surgery within the next 6 months
- •statin or ezetimibe therapy in the past 4 weeks
- •chronic disease needed to be treated with oral, intravenous, or intraarticular steroid
- •end-stage renal disease
- •chronic liver disease
- •history of cancers within the past 3 years
- •pregnant, breast-feeding or child-bearing potential
- •expected life expectancy within 2 years
研究组 & 干预措施
Rosuvastatin
rosuvastatin 20 mg once a day for 6 months
干预措施: high-dose rosuvastatin (Drug)
ezetimibe/rosuvastatin
ezetimibe/rosuvastatin 10/5 mg once a day for 6 months
干预措施: low-dose rosuvastatin plus ezetimibe (Drug)
结局指标
主要结局
Percent change in most-diseased segment (MDS)-tissue blood ratio (TBR) of the index vessel
时间窗: 6 months
次要结局
- Change in high sensitive C-reactive protein(6 months)
- Change in total cholesterol(6 months)
- Change in whole vessel TBR within the index vessel(6 months)
- Change in LDL-cholesterol(6 months)
- Change in triglyceride(6 months)
- Change in HDL-cholesterol(6 months)
- Change in MDS TBR(6 months)
- Change in whole vessel TBR of the aorta(6 months)