Impact of Combined Ezetimibe and Atorvastatin Therapy on Coronary Thin-cap Fibroatheroma As Assessed by Optical Coherence Tomography
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- minimum fibrous cap thickness
研究概览
简要总结
After successful coronary angiography and OCT examination, patients with TCFAs in non-culprit, mild-to-moderate stenotic lesions will be enrolled. Then, they will be randomly assigned in a 1:1 ratio to receive either atorvastatin (20 mg/day) alone or atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）by envelope method. Angiographic and OCT follow-up will be scheduled for the target vessel after 12 months.
详细描述
This is a prospective, randomized , controlled, open-label, single-center study to evaluate the effect of ezetimibe added to atorvastatin on coronary thin-cap fibroatheroma(TCFA). After successful coronary angiography and OCT examination, patients with TCFAs in non-culprit, mild-to-moderate stenotic lesions will be enrolled. Then, they will be randomly assigned in a 1:1 ratio to receive either atorvastatin (20 mg/day) alone or atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）by envelope method.
Angiographic and OCT follow-up will be scheduled for the target vessel after 12 months.The primary efficacy endpoint is the change in minimum fibrous cap thickness measured by OCT from baseline to follow-up.The secondary endpoints include absolute and percent changes in the lipid, glycemic, and inflammatory profile. Then, changes of these indicators above will be compared respectively in diabetic and non-diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.stable angina or acute coronary syndrome 2.18-80 years old 3.hypercholesterolemia :total cholesterol level >220 mg/dl (5.7mmol/L) and/or LDL-C level >140 mg/dl(3.6mmol/L), or previously receiving statins therapy
- •the target vessel for OCT interrogation has not undergone angioplasty and has angiographic diameter stenosis from 25% to 75% 5.There are TCFAs in non-culprit, mild-to-moderate stenotic lesions above
排除标准
- •administration of lipid-lowering drugs other than statins before enrollment
- •significant stenotic lesions in all coronary vessels
- •severe congestive heart failure (New York Heart Association class IV) ,or left ventricular ejection fraction<35%
- •more than 3 times of the upper limit of normal (ULN) in the creatine kinase (CK) and the transaminase level before enrollment and no relation with myocardial infarction
- •renal failure (serum creatinine>2.0 mg/dL）
- •hypersensitivity to x-ray contrast media, statin，clopidogrel or ezetimibe
- •Others: terminal stage cancer,a positive pregnancy test
研究组 & 干预措施
Ezetimibe and Atorvastatin Therapy
Atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）
干预措施: Ezetimibe and Atorvastatin (Drug)
Atorvastatin Therapy
Atorvastatin (20 mg/day）
干预措施: Atorvastatin (Drug)
结局指标
主要结局
minimum fibrous cap thickness
时间窗: 12months
The primary efficacy endpoint is the change in minimum fibrous cap thickness measured by OCT from baseline to follow-up.
次要结局
未报告次要终点
研究者
sunddong
Attending
Xijing Hospital