Intravascular Ultrasound Evaluation of the Intervention Effect of Simvastatin Combined With Ezetimibe on Coronary Borderline Lesion in Patients With Stable Angina Pectoris and Diabetes Mellitus Compared With Simvastatin Alone
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Change from Baseline coronary plaque volume percentage(PAV) at 12 months
研究概览
简要总结
In this study, simvastatin combined with Ezeimebum was used to enhance lipid reduction, and IVUS was used to evaluate the volume and composition of coronary plaque before and after treatment. The aim is to evaluate the overall intervention effect of Ezeimebum on stable angina pectoris with diabetes mellitus on the basis of statins.
详细描述
This study was conducted in patients with stable angina pectoris complicated with diabetes mellitus in Chinese PLA General Hospital and coronary arteriography confirmed as critical lesion of coronary artery. The patients were randomly divided into two groups: ezeimebum combined with simvastatin group and simvastatin group. The patients of the former group were given ezeimebum 10mg combined with simvastatin 40mg for 12 months while the patients of the latter group were given simvastatin 40mg for 12 months. Assessed coronary atherosclerotic plaque volume percentage (PAV) and standardized total atherosclerotic plaque volume (TAV) by intravascular ultrasound (IVUS) at the time of entry and out of the group after 12 months. The changes of PAV level in both groups were taken as the main endpoints, and the changes of TAV levels in the two groups as the secondary endpoints. The changes of serum lipids and hypersensitive C-reactive protein levels were compared between the two groups before and after the treatment. Major cardiovascular events (non-fatal myocardial infarction, all-cause death, readmission to acute heart failure, and revascularization of recurrent angina pectoris) were followed up for 12 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 aged 18-75 years
- •consistent with the Chinese criteria for the diagnosis of chronic stable angina pectoris, stable angina pectoris symptoms in the last three months, and no more than CCS grade 3 of angina pectoris
- •coronary angiography showed that the degree of coronary artery stenosis was 50% and 70%
- •LDL-C standard: LDL-C > 80 mg/dL (2.08 mmol/L)
- •The patients diagnosed with type 2 diabetes were currently using hypoglycemic drugs or insulin
- •Sign the informed consent to join the group.
排除标准
- •Acute coronary syndromes such as myocardial infarction, unstable angina pectoris, variant angina pectoris, cardiac shock, chronic heart failure, malignant arrhythmia, etc.
- •Patients requiring stent implantation had been treated with intensive statins prior to admission (e.g. doses of Atto vastatin 40mg or resuvastatin 20mg)
- •There were contraindications or statins for statin lowering lipids or statins, and there was a history of adverse reactions (liver injury, rash, myolysis, etc.) in the use of Ezeimebum, etc.
- •Severe liver and kidney dysfunction, creatinine clearance < 30ml / min, acute pancreatitis, malignant tumor, etc.
研究组 & 干预措施
Ezetimibe with simvastatin group
ezetimibe 10mg with simvastatin 40mg everyday for 12 months after PCI
干预措施: Ezetimibe with simvastatin (Drug)
Simvastatin group
simvastatin 40mg everyday for 12 months after PCI
干预措施: Simvastatin (Drug)
结局指标
主要结局
Change from Baseline coronary plaque volume percentage(PAV) at 12 months
时间窗: 12 months after PCI
PAV=∑（(ESA CSA-lumen CSA)/(ESA CSA)）x100, EEM CSA：cross-sectional area of outer elastic membrane boundary; lumen CSA: cross-sectional area of tube boundary
次要结局
- TC(follow up in one year)
- LDL-C(follow up in one year)
- Change from Baseline standardized coronary plaque volume(TAV) at 12 months(12 months after PCI)
- HDL-C(follow up in one year)
- TG(follow up in one year)
- Inflammation marker(follow up in one year)
研究者
Qian geng
associate chief physician
Chinese PLA General Hospital