Effect of Atorvastatin Versus Rosuvastatin Intensive Statin Regimens on Chinese Elderly Patients Undergoing Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- 30-day MACCEs after PCI
研究概览
简要总结
This randomized, open label, parallel-group study is designed to investigate whether periprocedural intensive statin therapy with atorvastatin versus rosuvastatin administration before PCI and 30-day continuous intensive treatment is superior to usual care, in terms of cardiovascular events for Chinese elderly patients.
详细描述
1800 elderly patients (>65 yr) with coronary artery disease undergoing elective PCI were randomized in 2:1 fashion into either intensive statin group or standard care group. Patients in intensive statin group is further randomized into two subgroups: administrated with either atorvastatin 80mg 12h prior PCI, then 40mg 2h prior PCI, followed by 40 mg/d for 30 days after PCI; or rosuvastatin 20mg 12h prior PCI, then 10mg 2h prior PCI; followed by 10 mg/d for 30 days after PCI, while the standard care group receives atorvastatin 20 mg/d. After angiography, patients who are not undergoing PCI procedure will be excluded from the study as selection failure. The last visit will be at 6 months after PCI. Clinical data such as troponin, CK-MB, Scr, CCR, ALT, AST before and 24h to 48h after procedure will be recorded. 1000 eligible patients will be finally enrolled.The study will be conducted at 12 centers in China.
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
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65-80 years old Patients undergoing for elective percutaneous coronary intervention Evidence of a personally signed and dated informed consent document
排除标准
- •Patients undergoing emergency percutaneous coronary intervention
- •Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin (such as simvastatin 20mg/d, pruvastatin 40mg/d, fluvastatin 80mg/d or rovastatin 5mg/d ) in the next 6 months, or needing to take fibrates or niacins simultaneously according to investigators' judgment.
- •LDL-C < 1.8mmol/L in patients without statin therapy
- •Endstage congestive heart failure, or LVEF < 30%
- •Active hepatic disease or hepatic dysfunction, or AST/ALT > 1.5UNL
- •Myopathy or increased creatine kinase (CK>2 UNL)
- •WBC < 4×109/L or PLT < 100×109/L
- •Severe renal dysfunction(Scr > 3 mg/dl or 264μmol/L)
- •Allergic or experienced serious adverse reaction to HMG-CoA reductase, or ineligible to take statin as investigator's judgment
- •Severe aortic valve stenosis or severe mitral stenosis, Obstructive hypertrophic cardiomyopathy, pericardial diseases
- •Accompanied with malignant disease or other disease, which cause life expectancy < 6 months
- •Participating in other interventional clinical trials using drugs or devices
- •Patients with any condition which, in the investigator's judgment, might increase the risk to the subject for any adverse event or abnormal laboratory finding
研究组 & 干预措施
standard care group
patients receive atorvastatin 20 mg/d
干预措施: Atorvastatin (Drug)
intensive rosuvastatin
administrated with rosuvastatin 20mg 12h prior PCI, then 10mg 2h prior PCI; followed by 10 mg/d for 30 days after PCI
干预措施: Rosuvastatin (Drug)
intensive atorvastatin
patients will be administrated with atorvastatin 80mg 12h prior PCI, then 40mg 2h prior PCI, followed by 40 mg/d for 30 days after PCI;
干预措施: Atorvastatin (Drug)
结局指标
主要结局
30-day MACCEs after PCI
时间窗: 30-day after PCI
30-day major adverse cardio- and cerebralvascular events (combined endpoints of cardiac death, myocardial infarction, stroke, stent thrombosis and target vessel revascularization ) after PCI
次要结局
- changes in myocardial biomarkers (troponin I, Creatine kinase-MB)(24 hours after PCI)
研究者
Yujie Zhou
Vice President of Anzhen Hospital
Beijing Anzhen Hospital