Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing Percutaneous Coronary Intervention(PCI)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,884
- 试验地点
- 1
- 主要终点
- 30-day MACEs after PCI
研究概览
简要总结
This randomized, open label, controlled, parallel group study is designed to test whether 2-day high dose atorvastatin administration before PCI and 30-day continuous intensive atorvastatin treatment is superior to usual care, in terms of peri-PCI cardiovascular events, as well as 6-month prognosis. The goal is to set up an optimized protocol for peri-PCI statin treatment in Chinese CHD patients. Safety will also be observed.
详细描述
The study objective is to test whether 2-day high dose atorvastatin administration before PCI and 30-day continuous intensive atorvastatin treatment is superior to usual care, in terms of peri-PCI cardiovascular events, as well as 6-month prognosis.
2160 patients with non-ST segment elevated acute coronary syndrome (ACS)or stable angina pectoris (SAP) scheduled for selective PCI are randomized into two groups. The study group is given atorvastatin 80 mg/d×2d before PCI while the control group receives usual care. After angiography, patients who are not undergoing PCI procedure will be excluded from the study as selection failure. After PCI procedure, the study group is given atorvastatin 40mg/d until 30 days after PCI while the control group receive usual care. The last visit will be at 6 months after PCI. Patients data such as troponin, CK-MB, Scr, CCR, ALT, AST before and after procedure will be recorded. 1100 effective patients will be finally enrolled.
The study will be conducted at about 54 centers in China. Data will be collected on 2,100 NSTE or SAP patients undergoing PCI.
Primary outcome: MACE within 30 days after PCI. Secondary outcome: Post-procedural change of inflammatory biomarkers (hs-CRP); Morbidity of CIN; Proportion of patients who experience at least once AST > 3ULN，ALT > 3ULN or CK > 5ULN after initiation of study treatment. Proportion of patients who experience at least once AST, ALT, or CK>ULN after initiation of study treatment; Proportion of patients who take reduced dose of atorvastatin, withdraw study treatment, or withdraw study due to adverse events; Combined endpoint of death, cardiac death, myocardial infarction, heart failure, cardiac hospitalization, revascularization, and cerebrovascular events within 6 months after PCI.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20-75 years old
- •Patients with clinical diagnosis of NSTE-ACS (unstable angina or NSTE acute myocardial infarction) or stable angina pectoris (SAP) scheduled for selective coronary angiography
- •Evidence of a personally signed and dated informed consent document
排除标准
- •Patients presenting with ST-segment elevation acute myocardial infarction (STEMI) or high risk NSTE-ACS, warranting emergency coronary angiography:
- •Experienced STEMI within previous 30 days
- •Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin (such as simvastatin 20mg/d, pravastatin 40mg/d, fluvastatin 80mg/d or rosuvastatin 5mg/d ) in the next 6 months, or needing to take fibrates simultaneously according to investigators' judgment.
- •Anticipated repeated PCI within 6 months
- •LDL-C < 1.8mmol/L in patients without statin therapy in 1 months
- •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)
- •White blood cell < 4×109/L or platelet < 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
- •Pregnancy, lactation, or child bearing potential women without any effective contraception
- •Accompanied with malignant disease or other disease, which cause life expectancy < 6 months
- •Participating in other interventional clinical trails 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
Intensive statin therapy
Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care
干预措施: Atorvastatin (Drug)
Usual care
Usual care, but statin dose should not be higher than that described in exclusion criteria.
干预措施: Statin (Drug)
结局指标
主要结局
30-day MACEs after PCI
时间窗: 30 days after PCI
30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI
次要结局
- Post-procedural change of inflammatory biomarkers (hs-CRP)(24 hours after PCI)
- Morbidity of CIN(48 hours after PCI)
- Elevation of ALT, AST and CK(6 months after PCI)
- Adverse events(6 months after PCI)
- Combined endpoint of MACEs, cardiac hospitalization and cerebrovascular events(6 months after PCI)
研究者
Yong Huo
Director, Department of cardiology
Peking University First Hospital