Effect of Atorvastatin Versus Rosuvastatin Intensive Statin Regimens on Chinese Elderly Patients Undergoing PCI
- Registration Number
- NCT01646307
- Lead Sponsor
- Beijing Anzhen Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
65-80 years old Patients undergoing for elective percutaneous coronary intervention Evidence of a personally signed and dated informed consent document
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description standard care group Atorvastatin patients receive atorvastatin 20 mg/d intensive rosuvastatin Rosuvastatin administrated with rosuvastatin 20mg 12h prior PCI, then 10mg 2h prior PCI; followed by 10 mg/d for 30 days after PCI intensive atorvastatin 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;
- Primary Outcome Measures
Name Time Method 30-day MACCEs after PCI 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
- Secondary Outcome Measures
Name Time Method changes in myocardial biomarkers (troponin I, Creatine kinase-MB) 24 hours after PCI changes in myocardial biomarkers (troponin I, Creatine kinase-MB)
Trial Locations
- Locations (1)
Beijing Anzhen Hospital
🇨🇳Beijing, China