The Clinical Effect of Intensive Statin Therapy in STEMI Patients Before Emergency PCI
- Registration Number
- NCT01334671
- Lead Sponsor
- General Hospital of Chinese Armed Police Forces
- Brief Summary
The purpose of this study is to evaluate the clinical effect of intensive statin therapy before emergency PCI in patients with STEMI.
- Detailed Description
150 STEMI patients planned for emergency PCI were randomized to three groups, Group 1:received atorvastatin 80-mg loading dose before PCI then followed by 40-mg daily for one month and a maintenance dose of 20-mg qd thereafter(n=50); Group 2:received atorvastatin 40-mg qd after PCI for one month and a maintenance dose of 20-mg qd thereafter(n=50); Group 3: received atorvastatin 20-mg qd after PCI (n=50).Before PCI,all subjects received oral administration of aspirin 300mg and clopidogrel 300mg.Levels of creatine kinase,CK-MB(creatine kinase-MB),were measured to estimate myocardial damage degree.HS-CRP(high sensitivity C -reactive protein),NO(NO synthase),SAA(Serum amyloid A) were measured at preoperation 1 hour,postoperative 24 and 72 hours,7days after PCI. To compare echocardiography changes among three groups.Patients enrolled in the study need to receive follow-up survey which was carried out by clinical doctors.Hence,MACEs were analyzed during 6-month follow-up.So, the aim of our study is to evaluate the clinical significance of loading dosage of atorvastatin therapy and analyze the mechanism underlying it.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- 1.Clinical diagnosis of STEMI less than 12 hours 2.Eligible for emergency PCI
- 1.Contradiction to atorvastatin 2.Contradiction to aspirin, clopidogrel and contrast medium 3.Life expectancy less than 3 months 4.Tumor or inflammatory diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group 1, Atorvastatin Atorvastatin STEMI patients will be randomly divided into three groups Group 1 which has been give 80mg atorvastatin before PCI will be administered with atorvastatin 40mg per day for one month,then 20mg per day until the end of the trial group 2 , Atorvastatin Atorvastatin Group 2 will be administered with atorvastatin 40mg per day for one month,then 20mg per day until the end of the trial group 3 , Atorvastatin Atorvastatin Group 3 will be administered with atorvastatin 20mg per day until the end of the trial
- Primary Outcome Measures
Name Time Method MACEs (Major adverse cardiac events) follow-up for 6 months MACEs were compared among three groups during follow-up in STEMI patients undergoing emergency PCI.
- Secondary Outcome Measures
Name Time Method Echocardiographic changes postoperative 6 month to compare echocardiographic changes ( left ventricular ejection fraction(LVEF); Left Ventricular Internal Diameter diastolic(LVIDd);Left Ventricular Internal Diameter systolic (LVIDs),Left Ventricular Enddiastolic Volume(LVEDV);Left Ventricular Endsystolic Volume(LVESV)at postoperative 6 month among three groups
HS-CRP,NO,SAA values preoperation 1 hour,postoperative 24 and 72 hours,postoperative 7 days to compare hs-crp,no,saa values at differnt treatment period among three groups
CK,CK-MB preoperation 1hour,postoperation 4/8/12/16/20/24hours to estimate myocardial damage degree among three groups
AST(glutamic-oxalacetic transaminease ),ALT(glutamic-pyruvic transaminase),LDL(low density lipoprotein cholesterin),TG(triglyceride) preoperation 1 hour,postoperation 24 and 72hours,postoperation 7 days to monitor adverse drug reaction
Trial Locations
- Locations (1)
General Hospital of Chinese People's Armed Police Forces
🇨🇳BeiJing, China