Clinical trial NCT01334671: The Clinical Effect of Intensive Statin Therapy in STEMI Patients Before Emergency PCI
Official title: The Clinical Effect of Intensive Statin Therapy in STEMI(ST-elevated Myocardial Infarction) Patients Before Emergency PCI(Percutaneous Coronary Intervention)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: ST-elevation Myocardial Infarction
(STEMI)
Keywords: ST-elevation myocardial infarction(STEMI)
emergency percutaneous coronary intervention(PCI)
lipitor or Atorvastatin
Lead sponsor: General Hospital of Chinese Armed Police Forces
Sponsor class: OTHER
First posted: 2011-04-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 1.Clinical diagnosis of STEMI less than 12 hours 2.Eligible for emergency PCI

Exclusion Criteria:

* 1.Contradiction to atorvastatin 2.Contradiction to aspirin, clopidogrel and contrast medium 3.Life expectancy less than 3 months 4.Tumor or inflammatory diseases

Primary outcomes:
measure: MACEs (Major adverse cardiac events)
timeFrame: follow-up for 6 months
Secondary outcomes:
measure: Echocardiographic changes
timeFrame: postoperative 6 month
measure: HS-CRP,NO,SAA values
timeFrame: preoperation 1 hour,postoperative 24 and 72 hours,postoperative 7 days
measure: CK,CK-MB
timeFrame: preoperation 1hour,postoperation 4/8/12/16/20/24hours
measure: AST(glutamic-oxalacetic transaminease ),ALT(glutamic-pyruvic transaminase),LDL(low density lipoprotein cholesterin),TG(triglyceride)
timeFrame: preoperation 1 hour,postoperation 24 and 72hours,postoperation 7 days
Other outcomes:
Locations:
city: BeiJing
country: China
facility: General Hospital of Chinese People's Armed Police Forces
Study officials:
affiliation: Department of Cardiology of General Hospital of Chinese People's Armed Police Forces
name: HuiLiang Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
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