The Clinical Effect of Intensive Statin Therapy in STEMI Patients Before Emergency PCI

General Hospital of Chinese Armed Police Forces

Status and phase: Unknown; Phase 3

Conditions: ST-elevation Myocardial Infarction; (STEMI)

Treatments: Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01334671

W2-2009041

Details and patient eligibility

About

The purpose of this study is to evaluate the clinical effect of intensive statin therapy before emergency PCI in patients with STEMI.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

group 1, Atorvastatin

Experimental group

Description:

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

Treatment:

Drug: Atorvastatin

group 2 , Atorvastatin

Experimental group

Description:

Group 2 will be administered with atorvastatin 40mg per day for one month,then 20mg per day until the end of the trial

Treatment:

Drug: Atorvastatin

group 3 , Atorvastatin

Experimental group

Description:

Group 3 will be administered with atorvastatin 20mg per day until the end of the trial

Treatment:

Drug: Atorvastatin