Intensive Statin Treatment for STEMI Patients Undergoing Primary PCI

Study Overview
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Brief Summary
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This is a retrospective, randomized, parallel, open-labeled, controlled study to find out whether STEMI patients undergoing emergency PCI can benefit from intensive atorvastatin treatment compared with routine treatment.

Detailed Description
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ARMYDA-ACS, ARMYDA-RECAPTURE and NAPLES II demonstrated that in patients with ASP and NSTE ACS undergoing early PCI, loading dose of atorvastatin before early PCI led to a reduction of prei-PCI MI, recurrent CV events and mortality. While, theses studies included patients with non-ST-segment elevation ACS, requiring PCI; these results cannot be extrapolated directly to patients with ST-segment elevation MI, and these trials included patients sent to an early and selective PCI, but not those undergoing emergency revascularization; This study is designed to find out whether STEMI patients undergoing emergency PCI can benefit from intensive atorvastatin treatment compared with routine treatment.

Official Title
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Effect of Intensive Statin Treatment on 90-day Prognosis of STEMI Patients Undergoing Emergency Primary PCI Compared With Usual Care

Conditions
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STEMI

Intervention / Treatment
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* Drug: atorvastatin
* Drug: atorvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20-75 years old myocardiac ischemia symptom of index event appeared less than 12 hours before enrollment. ECG showed elevated ST segment in 3 or more contiguous leads diagnosed with acute STEMI eligible for primary PCI, and primary PCI is scheduled within 2 hours after enrollment Exclusion Criteria: allergic or experienced serious adverse reaction to HMG-CoA reductase pregnancy, lactation, or child bearing potential women without any effective contraception accompanied with malignant disease active hepatic disease or hepatic dysfunction

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: usual care<br> | Drug: atorvastatin<br>* No loading dose of statin after enrollment, emergency PCI, atorvastatin 20mg/d and other usual medication after PCI<br>* Other names: Lipitor;|
| Experimental: intensive statin treatment<br> | Drug: atorvastatin<br>* 80mg atorvastatin immediately after enrollment, emergency PCI,atorvastatin 40mg/d and other usual medication after PCI<br>* Other names: Lipitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The combined endpoint of 90-day all cause morality, cardiac death, recurrent MI, recurrent symptomatic myocardiac ischemia, target vessel revascularization |  | 2009 Dec- 2011 Mar | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, atorvastatin, PCI