Efficacy of High Dose atorvaSTATIN Loading Before Primary Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction (STATIN STEMI)

Study Overview
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Brief Summary
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Although statin prior to PCI has favorable effects in stable angina and ACS except ST elevation MI (STEMI), there have been few studies for STEMI. Celik T et al. reported in patients with STEMI that prior statin use may improve coronary blood flow after PCI in patients with AMI, possibly by its beneficial effects on microvascular function. But this study was retrospective, non-randomized study and evaluated the effects for chronic statin therapy not acute high dose effect. Therefore, the investigators investigated whether acute high-dose statin prior to primary PCI in ST segment elevation myocardial infarction can have beneficial effect or not for periprocedural period and 30 days-cardiac events.

Official Title
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Efficacy of High Dose Atorvastatin Loading in ST Elevation Myocardial Infarction

Conditions
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Myocardial Infarction, Angioplasty, Percutaneous Coronary

Intervention / Treatment
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* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must be at least 18 years and 80 years of age. The patient had the symptoms of acute myocardial infarction within 12 hours with ST segment elevation of more than 1 mm in at least two contiguous leads of EKG or new onset LBBB. The patient or guardian agrees to the study protocol and provides informed, written consent. Exclusion Criteria: Patients to whom PCI can not be undergone within 12 hours from receiving the study drug Cardiogenic shock or symptomatic hypotension or sitting SBP < 95 mmHg The history of major surgery, trauma, retinal hemorrhage, significant gastrointestinal or genitourinary bleeding within recent 6 weeks; history of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit History of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit Severe or malignant hypertension (= sitting SBP > 180 mmHg and/or sitting DBP > 105 mmHg) The history or diagnosis of vasculitis; renal insufficiency (the level of serum creatinine is two times higher than the upper limit of normal of each center) The patients who might die of other disease than cardiac disease during the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: High dose Atorvastatin 80 mg<br>Administered Atorvastatin 80 mg before intervention | Drug: Atorvastatin<br>* Atorvastatin 10 mg vs. 80 mg before intervention<br>|
| Active Comparator: Control<br>Administered Atorvastatin 10 mg before intervention | Drug: Atorvastatin<br>* Atorvastatin 10 mg vs. 80 mg before intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of high dose atorvastatin in STEMI - 30 Days MACE(death, myocardial infarction, target vessel revascularization) |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of high dose atorvastatin in STEMI - TIMI flow at before and after PCI - Myocardial blush grade after PCI - Procedural success (No reflow incidence) - MACE at 6 month - Periprocedural MI |  | immediate, 30 days, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial Infarction, Coronary Angioplasty, Myocardial infarction, Angioplasty, Transluminal, Percutaneous Coronary