To Investigate the Role of Upstream High Dose Statin in STEMI

Study Overview
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Brief Summary
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This is a double-blinded randomized placebo controlled trial investigating the role of upstream 80mg Atorvastastin-calcium in patients undergoing percutaneous intervention for acute STEMI.

Official Title
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A Double Blinded Randomized Placebo Controlled Study: To Investigate the Role of Upstream High Dose Statin Treatment in Patients With ST Segment Elevation Myocardial Infarction

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Drug: Atorvastatin calcium
* Drug: Inactive Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient of 25 to 90 years of age admitted or transferred to Western Pennsylvania Hospital or Allegheny General Hospital with a diagnosis of STEMI undergoing emergent percutaneous intervention (PCI) to the culprit coronary artery. STEMI is defined as greater than 1mm ST segment elevation on electrocardiogram. Elevated cardiac biomarkers (troponin-T > 0.03ng/ml, CKMB>5ng/mL, or ck>170 U/l). Exclusion Criteria: Known history of liver disease defined as cirrhosis, alcoholic liver disease, Non alcoholic steatohepatitis, hepatitis or any causes of liver failure. Renal failure with creatinine >3mg/dL Known history of liver or muscle disease such as rheumatologic myopathies, history of myositis, hepatitis, and hepatic cancer. Cardiovascular arrest and shock.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 90 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atorvastatin calcium<br>Patients will receive study medication upon admission to hospital prior to percutaneous intervention of the culprit artery | Drug: Atorvastatin calcium<br>* Eligible patients will receive 80mgs of atorvastatin orally upon admission to hospital prior to percutaneous intervention of the affected artery. Dose of post-procedural statin will be at the discretion of the cardiologist.<br>* Other names: Lipitor;|
| Placebo Comparator: Sugar Pill<br>Patients will receive study medication upon admission to hospital prior to percutaneous intervention of the culprit artery | Drug: Inactive Placebo<br>* Eligible patients will receive a placebo orally upon admission to hospital prior to percutaneous intervention of the affected artery.<br>* Other names: Placebo, Sugar Pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular event (MACE) defined as cardiovascular death, MI, or target revascularization 30 days post percutaneous intervention. |  | 15 and 30 days post revascularization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any increase in mean peak values of CK-MB, troponin I and myoglobin greater than twice the upper limit after intervention. |  | 15 and 30 days post revascularization | 
| Any occurrence of major adverse cardiac events defined as death, MI, congestive heart failure, cardiogenic shock or need for unplanned revascularization within 24 hours after procedure or need for emergent CABG. |  | 15 and 30 days post revascularization | 
| Symptomatic side effects of current statin medication as described by adverse effects on consent form. |  | Immediately post revascularization to 30 days. | 
| Modified Coronary Revascularization Outcome Questionnaire (CROQ-PTCA) |  | 15 and 30 days post revascularization |