Statins Evaluation in Coronary Procedures and Revascularization Trial

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a loading dose of atorvastatin before percutaneous intervention procedures in acute coronary syndromes is effective to reduce major cardiovascular events(MACE).

Detailed Description
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Background: Strategies to reduce complications in acute coronary syndrome treatment have been largely studied. Due to its pleiotropic effects statins are considered an important tool on atherosclerotic plaque stability. Although, the usage of statins before percutaneous coronary intervention in acute coronary syndrome patients, has not yet been demonstrated. Objectives: Evaluate if a loading dose of atorvastatin (80mg) before percutaneous coronary intervention in acute coronary syndrome patients, followed by a reload dose 24 hours, is able to reduce major cardiovascular events (MACE); including combined outcomes such as all-cause mortality, nonfatal acute myocardial infarction, stroke or revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting after 30 days. Methods: Multicentric randomised controlled clinical trial, with allocation concealment and intention to treat analysis. Competitive recruitment will involve 4,192 patients. Acute coronary syndrome patients intending to undergo percutaneous coronary intervention with or without stent placement will be randomized 1:1 to receive either atorvastatin 80mg or placebo before the coronary procedure and also a reload dosage after 24 hours from angioplasty. All patients will collect blood sample to determine CKMB levels pre and post procedure (6 to 12h and 18 to 24 hours). After 30 days, an in person interview will be performed and blood sample will be collected in order to dosage AST, ALT, CPK, and cholesterol levels. Telephonic interview will be done at 6 and 12 months to access occurrence of cardiovascular events.

Official Title
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A Randomized, Multicenter Clinical Trial to Assess the Effect of Atorvastatin in Patients With Acute Coronary Syndrome and Intended Percutaneous Coronary Intervention

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute coronary syndrome patients intending to undergo percutaneous coronary intervention. Exclusion Criteria: Younger than 18 years Presence of any contraindication to statin (Pregnant women, breast-feeding women or statin hypersensibility) Advanced hepatic disease Use of statins at the maximum dosage in the last 24 hours before the loading dose of the study drug Use of fibrate in the last 24 hours

Ages Eligible for Study
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Minimum Age: 18 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<br> | Drug: Atorvastatin<br>* Atorvastatin loading dose of 80mg before PCI, reloading dose of 80mg 24 hours after PCI, and atorvastatin 40mg for 30 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matching placebo before PCI and 24 hours after PCI. Atorvastatin 40mg for 30 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Cardiovascular Events (MACE) | All-cause mortality, nonfatal acute myocardial infarction, stroke or revascularization with either percutaneous coronary intervention or coronary artery bypass grafting | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Cardiovascular Events (MACE) |  | 6 months and 12 months | 
| All-cause mortality |  | 30 days, 6 months and 12 months | 
| Non-fatal Myocardial Infarction |  | 30 days, 6 months and 12 months | 
| Non-fatal Stroke |  | 30 days, 6 months and 12 months | 
| Revascularization |  | 30 days, 6 months and 12 months | 
| Cardiovascular death |  | 30 days, 6 months and 12 months | 
| Stent Thrombosis |  | 30 days, 6 months and 12 months | 
| Target vessel revascularization |  | 30 days, 6 months and 12 months | 
| Rhabdomyolysis |  | 7 days or at hospital discharge | 
| Bleeding episode |  | 7 days or hospital discharge |