Protective Effect of Early High Dose stATins On Cardiovascular and Renal Events in Acute Coronary Syndrome

Study Overview
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Brief Summary
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Registration of all ACS patients (STEMI and NSTEMI) admitted to the cardiology ward and scheduled for early invasive strategy. The aim is to evaluate the protective effects of early (on admission) high-dose high-potency statin therapy on early and mid-term cardiac and renal events in this subset of patients.

Detailed Description
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Statin-naive patients and those on statin therapy with ACS who are admitted to the cardiology ward of our public (National Health Service) hospital and are scheduled for early invasive strategy receive immediately on admission, always before angiographic procedure, high-dose statin therapy. Either atorvastatin 80 mg or rosuvastatin 40 mg is administered at the discretion of the physician. During hospitalization various pertinent cardiac and renal parameters, including hematological, angiographic, clinical data are registered in a dedicated database. Clinical follow-up and hematological analysis are done 1 month after discharge. A second follow-up, either clinical or by telephone, is done 1 year after discharge.

Official Title
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The Protective Effect of Early High Dose High-intensity Statins on Cardiovascular and Renal Events in Patients With Acute Coronary Syndrome

Conditions
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Acute Coronary Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute coronary syndrome (ST elevation and non ST elevation) Early invasive strategy Exclusion Criteria: contraindication to statin therapy refusal of consent
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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute renal function changes | Changes in creatinine and/or cystatine values | Within 72 hours after hospital admission | 
| Inflammatory profile changes | Changes from baseline in CRP values | up to 1 month | 
| Lipid profile changes | Changes from baseline in cholesterol values | up to 1 month | 
| Platelet count | Changes from baseline in platelet count | up to 1 month | 
| Platelet volume | Changes from baseline in platelet volume | up to 1 month | 
| Platelet aggregation profile | Changes from baseline in platelet reactivity (Verify Now) | up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardiovascular adverse events | Death, myocardial infarction, stroke or coronary revascularization | up to 12 months | 
| Renal function changes | glomerular filtration rate | Changes from baseline at 1 month | 
| Major adverse cardiovascular and renal adverse events | Death, myocardial infarction, stroke, coronary revascularization or glomerular filtration rate reduction > = 25% compared to baseline | up to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, NSTEMI, Acute kidney injury, Renal function, Statin therapy