Atorvastatin Versus Rosuvastatin on Contrast Induced Acute Kidney Injury (PRATO-ACS 2)

Study Overview
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Brief Summary
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The aim of the project is to compare the nephro-protective effects of high-dose atorvastatin and high-dose rosuvastatin on the incidence of Contrast Induced-Acute Kidney Injury in patients with non-ST-elevation acute coronary syndromes scheduled for early invasive strategy.

Detailed Description
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This is a prospective, single-centre, randomized study, designed to compare the nephro-protective effects of high-dose atorvastatin and high-dose rosuvastatin on the incidence of Contrast Induced-Acute Kidney Injury (CI-AKI). Consecutive statin-naïve patients admitted in the investigators institution for non-ST elevation Acute Coronary Syndrome (NSTE-ACS) and scheduled for early invasive strategy will be eligible. Patients are randomized into two groups: 1) high-dose rosuvastatin (40 mg on-admission followed by 20 mg/day); 2) high-dose atorvastatin (80 mg on-admission followed by 40 mg/day). Randomization will be performed on-admission by computerized open-label assignment in blinded envelopes used in a consecutive fashion. All patients receive the standard pre-procedural hydration. The primary end-point is the proportion of patients with an increase in serum creatinine of ≥ 0.5 mg/dl or ≥ 25% above baseline within 72 hours after contrast medium administration. The secondary end-points are persistent worsening of renal damage (eGFR reduction >= 25% at 30 days) and cumulative adverse clinical events at follow-up. Specifically: death, myocardial infarction, dialysis, stroke or persistent renal damage at 30 days; death or myocardial infarction at 6 and 12 months.

Official Title
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Impact of Early High-dose Atorvastatin Versus Rosuvastatin on Contrast Induced Acute Kidney Injury in Unselected Patients With Non- ST Elevation Acute Coronary Syndromes Scheduled for Early Invasive Strategy.

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All consecutive statin-naive patients with non ST-elevation acute coronary syndrome admitted to our institution and scheduled for early invasive strategy are considered for enrollment Exclusion Criteria: Current statin treatment High-risk features warranting emergency coronary angiography (within 2 hours) Acute renal failure or end-stage renal failure requiring dialysis or serum creatinine ≥ 3 mg/dl Severe comorbidities which precluded early invasive strategy Contraindications to statin treatment Contrast media administration within the last 10 days Pregnancy Refusal of consent

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rosuvastatin<br>Rosuvastatin (40 mg on-admission followed by 20 mg/day) until discharge; then 20 mg/day (10 mg/day if creatinine clearance < 30 ml/min) | Drug: Rosuvastatin<br> <br> |
| Active Comparator: Atorvastatin<br>atorvastatin (80 mg on-admission followed by 40 mg/day before and after discharge) | Drug: Atorvastatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast Induced-Acute Kidney Injury | Increase in serum creatinine ≥ 0.5 mg/dl or ≥ 25 % within 72 hours of contrast medium exposure | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function at 30 days | Estimation of the glomerular filtration rate in all patients at 30 days | 30 days after discharge | 
| Cardiovascular and renal outcome | Composite cardiovascular and renal events at follow-up including acute renal failure requiring dialysis, persistent renal damage, all-causes mortality, myocardial infarction or stroke. | 30 days, 6 months, 12 months | 
| Anti-inflammatory effect of rosuvastatin and atorvastatin | High-sensitivity C-reactive protein (hs-CRP)will be measured on admission, at discharge and at 30 days. | On admission (baseline), at discharge (after 5 days) & at 30 days | 
| Lipid-modulatory effects of atorvastatin and rosuvastatin | Low density lipoprotein (LDL) levels will be determined on admission, at discharge and at 30 days. | On admission (baseline), at discharge (after 5 days) & at 30 days | 
| Myocardial Damage | Total cardiac biomarkers release during the index event | During hospitalization (average 5 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Statins, Contrast-Induced Acute Kidney Injury, Periprocedural Myocardial Damage