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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
760
Cardiology Division, Prato Hospital
Prato, Prato, Italy
Contrast Induced-Acute Kidney Injury
Increase in serum creatinine ≥ 0.5 mg/dl or ≥ 25 % within 72 hours of contrast medium exposure
Time frame: 72 hours
Renal function at 30 days
Estimation of the glomerular filtration rate in all patients at 30 days
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: On admission (baseline), at discharge (after 5 days) & at 30 days
Myocardial Damage
Total cardiac biomarkers release during the index event
Time frame: During hospitalization (average 5 days)
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