Atorvastatin Versus Rosuvastatin on Contrast Induced Acute Kidney Injury (PRATO-ACS 2)
- Registration Number
- NCT01870804
- Lead Sponsor
- Centro Cardiopatici Toscani
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 760
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rosuvastatin Rosuvastatin 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) Atorvastatin Atorvastatin atorvastatin (80 mg on-admission followed by 40 mg/day before and after discharge)
- Primary Outcome Measures
Name Time Method Contrast Induced-Acute Kidney Injury 72 hours Increase in serum creatinine ≥ 0.5 mg/dl or ≥ 25 % within 72 hours of contrast medium exposure
- Secondary Outcome Measures
Name Time Method Renal function at 30 days 30 days after discharge Estimation of the glomerular filtration rate in all patients at 30 days
Cardiovascular and renal outcome 30 days, 6 months, 12 months Composite cardiovascular and renal events at follow-up including acute renal failure requiring dialysis, persistent renal damage, all-causes mortality, myocardial infarction or stroke.
Myocardial Damage During hospitalization (average 5 days) Total cardiac biomarkers release during the index event
Anti-inflammatory effect of rosuvastatin and atorvastatin On admission (baseline), at discharge (after 5 days) & at 30 days High-sensitivity C-reactive protein (hs-CRP)will be measured on admission, at discharge and at 30 days.
Lipid-modulatory effects of atorvastatin and rosuvastatin On admission (baseline), at discharge (after 5 days) & at 30 days Low density lipoprotein (LDL) levels will be determined on admission, at discharge and at 30 days.
Trial Locations
- Locations (1)
Cardiology Division, Prato Hospital
🇮🇹Prato, Italy