A Phase 4 interventional study of Rosuvastatin and Atorvastatin in Acute Coronary Syndrome, sponsored by Centro Cardiopatici Toscani. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-06.
Sponsored by Centro Cardiopatici Toscani · Phase 4, Interventional, and Prevention
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.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's enrollment of 760 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Centro Cardiopatici Toscani is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
atorvastatin (80 mg on-admission followed by 40 mg/day before and after discharge)
Drug: Atorvastatin
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)
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Centro Cardiopatici Toscani