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

Centro Cardiopatici Toscani

Status and phase

Completed

Phase 4

Conditions

Acute Coronary Syndrome

Treatments

Drug: Atorvastatin

Drug: Rosuvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01870804

472013

Details and patient eligibility

About

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.

Full 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.

Enrollment

760 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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