Clinical trial NCT01870804: Atorvastatin Versus Rosuvastatin on Contrast Induced Acute Kidney Injury (PRATO-ACS 2)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Keywords: Statins
Contrast-Induced Acute Kidney Injury
Periprocedural Myocardial Damage
Lead sponsor: Centro Cardiopatici Toscani
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 760
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Contrast Induced-Acute Kidney Injury
timeFrame: 72 hours
Secondary outcomes:
measure: Renal function at 30 days
timeFrame: 30 days after discharge
measure: Cardiovascular and renal outcome
timeFrame: 30 days, 6 months, 12 months
measure: Anti-inflammatory effect of rosuvastatin and atorvastatin
timeFrame: On admission (baseline), at discharge (after 5 days) & at 30 days
measure: Lipid-modulatory effects of atorvastatin and rosuvastatin
timeFrame: On admission (baseline), at discharge (after 5 days) & at 30 days
measure: Myocardial Damage
timeFrame: During hospitalization (average 5 days)
Other outcomes:
Locations:
city: Prato
country: Italy
facility: Cardiology Division, Prato Hospital
Study officials:
affiliation: Prato Hospital, Italy
name: Anna Toso, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toso A, Leoncini M, Maioli M, Tropeano F, Villani S, Bellandi F. A Prospective, Randomized, Open-Label Trial of Atorvastatin versus Rosuvastatin in the Prevention of Contrast-Induced Acute Kidney Injury, Worsened Renal Function at 30 Days, and Clinical Events After Acute Coronary Angiography: the PRATO-ACS-2 Study. Cardiorenal Med. 2020;10(5):288-301. doi: 10.1159/000506857. Epub 2020 May 20.