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

NCT ID: NCT01870804

Last Updated: 2016-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 760 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-09-30

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.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type: DRUG

Atorvastatin

atorvastatin (80 mg on-admission followed by 40 mg/day before and after discharge)

Group Type: ACTIVE_COMPARATOR

Atorvastatin

Intervention Type: DRUG

Interventions

Rosuvastatin

Intervention Type: DRUG

Atorvastatin

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Cardiopatici Toscani

OTHER

Sponsor Role: lead

Responsible Party

Anna Toso

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Toso, MD

Role: PRINCIPAL_INVESTIGATOR

Prato Hospital, Italy

Locations

Cardiology Division, Prato Hospital

Prato, Prato, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 32434204 (View on PubMed)

Other Identifiers

472013

Identifier Type: -

Identifier Source: org_study_id