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

Acute Coronary Syndrome Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870804
• Other study ID #: 472013
• Status: Completed
• Phase: Phase 4
• First received: May 30, 2013
• Last updated: October 5, 2016
• Start date: May 2013
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Centro Cardiopatici Toscani
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 760
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Kidney Injury
• Syndrome

Intervention

Drug:
• Rosuvastatin

• Atorvastatin

Locations

Country	Name	City	State
Italy	Cardiology Division, Prato Hospital	Prato

Sponsors (1)

Lead Sponsor	Collaborator
Centro Cardiopatici Toscani

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast Induced-Acute Kidney Injury	Increase in serum creatinine = 0.5 mg/dl or = 25 % within 72 hours of contrast medium exposure	72 hours	Yes
Secondary	Renal function at 30 days	Estimation of the glomerular filtration rate in all patients at 30 days	30 days after discharge	No
Secondary	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.	30 days, 6 months, 12 months	Yes
Secondary	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.	On admission (baseline), at discharge (after 5 days) & at 30 days	No
Secondary	Lipid-modulatory effects of atorvastatin and rosuvastatin	Low density lipoprotein (LDL) levels will be determined on admission, at discharge and at 30 days.	On admission (baseline), at discharge (after 5 days) & at 30 days	No
Secondary	Myocardial Damage	Total cardiac biomarkers release during the index event	During hospitalization (average 5 days)	Yes