Ignite Creation Date:
2024-05-06 @ 1:43 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01870804
Status:
COMPLETED
Last Update Posted:
2016-10-06
First Post:
2013-05-30
Brief Title:
Atorvastatin Versus Rosuvastatin on Contrast Induced Acute Kidney Injury PRATO-ACS 2
Sponsor:
Centro Cardiopatici Toscani
Organization:
Centro Cardiopatici Toscani
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRATO-ACS-2
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 mgday 2 high-dose atorvastatin 80 mg on-admission followed by 40 mgday 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 05 mgdl 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
Patients are randomized into two groups 1 high-dose rosuvastatin 40 mg on-admission followed by 20 mgday 2 high-dose atorvastatin 80 mg on-admission followed by 40 mgday 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 05 mgdl 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None