Ignite Creation Date:
2024-05-05 @ 10:47 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01185938
Status:
COMPLETED
Last Update Posted:
2012-10-19
First Post:
2010-08-03
Brief Title:
Statin Contrast Induced Nephropathy Prevention
Sponsor:
Centro Cardiopatici Toscani
Organization:
Centro Cardiopatici Toscani
Study Overview
Official Title:
Protective Effect of Rosuvastatin and Antiplatelet Therapy On Contrast-induced Nephropathy and Myocardial Damage in Patients With Acute Coronary Syndrome Undergoing Coronary Intervention PRATO-ACS Trial
Status:
COMPLETED
Status Verified Date:
2012-10
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
Brief Summary:
This open-label study prospective randomized trial evaluating the acute in-hospital pleiotropic and clinical effects of a hydrophilic statin rosuvastatin in patients with acute coronary syndrome
Detailed Description:
The primary purpose of this study is to determine whether in patients with acute coronary syndromes not taking statins in chronic administration high doses of a hydrophilic statin rosuvastatin administered before coronary angiography andor angioplasty may exert a renal-protective effect by reducing the incidence of contrast nephropathy Contrast induced nephropathy is defined as increased values of creatinine 03 mgdl from baseline values within 72 hours after contrast medium exposure
Secondary end points 1 verify if short-term 48 hoursstatin administration reduces the peak levels and the curve areas of markers of myocardial necrosis throughout the hospitalization period and if reduces the occurrence of periprocedural infarction Biochemical markers quantitative creatine kinase-MB CK-MB mass and Troponin I are measured at admission and at 6 12 and 24 hours during the first day then once daily immediately before angiography and 24 hours thereafter In patients who underwent coronary angioplasty PCI biochemical markers were measured at 12 and 24 hours after the procedure Data were fitted peak values and curve areas calculated the occurrence of periprocedural infarction was defined as a CK-MB mass elevation more than three times the upper limit of normal within 24 hours after PCI 2 determine the distribution of peripheral lymphocytic populations at the entry and at discharge using the flow cytometric analysis 3 analyze the clinical composite outcome of death myocardial infarction urgent revascularization dialysis and stroke at 30 days and 6 months
Secondary end points 1 verify if short-term 48 hoursstatin administration reduces the peak levels and the curve areas of markers of myocardial necrosis throughout the hospitalization period and if reduces the occurrence of periprocedural infarction Biochemical markers quantitative creatine kinase-MB CK-MB mass and Troponin I are measured at admission and at 6 12 and 24 hours during the first day then once daily immediately before angiography and 24 hours thereafter In patients who underwent coronary angioplasty PCI biochemical markers were measured at 12 and 24 hours after the procedure Data were fitted peak values and curve areas calculated the occurrence of periprocedural infarction was defined as a CK-MB mass elevation more than three times the upper limit of normal within 24 hours after PCI 2 determine the distribution of peripheral lymphocytic populations at the entry and at discharge using the flow cytometric analysis 3 analyze the clinical composite outcome of death myocardial infarction urgent revascularization dialysis and stroke at 30 days and 6 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