Statin Contrast Induced Nephropathy Prevention

Acute Coronary Syndrome Clinical Trial

— PRATO-ACS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185938
• Other study ID #: 552010
• Status: Completed
• Phase: Phase 4
• First received: August 3, 2010
• Last updated: October 18, 2012
• Start date: July 2010
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Centro Cardiopatici Toscani
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Interventional

Clinical Trial 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

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 and/or angioplasty, may exert a renal-protective effect by reducing the incidence of contrast nephropathy. Contrast induced nephropathy is defined as increased values of creatinine >= 0.3 mg/dl from baseline values, within 72 hours after contrast medium exposure.

Secondary end points: 1) verify if short-term (<48 hours)statin 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

Are eligible for the study all patients admitted to CCU for Acute Coronary Syndrome without ST elevation (NSTEMI) candidates for early invasive strategy (coronary angiography within 48 hours from the admission) and without previous therapy with statins.

Exclusion Criteria:

1. inability to provide consent

2. pregnancy or lactation

3. intolerance to statins

4. therapy with other lipid lowering drugs

5. acute or chronic liver disease

6. chronic muscle disease

7. acute renal failure or chronic renal failure stage IV

8. neoplastic

9. exposure to iodinated contrast medium in the previous 10 days

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Drug:
• Rosuvastatin
One oral single dose of rosuvastatin of 40 mg at admission and then 20 mg/day for 1 month.

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	Incidence of contrast-induced nephropathy in patients with Acute Coronary Syndrome treated with rosuvastatin versus control		3 days	Yes
Secondary	Peak levels and curve areas of myocardial necrosis markers measured throughout the hospitalization period.	Quantitative creatine kinase-MB (CK-MB) mass and cTn I were 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 angioplasty, biochemical markers were measured at 12 and 24 hours after procedure.	5 days (average)	Yes
Secondary	Distribution of peripheral lymphocyte populations at the entry and at discharge	Comparison between groups for the distribution of peripheral lymphocyte sub-population evaluated bu Flow Cytometric Analysis at the admission and at discharge.	5 days (average)	No
Secondary	Incidence of clinical composite outcome (death, myocardial infarction, urgent revascularization, dialysis and stroke).	Clinical follow-up at 30 days and 6 month after the hospitalization for the Acute Coronary Syndrome.	30 days and 6 months	Yes