PRATO-ACS: Statin Contrast Induced Nephropathy Prevention

Sponsor

Centro Cardiopatici Toscani (Other)

Overall Status

Completed

CT.gov ID

NCT01185938

Collaborator

(none)

500

Enrollment

Location

Arms

Duration (Months)

18.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Drug: Rosuvastatin	Phase 4

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rosuvastatin	Drug: Rosuvastatin One oral single dose of rosuvastatin of 40 mg at admission and then 20 mg/day for 1 month.
No Intervention: Control

Arm

Intervention/Treatment

Active Comparator: Rosuvastatin

Drug: Rosuvastatin

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

No Intervention: Control

Outcome Measures

Primary Outcome Measures

Incidence of contrast-induced nephropathy in patients with Acute Coronary Syndrome treated with rosuvastatin versus control [3 days]

Secondary Outcome Measures

Peak levels and curve areas of myocardial necrosis markers measured throughout the hospitalization period. [5 days (average)]
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.
Distribution of peripheral lymphocyte populations at the entry and at discharge [5 days (average)]
Comparison between groups for the distribution of peripheral lymphocyte sub-population evaluated bu Flow Cytometric Analysis at the admission and at discharge.
Incidence of clinical composite outcome (death, myocardial infarction, urgent revascularization, dialysis and stroke). [30 days and 6 months]
Clinical follow-up at 30 days and 6 month after the hospitalization for the Acute Coronary Syndrome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.