Statin Contrast Induced Nephropathy Prevention

Phase 4

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Rosuvastatin

• Registration Number: NCT01185938
• Lead Sponsor: Centro Cardiopatici Toscani

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 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 Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-03
• Study First Submitted QC: 2010-08-19
• Study First Posted: 2010-08-20
• Primary Completion: 2012-09
• Status Verified: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2012-10-18
• Last Update Posted: 2012-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin	Rosuvastatin	-

Primary Outcome Measures

Name	Time	Method
Incidence of contrast-induced nephropathy in patients with Acute Coronary Syndrome treated with rosuvastatin versus control	3 days

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cardiology Division, Prato Hospital; 🇮🇹 Prato, Italy