Statin Contrast Induced Nephropathy Prevention

Centro Cardiopatici Toscani500 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

500

Conditions

Acute Coronary Syndrome

Interventions

RosuvastatinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Cardiology Division, Prato Hospital

Prato, Prato, Italy

Outcomes

Primary Outcomes

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

Time frame: 3 days

Secondary Outcomes

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.

Time frame: 5 days (average)

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.

Time frame: 5 days (average)

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.

Time frame: 30 days and 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.