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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Incidence of contrast-induced nephropathy in patients with Acute Coronary Syndrome treated with rosuvastatin versus control
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •inability to provide consent
- •pregnancy or lactation
- •intolerance to statins
- •therapy with other lipid lowering drugs
- •acute or chronic liver disease
- •chronic muscle disease
- •acute renal failure or chronic renal failure stage IV
- •exposure to iodinated contrast medium in the previous 10 days
研究组 & 干预措施
Rosuvastatin
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Incidence of contrast-induced nephropathy in patients with Acute Coronary Syndrome treated with rosuvastatin versus control
时间窗: 3 days
次要结局
- Peak levels and curve areas of myocardial necrosis markers measured throughout the hospitalization period.(5 days (average))
- Distribution of peripheral lymphocyte populations at the entry and at discharge(5 days (average))
- Incidence of clinical composite outcome (death, myocardial infarction, urgent revascularization, dialysis and stroke).(30 days and 6 months)
研究者
Anna Toso
MD
Centro Cardiopatici Toscani
