A Randomized Trial of Rosuvastatin in Elective Percutaneous Coronary Intervention to Prevent Contrast-induced (CLEAR-CIN).
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 493
- 试验地点
- 1
- 主要终点
- Contrast induce nephropathy defined by serum creatinine increase more than 0.3mg/dl or 50% higher than baseline
研究概览
简要总结
The investigators analyzed the HMG-CoA reductase inhibitor, rosuvastatin, for the prevention of contrast-medium-induced nephropathy in patients undergoing primary angioplasty.
详细描述
Patients with stable coronary artery disease already taking chronic statin undergoing elective angioplasty are at risk for contrast-medium-induced nephropathy because there are specified risk factors as age more than 75 years, chronic renal insufficiency, diabetes, use of contrast and the lack of effective prophylaxis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •chronic statin use
- •positive stress test findings (electrocardiography, nuclear imaging, or stress echocardiography
- •elective angioplasty.
排除标准
- •non-statin therapy
- •any presentation of ACS within 24 hours before the time of randomization
- •current use of potent CYP3A4 inhibitors, including azole antifungals, protease inhibitors, macrolide antibiotics, and cyclosporine
- •renal replacement therapy, a history of kidney transplant, pregnant and with renal failure (serum creatinine > 3.0 mg/dl).
研究组 & 干预措施
Rosuvastatin
40 mg of Rosuvastatin up to 6 hours before elective percutaneous coronary intervention.
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Contrast induce nephropathy defined by serum creatinine increase more than 0.3mg/dl or 50% higher than baseline
时间窗: 48 hours
Serum creatinine increase more than 0.3mg/dl or 50% higher than baseline
次要结局
- Composite end-point ( all cause of death; acute renal failure and no-fatal mayocardial infarctio.(48 hours)
研究者
Kleber Bomfim Araujo Martins
MD,PhD
University of Sao Paulo