NCT00770796已完成4 期
Usefulness of Atorvastatin (80 mg) in Prevention of Contrast-Induced Nephropathy in Patients With Chronic Renal Disease
Ospedale Misericordia e Dolce0 个研究点目标入组 304 人开始时间: 2006年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 304
- 主要终点
- Contrast-induced nephropathy was defined as an absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration within the first 24 hours after contrast exposure and peaking up to 5 days afterwards
研究概览
简要总结
In this randomized study the investigators wish to explore the role of pre-procedural statin therapy for the prevention of contrast induced nephropathy in patients with moderate-to-severe renal dysfunction, submitted to elective coronary or angioplasty.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with pre-angiographic estimated creatinine clearance < 60 ml/min
排除标准
- •contrast medium administration within the previous 10 days
- •end-stage renal failure requiring dialysis
- •refusal to give informed consent
- •previous therapy with statin
研究组 & 干预措施
Placebo
Placebo Comparator
placebo
干预措施: Placebo (Drug)
Atorvastatin
Active Comparator
80 mg die of Atorvastatin given at least two days before elective angiography or angioplasty and continued for two days after.
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Contrast-induced nephropathy was defined as an absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration within the first 24 hours after contrast exposure and peaking up to 5 days afterwards
时间窗: within 5 days after contrast exposure
次要结局
- Relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration(within 5 days after contrast agent administration)
- Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration(1 month)
研究者
Mauro Maioli
MD
Ospedale Misericordia e Dolce
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