High Dose Atorvastatin Raises Threshold of Contrast Induced Nephropathy in Diabetic Patients Undergoing Elective Coronary Intervention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Contrast Induced Nephropathy (CIN)
研究概览
简要总结
Investigate of the potential benefit of acute pretreatment with high dose atorvastatin (80 mg) in reduction of the incidence of CIN in diabetic patients indicated for elective coronary intervention.
详细描述
The study is a prospective, multi-center, randomized, placebo-controlled study. The ethical committee of the Faculty of Medicine, Assiut University approved the study protocol.
200 diabetic patients with indication for coronary intervention participated in the study. 100 patients were randomly assigned to receive atorvastatin (80 mg) just before coronary intervention (statin group) and 100 patients received placebo (control group). An informed written consent for participating in the study was obtained from each participant.
Exclusion criteria:
- Current statin treatment within the previous three months.
- Chronic renal failure patients on renal dialysis, or serum creatinine more than 1.5 mg/dl.
- Severe co-morbidities i.e. patients with cancer, advanced liver cirrhosis.
- Contraindications to statin therapy.
- Contrast media injection within the preceding 10 days.
- Pregnancy.
- Refusal of consent. (B) Methodology:
All study patients were subjected to:
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •200 diabetic patients with indication for coronary intervention participated in the study
排除标准
- •Current statin treatment within the previous three months.
- •Chronic renal failure patients on renal dialysis, or serum creatinine more than 1.5 mg/dl.
- •Severe co-morbidities i.e. patients with cancer, advanced liver cirrhosis.
- •Contraindications to statin therapy.
- •Contrast media injection within the preceding 10 days.
- •Refusal of consent.
研究组 & 干预措施
Statin group
100 patients were randomly assigned to receive atorvastatin (80 mg) just before coronary intervention
干预措施: Atorvastatin (Drug)
Placebo group
100 patients received placebo
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Contrast Induced Nephropathy (CIN)
时间窗: 48 hours
CIN was defined as a rise of serum creatinine of more than 25% or ≥0.5 mg/dl (44 μmol/l) from baseline within 48 hours of the angiography
次要结局
未报告次要终点
研究者
Mohamed Abdelfatah
investigator
Assiut University