NCT01103336已完成4 期
Preventive Effect of the PRetreatment With Intravenous Nicorandil on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndEergoing Coronary Angiography (PRINCIPLE Study): A Investigator-initiated, Control- Randomized, Phase IV Multicenter Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Incidence of contrast-induced nephropathy defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dl
研究概览
简要总结
Renal hypoxia plays an important role in the development of contrast-induced nephropathy. The purpose of the PRINCIPLE study is to investigate the effect of pretreatment with intravenous nicorandil on the incidence of contrast-induced nephropathy in patients with renal insufficiency undergoing coronary angiography.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 20 years
- •Patients undergoing elective coronary angiogram due to documented myocardial ischemia or symptoms of angina
- •Estimated Cr clearance ≤60 mL/min by Cockcroft-Gault formula or serum Cr ≥1.1 mg/dL
- •Signed written informed consent to participate in the study
排除标准
- •Acute myocardial infarction requiring primary or rescue coronary intervention
- •Allergic reaction to contrast dye or nicorandil
- •Cardiogenic shock or significant hypotension
- •Previous use of nicorandil within the preceding 7 days
- •Exposure to contrast medium within the preceding 7 days
- •Pregnancy or women at age of childbearing potential
- •Heart failure (NYHA class III or IV; LV ejection fraction <40% by echocardiogram)
- •Acute renal failure or chronic dialysis
- •Mechanical ventilation
- •History of kidney transplantation
- •Life expectation less than 6 months
- •Previous renal artery angioplasty within the last 6 months
- •Use of nonsteroidal anti-inflammatory drugs, intravenous use of diuretics, dopamine, mannitol, N-acetylcysteine, ascorbic acid or sodium bicarbonate within 48 hrs before the procedure
- •Severe liver disease
研究组 & 干预措施
Nicorandil in saline
Experimental
干预措施: pretreatment with intravenous nicorandil vs. placebo before coronary angiography (Drug)
saline
Placebo Comparator
干预措施: pretreatment with intravenous nicorandil vs. placebo before coronary angiography (Drug)
结局指标
主要结局
Incidence of contrast-induced nephropathy defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dl
时间窗: at 24 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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