NCT01878669进行中（未招募）3 期
Effects of N-acetyl Cysteine on Periprocedural Myocardial Infarction and Major Cardiac and Cerebral Events in Patients Undergoing Percutaneous Coronary Intervention
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- periprocedural myocardial infarction
研究概览
简要总结
The aim of this study is to evaluate the effects of N-acetyl cysteine on periprocedural myocardial infarction and major cardiac and cerebral events in patients undergoing percutaneous coronary intervention and who have moderate to high risk for contrast induced nephropathy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years old undergoing percutaneous coronary intervention and who have moderate to high risk for contrast induced nephropathy (Mehran Score ≥ 5)
排除标准
- •Primary percutaneous coronary intervention
- •Low risk for contrast induced nephropathy (Mehran Score < 5)
- •Use of nephrotoxic agents (NSAIDs, aminoglycosides,recent contrast injection...)
- •Infection
- •Pregnancy, Lactation
- •Renal failure requiring dialysis
- •Hepatic failure
- •History allergy for NAC
- •History of Asthma
- •Chronic nitrate usage
- •Malignancy
- •Use of corticosteroids
- •Leukocytosis,Thrombocytosis,Anemia
- •Blood pressure of >180/100mmHg despite anti-hypertensive therapy
研究组 & 干预措施
saline
Placebo Comparator
30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure
干预措施: Saline (Drug)
n-acetyl cysteine
Experimental
30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure
干预措施: N-acetyl cysteine (Drug)
结局指标
主要结局
periprocedural myocardial infarction
时间窗: postprocedural 3-6 h
次要结局
- major cardiac and cerebral events(1 year follow-up)
- NAC side effects (Asthma exacerbation, pruritus, dyspnea)(during hospitalization at 48 hours)
研究者
Mehmet Ozaydin, MD
MD, Professor
Suleyman Demirel University
研究点 (1)
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