NCT01878344进行中（未招募）3 期
Effects of N-acetyl Cysteine on Major Cardiac and Cerebral Events in Patients Undergoing Primary Percutaneous Coronary Intervention Who Have Moderate to High Risk For Contrast Induced Nephropathy
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
- 100
- 试验地点
- 1
- 主要终点
- Major cardiac and cerebral events
研究概览
简要总结
The aim of this study is to evaluate the effects of N-acetyl cysteine on major cardiac and cerebral events in patients undergoing primary percutaneous coronary intervention who have moderate to high risk for contrast induced nephropathy.
In a sub-group of patients coronary flow reserve will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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 with Acute ST Elevation Myocardial Infarction undergoing Primary Percutaneous Coronary intervention Who Have Moderate to High Risk For Contrast Induced Nephropathy (Mehran Score ≥5)
排除标准
- •Patients >18 years old with moderate to high risk for contrast induced nephropathy undergoing 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
- •Allergy to NAC
- •History of Asthma
- •Chronic nitrate usage
- •Malignancy
- •Use of corticosteroids
- •Leucocytosis,Thrombocytosis,Anemia
- •Blood pressure of >180/100mmHg despite anti-hypertensive therapy
研究组 & 干预措施
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: NAC (Drug)
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)
结局指标
主要结局
Major cardiac and cerebral events
时间窗: 1 year
次要结局
- 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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