Effects of Edaravone in Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Cardiac Death
研究概览
简要总结
Early reperfusion therapy has improved the clinical outcomes of patients with acute myocardial infarction (AMI), but these benefits are limited in some patients by reperfusion injuries. There is now increasing evidence that reactive oxygen species cause reperfusion injury. This study was designed to examine the effects of edaravone, a novel free radical scavenger, in patients with AMI.
详细描述
Initial AMI patients were randomly assigned to receive 30 mg of edaravone or a placebo intravenously just before reperfusion. We compared infarct size, using serial determination of serum biomarkers and Q wave formations, and the incidence of reperfusion arrhythmia between the groups. Cardiovascular event-free curves were estimated by Kaplan-Meier method. In addition, we determined serum thioredoxin levels, an oxidative stress marker, to assess the antioxidant effect of edaravone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Initial AMI patients admitted to the investigators' institution within 6 hours of symptom onset and treated primary percutaneous coronary intervention.
排除标准
- •Renal insufficiency defined as serum creatinine > 1.2 mg/dl and altered hepatic function defined as serum asparate aminotransferase > 50 IU/L, alanine aminotransferase > 50 IU/L and total bilirubin > 1.2 mg/dl.
研究组 & 干预措施
1
Edaravone Group
干预措施: edaravone (Drug)
结局指标
主要结局
Cardiac Death
时间窗: 415±32 days
number of cardiac death
Nonfatal Myocardial Reinfarction
时间窗: 415days
number of nonfatal myocardial reinfarction
Refractory Angina Pectoris
时间窗: 415days
number of refractory angina pectoris
Nonfatal Ischemic Stroke
时间窗: 415days
number of nonfatal ischemic stroke
次要结局
未报告次要终点