Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction : A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Infarct size as measured by cardiac MRI
研究概览
简要总结
The purpose of this study is to determine whether nicorandil reduce cardiac infarct size in patient with ST-segment elevation acute myocardial infarction.
详细描述
Study objective :
To investiage whether nicorandil treatment reduce infarct size measured by cardiac MRI at 6 months after primary PCI
Allocation :
- Nicorandil arm :
Recieve nicorandil 4 mg i.v. before undergoing PCI, additionall 2mg i.c. just before 1st ballooning, additionall 2mg i.c. just before stenting, After successful PCI, 10 mg/day (or 5 mg/day) p.o. for 6 months. 2. Control arm :
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
- 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
- •STEMI patients presenting within 12 hours after symptom onset
- •Undergoing primary PCI
排除标准
- •Previous myocardial infarction
- •Atrial fibrillation
- •RV infarction
- •Cardiogenic shock
- •Serum creatinine >2.0 mg/dL
- •Narrow angle glaucoma
- •Taking PDE-5 inhibitors
研究组 & 干预措施
Nicorandil
Receive nicorandil before primary PCI and thereafter for 6 months along with the standard therapy.
干预措施: Nicorandil (Drug)
结局指标
主要结局
Infarct size as measured by cardiac MRI
时间窗: Six months after primary PCI
次要结局
- ST-segment resolution(One hour after primary PCI)
- MVO as measured by cardiac MRI(Five days after primary PCI)
- LVEF(%) as measured by cardiac MRI(Five days and 6 months after primary PCI)
- MACE (Death, Spontaneous MI, Stroke)(up to 6 months)
研究者
Jun-Hyok OH
Assistant professor
Pusan National University Hospital