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临床试验/NCT00212030
NCT00212030已完成不适用

Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP

National Cerebral and Cardiovascular Center, Japan1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2001年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
600
试验地点
1
主要终点
estimated infarct size

研究概览

简要总结

To evaluate whether nicorandil as an adjunctive therapy for AMI reduces myocardial infarct size and improves regional wall motion

详细描述

The benefits of percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI) are limited by reperfusion injury. In animal models, nicorandil, a hybrid of an ATP-sensitive K+ (KATP) channel opener and nitrates, reduces infarct size, so the Japan-Working groups of acute myocardial Infarction for the reduction of Necrotic Damage by a K-ATP channel opener (J-WIND-KATP) designed a prospective, randomized, multicenter study to evaluate whether nicorandil reduces myocardial infarct size and improves regional wall motion when used as an adjunctive therapy for AMI.

Twenty-six hospitals in Japan are participating in the J-WIND-KATP study. Patients with AMI who are candidates for PCI are randomly allocated to receive either intravenous nicorandil or placebo. The primary end-points are (1) estimated infarct size and (2) left ventricular function. Single nucleotide polymorphisms (SNPs) that may be associated with the function of KATP-channel and the susceptibility of AMI to the drug will be examined. Furthermore, a data mining method will be used to design the optimal combined therapy for post-myocardial infarction (MI) patients.

It is intended that J-WIND-KATP will provide important data on the effects of nicorandil as an adjunct to PCI for AMI and that the SNPs information that will open the field of tailor-made therapy. The optimal therapeutic drug combination will also be determined for post-MI patients.

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 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20-79 years
  • Chest pain of more than 30 min
  • 0.1 mV ST-segment elevation in 2 contiguous ECG leads
  • Admission to hospital within 12 h of symptom onset
  • First episode of AMI
  • Candidates for PCI

排除标准

  • History of old myocardial infarction
  • Left main coronary artery stenosis
  • Severe liver and/or kidney dysfunction
  • Suspected aortic dissection
  • History of coronary artery bypass graft
  • History of allergic response to drugs
  • Severe hypovolemia
  • Right ventricular infarction

研究组 & 干预措施

1

Active Comparator

干预措施: nicorandil (Drug)

2

Placebo Comparator

干预措施: placebo (Drug)

结局指标

主要结局

estimated infarct size

时间窗: 72hrs

left ventricular function (left ventricular ejection fraction and end-diastolic volume) and regional wall motion

时间窗: 2-8weeks and 6-12months

次要结局

  • survival rate(2.7years (median follow-up))
  • cardiovascular events (ie, cardiac death, nonfatal re-infarction, re-hospitalization because of cardiac disease, revascularization)(2.7years (median follow-up))
  • reperfusion injury (ie, malignant ventricular arrhythmia during reperfusion periods, re-elevation of ST-segment, worsening of chest pain)(24hrs)
  • the association of SNPs of ANP-related genes with response to ANP treatment(2.7years (median follow-up))

研究者

发起方
National Cerebral and Cardiovascular Center, Japan
申办方类型
Other

研究点 (1)

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