跳至主要内容
临床试验/NCT00423020
NCT00423020Unknown4 期

Erythropoietin Prevention Trial of Coronary Restenosis and Cardiac Remodeling After Acute Myocardial Infarction (EPOC-AMI)

Kyoto Prefectural University of Medicine2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2007年1月17日最近更新:
适应症
相关药物

试验速览

阶段
4 期
入组人数
72
试验地点
2
主要终点
In-stent Neointimal volume

研究概览

简要总结

The EPOC-AMI study is to assess the safety and the efficacy of systemic administration of erythropoietin for inhibition of neointimal hyperplasia after stent implantation in the patients with acute myocardial infarction

详细描述

Stents coated with sirolimus or paclitaxel have been shown to significantly reduce restenosis in selected coronary lesions. However, the potential risk of late stent thrombosis forces prolonged treatment of dual anti-platelet regimen to all the patients after implantation of drug eluting stents. Patients with acute myocardial infarction may have uncertain clinical characteristics, such as occult bleeding focus or further need for surgical procedures. Thus, bare metal stent is considerably alternative for primary PCI after AMI and there remain an appreciable number of patients at risk for restenosis. Use of systemic pharmacological therapy to inhibit coronary stent restenosis of bare metal stent has been largely unsuccessful. We have reported that erythropoietin could enhance reendothelialization leading to inhibition of in-stent restenosis by directly protecting endothelial apoptosis and mobilizing endothelial progenitors. The EPOC-AMI study is designed to assess the safety and the efficacy of systemic administration of erythropoietin aiming inhibition of neointimal hyperplasia after stent implantation in the patients with acute myocardial infarction.

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
Double

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

  • Clinical diagnosis of acute myocardial infarction within 12hrs of symptom onset.
  • Succeeded reperfusion due to primary PCI accomplished bare metal stent

排除标准

  • Patients with cardiogenic shock (e.g. systolic BP<80mmHg,use of catecholamine, use of IABP)
  • Patients with anemia required transfusion
  • Patients who are unwilling or unable to comply with the trial protocol

结局指标

主要结局

In-stent Neointimal volume

In-stent Late lumen loss

Semi-Quantitative evaluation of infarcted size of myocardium

次要结局

  • left ventricular end diastolic volume
  • left ventricular end systolic volume
  • left ventricular ejection fraction
  • left ventricular wall motion index
  • binary restenosis
  • major adverse cardiac events (death,myocardial infarction, target lesion revascularization)

研究者

申办方类型
Other

研究点 (2)

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