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