Anti-Restenosis After AMI by Erythropoietin

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Drug: Erythropoietin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of acute myocardial infarction within 12hrs of symptom onset. Succeeded reperfusion due to primary PCI accomplished bare metal stent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Erythropoietin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent Neointimal volume |  |  | 
| In-stent Late lumen loss |  |  | 
| Semi-Quantitative evaluation of infarcted size of myocardium |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute myocardial infarction, Restenosis, erythropoietin, EPOC-AMI