Anti-Restenosis After AMI by Erythropoietin

Phase 4

• Conditions: Acute Myocardial Infarction

• Registration Number: NCT00423020
• Lead Sponsor: Kyoto Prefectural University of Medicine

Brief Summary

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

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.

Study Timeline

• Status Verified: 2007-01
• Study First Submitted: 2007-01-16
• Study First Submitted QC: 2007-01-16
• Last Update Submitted: 2007-01-16
• Study First Posted: 2007-01-17
• Last Update Posted: 2007-01-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
In-stent Neointimal volume
In-stent Late lumen loss
Semi-Quantitative evaluation of infarcted size of myocardium

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Kyoto Prefectural University of Medicine; 🇯🇵 Kyoto, Japan