Anti-Restenosis After AMI by Erythropoietin

January 16, 2007 updated by: Kyoto Prefectural University of Medicine

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

72

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
      • Kyoto, Japan, 602-8566
        • Recruiting
        • Kyoto Prefectural University of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hiroaki Matsubara, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyoto Prefectural University of Medicine

Investigators

  • Study Chair: Hiroaki Matsubara, M.D., Ph.D., Kyoto Prefectural University of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 16, 2007

First Submitted That Met QC Criteria

January 16, 2007

First Posted (Estimate)

January 17, 2007

Study Record Updates

Last Update Posted (Estimate)

January 17, 2007

Last Update Submitted That Met QC Criteria

January 16, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPOC-AMI 2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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