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Anti-Restenosis After AMI by Erythropoietin

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by Kyoto Prefectural University of Medicine.
Recruitment status was:  Recruiting
Information provided by:
Kyoto Prefectural University of Medicine Identifier:
First received: January 16, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
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

Condition Intervention Phase
Acute Myocardial Infarction
Drug: Erythropoietin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Erythropoietin Prevention Trial of Coronary Restenosis and Cardiac Remodeling After Acute Myocardial Infarction (EPOC-AMI)

Resource links provided by NLM:

Further study details as provided by Kyoto Prefectural University of Medicine:

Primary Outcome Measures:
  • In-stent Neointimal volume
  • In-stent Late lumen loss
  • Semi-Quantitative evaluation of infarcted size of myocardium

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 72
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.

Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00423020

Kyoto Prefectural University of Medicine
Kyoto, Japan, 602-8566
Sponsors and Collaborators
Kyoto Prefectural University of Medicine
Study Chair: Hiroaki Matsubara, M.D., Ph.D. Kyoto Prefectural University of Medicine
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00423020     History of Changes
Other Study ID Numbers: EPOC-AMI 2006 
Study First Received: January 16, 2007
Last Updated: January 16, 2007
Health Authority: Japan: Institutional Review Board

Keywords provided by Kyoto Prefectural University of Medicine:
Acute myocardial infarction

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Epoetin Alfa
Hematinics processed this record on January 17, 2017