Anti-Restenosis After AMI by Erythropoietin

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Kyoto Prefectural University of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kyoto Prefectural University of Medicine
ClinicalTrials.gov Identifier:
NCT00423020
First received: January 16, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423020

Contacts
Contact: Takahisa Sawada, M.D., Ph.D. +81-75-251-5511 tsawada@koto.kpu-m.ac.jp
Contact: Hiroaki Matsubara, M.D., Ph.D. +81-75-251-5511 matsubah@koto.kpu-m.ac.jp

Locations
Japan
Kyoto Prefectural University of Medicine Recruiting
Kyoto, Japan, 602-8566
Contact: Takahisa Sawada, M.D., Ph.D.    +81-75-251-5511    tsawada@koto.kpu-m.ac.jp   
Contact: Hiroaki Matsubara, M.D., Ph.D.    +81-75-251-5511    matsubah@koto.kpu-m.ac.jp   
Principal Investigator: Hiroaki Matsubara, M.D., Ph.D.         
Sponsors and Collaborators
Kyoto Prefectural University of Medicine
Investigators
Study Chair: Hiroaki Matsubara, M.D., Ph.D. Kyoto Prefectural University of Medicine
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov 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
Restenosis
erythropoietin
EPOC-AMI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Coronary Restenosis
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Stenosis
Coronary Disease
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 10, 2014