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Anti-Restenosis After AMI by Erythropoietin

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ClinicalTrials.gov Identifier: NCT00423020
Recruitment Status : Unknown
Verified January 2007 by Kyoto Prefectural University of Medicine.
Recruitment status was:  Recruiting
First Posted : January 17, 2007
Last Update Posted : January 17, 2007
Sponsor:
Information provided by:

Study Description
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

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Erythropoietin Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Erythropoietin Prevention Trial of Coronary Restenosis and Cardiac Remodeling After Acute Myocardial Infarction (EPOC-AMI)

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. In-stent Neointimal volume
  2. In-stent Late lumen loss
  3. Semi-Quantitative evaluation of infarcted size of myocardium

Secondary Outcome Measures :
  1. left ventricular end diastolic volume
  2. left ventricular end systolic volume
  3. left ventricular ejection fraction
  4. left ventricular wall motion index
  5. binary restenosis
  6. major adverse cardiac events (death,myocardial infarction, target lesion revascularization)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Posted: January 17, 2007    Key Record Dates
Last Update Posted: January 17, 2007
Last Verified: January 2007

Keywords provided by Kyoto Prefectural University of Medicine:
Acute myocardial infarction
Restenosis
erythropoietin
EPOC-AMI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Epoetin Alfa
Hematinics