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Anti-Restenosis After AMI by Erythropoietin

Primary Purpose

Acute Myocardial Infarction

Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Erythropoietin
Sponsored by
Kyoto Prefectural University of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute myocardial infarction, Restenosis, erythropoietin, EPOC-AMI

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyoto Prefectural University of MedicineRecruiting

Outcomes

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)

Full Information

First Posted
January 16, 2007
Last Updated
January 16, 2007
Sponsor
Kyoto Prefectural University of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00423020
Brief Title
Anti-Restenosis After AMI by Erythropoietin
Official Title
Erythropoietin Prevention Trial of Coronary Restenosis and Cardiac Remodeling After Acute Myocardial Infarction (EPOC-AMI)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Kyoto Prefectural University of Medicine

4. Oversight

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Acute myocardial infarction, Restenosis, erythropoietin, EPOC-AMI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
72 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Erythropoietin
Primary Outcome Measure Information:
Title
In-stent Neointimal volume
Title
In-stent Late lumen loss
Title
Semi-Quantitative evaluation of infarcted size of myocardium
Secondary Outcome Measure Information:
Title
left ventricular end diastolic volume
Title
left ventricular end systolic volume
Title
left ventricular ejection fraction
Title
left ventricular wall motion index
Title
binary restenosis
Title
major adverse cardiac events (death,myocardial infarction, target lesion revascularization)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takahisa Sawada, M.D., Ph.D.
Phone
+81-75-251-5511
Email
tsawada@koto.kpu-m.ac.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Hiroaki Matsubara, M.D., Ph.D.
Phone
+81-75-251-5511
Email
matsubah@koto.kpu-m.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroaki Matsubara, M.D., Ph.D.
Organizational Affiliation
Kyoto Prefectural University of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takahisa Sawada, M.D., Ph.D.
Phone
+81-75-251-5511
Email
tsawada@koto.kpu-m.ac.jp
First Name & Middle Initial & Last Name & Degree
Hiroaki Matsubara, M.D., Ph.D.
Phone
+81-75-251-5511
Email
matsubah@koto.kpu-m.ac.jp
First Name & Middle Initial & Last Name & Degree
Hiroaki Matsubara, M.D., Ph.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
16645141
Citation
Urao N, Okigaki M, Yamada H, Aadachi Y, Matsuno K, Matsui A, Matsunaga S, Tateishi K, Nomura T, Takahashi T, Tatsumi T, Matsubara H. Erythropoietin-mobilized endothelial progenitors enhance reendothelialization via Akt-endothelial nitric oxide synthase activation and prevent neointimal hyperplasia. Circ Res. 2006 Jun 9;98(11):1405-13. doi: 10.1161/01.RES.0000224117.59417.f3. Epub 2006 Apr 27.
Results Reference
background
PubMed Identifier
20834185
Citation
Taniguchi N, Nakamura T, Sawada T, Matsubara K, Furukawa K, Hadase M, Nakahara Y, Nakamura T, Matsubara H. Erythropoietin prevention trial of coronary restenosis and cardiac remodeling after ST-elevated acute myocardial infarction (EPOC-AMI): a pilot, randomized, placebo-controlled study. Circ J. 2010 Nov;74(11):2365-71. doi: 10.1253/circj.cj-10-0267. Epub 2010 Sep 8.
Results Reference
derived

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Anti-Restenosis After AMI by Erythropoietin

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