NCT00423020

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 17, 2007

Completed
Last Updated

January 17, 2007

Status Verified

January 1, 2007

First QC Date

January 16, 2007

Last Update Submit

January 16, 2007

Conditions

Keywords

Acute myocardial infarctionRestenosiserythropoietinEPOC-AMI

Outcome Measures

Primary Outcomes (3)

  • In-stent Neointimal volume

  • In-stent Late lumen loss

  • Semi-Quantitative evaluation of infarcted size of myocardium

Secondary Outcomes (6)

  • left ventricular end diastolic volume

  • left ventricular end systolic volume

  • left ventricular ejection fraction

  • left ventricular wall motion index

  • binary restenosis

  • +1 more secondary outcomes

Interventions

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of acute myocardial infarction within 12hrs of symptom onset.
  • Succeeded reperfusion due to primary PCI accomplished bare metal stent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyoto Prefectural University of Medicine

Kyoto, Kyoto, 602-8566, Japan

RECRUITING

Related Publications (2)

  • 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.

    PMID: 16645141BACKGROUND
  • 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.

MeSH Terms

Interventions

Erythropoietin

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Hiroaki Matsubara, M.D., Ph.D.

    Kyoto Prefectural University of Medicine

    STUDY CHAIR

Central Study Contacts

Takahisa Sawada, M.D., Ph.D.

CONTACT

Hiroaki Matsubara, M.D., Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 16, 2007

First Posted

January 17, 2007

Last Updated

January 17, 2007

Record last verified: 2007-01

Locations