Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT00423020
Status:
UNKNOWN
Last Update Posted:
2007-01-17
First Post:
2007-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anti-Restenosis After AMI by Erythropoietin
Sponsor:
Kyoto Prefectural University of Medicine
Organization:
Study Overview
Official Title:
Erythropoietin Prevention Trial of Coronary Restenosis and Cardiac Remodeling After Acute Myocardial Infarction (EPOC-AMI)
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: