Anti-Restenosis After AMI by Erythropoietin

Acute Myocardial Infarction Clinical Trial

Official title:

Erythropoietin Prevention Trial of Coronary Restenosis and Cardiac Remodeling After Acute Myocardial Infarction (EPOC-AMI)

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00423020
• Other study ID #: EPOC-AMI 2006
• Status: Unknown status
• Phase: Phase 4
• First received: January 16, 2007
• Last updated: January 16, 2007

Study information

• Verified date: January 2007
• Source: Kyoto Prefectural University of Medicine
• Contact: Takahisa Sawada, M.D., Ph.D.
• Phone: +81-75-251-5511
• Email: tsawada[@]koto.kpu-m.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 72
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Erythropoietin

Locations

Country	Name	City	State
Japan	Kyoto Prefectural University of Medicine	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Kyoto Prefectural University of Medicine

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. Epub 2006 Apr 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent Neointimal volume
Primary	In-stent Late lumen loss
Primary	Semi-Quantitative evaluation of infarcted size of myocardium
Secondary	left ventricular end diastolic volume
Secondary	left ventricular end systolic volume
Secondary	left ventricular ejection fraction
Secondary	left ventricular wall motion index
Secondary	binary restenosis
Secondary	major adverse cardiac events (death,myocardial infarction, target lesion revascularization)