Acute Myocardial Infarction
Conditions
Keywords
Acute myocardial infarction, Restenosis, erythropoietin, EPOC-AMI
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.
Interventions
DRUGErythropoietin
Sponsors
Kyoto Prefectural University of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-stent Neointimal volume | — |
| In-stent Late lumen loss | — |
| Semi-Quantitative evaluation of infarcted size of myocardium | — |
Secondary
| Measure | Time frame |
|---|---|
| left ventricular wall motion index | — |
| left ventricular end diastolic volume | — |
| major adverse cardiac events (death,myocardial infarction, target lesion revascularization) | — |
| binary restenosis | — |
| left ventricular end systolic volume | — |
| left ventricular ejection fraction | — |
Countries
Japan
Contacts
Primary ContactTakahisa Sawada, M.D., Ph.D.
Backup ContactHiroaki Matsubara, M.D., Ph.D.
Outcome results
None listed