Clinical trial NCT00423020: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Keywords: Acute myocardial infarction
Restenosis
erythropoietin
EPOC-AMI
Lead sponsor: Kyoto Prefectural University of Medicine
Sponsor class: OTHER
First posted: 2007-01-17
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: In-stent Neointimal volume
measure: In-stent Late lumen loss
measure: Semi-Quantitative evaluation of infarcted size of myocardium
Secondary outcomes:
measure: left ventricular end diastolic volume
measure: left ventricular end systolic volume
measure: left ventricular ejection fraction
measure: left ventricular wall motion index
measure: binary restenosis
measure: major adverse cardiac events (death,myocardial infarction, target lesion revascularization)
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Kyoto Prefectural University of Medicine
Study officials:
affiliation: Kyoto Prefectural University of Medicine
name: Hiroaki Matsubara, M.D., Ph.D.
role: STUDY_CHAIR
References:
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.
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.