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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-08-02', 'releaseDate': '2011-07-05'}], 'estimatedResultsFirstSubmitDate': '2011-07-05'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D004921', 'term': 'Erythropoietin'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'lastUpdateSubmitDate': '2007-01-16', 'studyFirstSubmitDate': '2007-01-16', 'studyFirstSubmitQcDate': '2007-01-16', 'lastUpdatePostDateStruct': {'date': '2007-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-stent Neointimal volume'}, {'measure': 'In-stent Late lumen loss'}, {'measure': 'Semi-Quantitative evaluation of infarcted size of myocardium'}], 'secondaryOutcomes': [{'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)'}]}, 'conditionsModule': {'keywords': ['Acute myocardial infarction', 'Restenosis', 'erythropoietin', 'EPOC-AMI'], 'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '16645141', 'type': 'BACKGROUND', '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.'}, {'pmid': '20834185', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of acute myocardial infarction within 12hrs of symptom onset.\n* Succeeded reperfusion due to primary PCI accomplished bare metal stent\n\nExclusion Criteria:\n\n* Patients with cardiogenic shock (e.g. systolic BP\\<80mmHg,use of catecholamine, use of IABP)\n* Patients with anemia required transfusion\n* Patients who are unwilling or unable to comply with the trial protocol'}, 'identificationModule': {'nctId': 'NCT00423020', 'briefTitle': 'Anti-Restenosis After AMI by Erythropoietin', 'organization': {'class': 'OTHER', 'fullName': 'Kyoto Prefectural University of Medicine'}, 'officialTitle': 'Erythropoietin Prevention Trial of Coronary Restenosis and Cardiac Remodeling After Acute Myocardial Infarction (EPOC-AMI)', 'orgStudyIdInfo': {'id': 'EPOC-AMI 2006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Erythropoietin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '602-8566', 'city': 'Kyoto', 'state': 'Kyoto', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takahisa Sawada, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'tsawada@koto.kpu-m.ac.jp', 'phone': '+81-75-251-5511'}, {'name': 'Hiroaki Matsubara, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'matsubah@koto.kpu-m.ac.jp', 'phone': '+81-75-251-5511'}, {'name': 'Hiroaki Matsubara, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kyoto Prefectural University of Medicine', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}], 'centralContacts': [{'name': 'Takahisa Sawada, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'tsawada@koto.kpu-m.ac.jp', 'phone': '+81-75-251-5511'}, {'name': 'Hiroaki Matsubara, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'matsubah@koto.kpu-m.ac.jp', 'phone': '+81-75-251-5511'}], 'overallOfficials': [{'name': 'Hiroaki Matsubara, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Kyoto Prefectural University of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyoto Prefectural University of Medicine', 'class': 'OTHER'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-07-05', 'type': 'RELEASE'}, {'date': '2011-08-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Kyoto Prefectural University of medicine (Dr. Hiroaki Matsubara)'}}}}