Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-04-17 @ 4:00 AM
Study NCT ID:
NCT01757457
Status:
COMPLETED
Last Update Posted:
2012-12-31
First Post:
2012-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-inflammatory Effects of Intracoronary and Intravenous Abciximab Administration During Primary Percutaneous Coronary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-28', 'studyFirstSubmitDate': '2012-12-19', 'studyFirstSubmitQcDate': '2012-12-28', 'lastUpdatePostDateStruct': {'date': '2012-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in C-reactive protein levels from baseline after PCI', 'timeFrame': '48h', 'description': 'C-reactive protein will be evaluated at admission and 48 hours after the primary PCI as marker of the inflammatory reaction'}], 'secondaryOutcomes': [{'measure': 'Overall Mortality', 'timeFrame': '1year', 'description': 'Mortality for all causes at 1year after primary PCI'}, {'measure': 'Target vessel revascularization', 'timeFrame': '1 year', 'description': 'Target vessel revascularization at 1 year after primary PCI'}, {'measure': 'Myocardial infarction', 'timeFrame': '1 year', 'description': 'Recurrent Myocardial infarction 1 year after PCI'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['inflammation', 'thrombosis', 'platelets', 'adhesion molecules', 'endothelium'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '25022932', 'type': 'DERIVED', 'citation': 'Secco GG, Sansa M, Rognoni A, Parisi R, Fattori R, Rossi L, Lazzero M, Rolla R, Bellomo G, Bongo AS, Agostoni P, Di Mario C, Lupi A. Similar anti-inflammatory effects of intracoronary and intravenous abciximab during primary percutaneous coronary intervention: a randomized study. J Cardiovasc Med (Hagerstown). 2015 Mar;16(3):189-96. doi: 10.2459/JCM.0000000000000119.'}]}, 'descriptionModule': {'briefSummary': 'Intracoronary abciximab administration during primary percutaneous coronary intervention (pPCI) could offer clinical advantages over the intravenous route. The aim of this study was to assess whether abciximab administration route could influence its anti-inflammatory effects. 87 consecutive STEMI patients candidate to pPCI were randomized to receive an intracoronary or intravenous abciximab bolus. The primary endpoint was the extent of inflammation, measured by C-reactive protein (CRP), VCAM-1 and ICAM-1 levels.', 'detailedDescription': 'BACKGROUND: intracoronary abciximab administration during primary percutaneous coronary intervention (pPCI) could offer clinical advantages over the intravenous route. Besides antiplatelet effects, abciximab can modulate inflammation via cross-reactivity with GPIIb/IIIa, avb3, and aMb2 receptors. The aim of this study was to assess whether abciximab administration route could influence its anti-inflammatory effects.\n\nMETHODS: 87 consecutive STEMI patients candidate to pPCI were randomized to receive intracoronary (Group A, 47 patients) or intravenous (Group B, 42 patients) abciximab bolus. The primary endpoint was the extent of inflammation, measured by C-reactive protein (CRP), VCAM-1 and ICAM-1 levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* presence of STEMI according to the universal definition of myocardial infarction (7);\n* hospital admission within 12 hours from symptom onset;\n* successful treatment by primary PCI, defined as a procedure achieving infarct-related artery (IRA) patency with less than 10% residual coronary stenosis based on visual estimation.\n\nExclusion Criteria:\n\n* age \\> 90 years;\n* cardiogenic shock at admission;\n* left main as IRA;\n* saphenous vein graft as IRA;\n* previous PCI in the last 6 months;\n* severe renal impairment (eGFR\\<30ml/min) or dialysis treatment;\n* thrombolytic drug administration in the last 30 days before admission;\n* known malignancy diagnosed less than 5 years before admission;\n* known active infectious, coagulative or systemic inflammatory diseases.'}, 'identificationModule': {'nctId': 'NCT01757457', 'briefTitle': 'Anti-inflammatory Effects of Intracoronary and Intravenous Abciximab Administration During Primary Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero Universitaria Maggiore della Carita'}, 'officialTitle': 'Anti-inflammatory Effects of Intracoronary and Intravenous Abciximab Administration During Primary Percutaneous Coronary Intervention.(Molecole di Adesione Nella Sindrome Coronarica Acuta', 'orgStudyIdInfo': {'id': '0000004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intracoronary abciximab', 'description': 'Intracoronary administration of an abciximab bolus during primary PCI', 'interventionNames': ['Drug: Intracoronary administration of an abciximab bolus during primary PCI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous abciximab', 'description': 'Intravenous standard administration of an abciximab bolus during primary PCI', 'interventionNames': ['Drug: Intravenous administration of an abciximab bolus during primary PCI']}], 'interventions': [{'name': 'Intracoronary administration of an abciximab bolus during primary PCI', 'type': 'DRUG', 'description': 'Intracoronary administration of an abciximab bolus (reopro 0.25mg/kg) during primary PCI', 'armGroupLabels': ['Intracoronary abciximab']}, {'name': 'Intravenous administration of an abciximab bolus during primary PCI', 'type': 'DRUG', 'description': 'Intracoronary administration of an abciximab bolus (reopro 0.25mg/kg) during primary PCI', 'armGroupLabels': ['Intravenous abciximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28100', 'city': 'Novara', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Ospedale Maggiore della Carità ', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}], 'overallOfficials': [{'name': 'Alessandro Lupi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AO Maggiore della Carita'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero Universitaria Maggiore della Carita', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lupi Alessandro', 'investigatorAffiliation': 'Azienda Ospedaliero Universitaria Maggiore della Carita'}}}}