Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-28 @ 2:22 PM
Study NCT ID:
NCT01031095
Status:
COMPLETED
Last Update Posted:
2014-01-30
First Post:
2009-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
(A Novel Pharmacologic Regime for Elective Percutaneous Coronary Intervention)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hasanari03@yahoo.com', 'phone': '00902243605050', 'title': 'Dr.Hasan ARI', 'phoneExt': '1739', 'organization': 'Bursa Postgraduate Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The intraprocedural use of a heparinised flush was not controlled; however, given the maximum amount that was allowed to be used, this is not likely to have significantly affected the activated clotting times. .'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Low Dose Intracoronary Heparin', 'description': 'Low dose intracoronary heparin treatment arm', 'otherNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Standard Therapy', 'description': 'standard UFH treatment', 'otherNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'MI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Major Adverse Cardiac Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Therapy', 'description': 'standard UFH treatment (intravenous standard dose unfractioned heparin group)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'unitOfMeasure': 'percentage of event', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Major Adverse Cardiac Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Intracoronary Heparin Treatment Arm', 'description': 'low dose intracoronary heparin treatment arm (intracoronary 1000 IU unfractioned heparin arm)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'unitOfMeasure': 'percentage of event', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Dose Intracoronary Heparin', 'description': 'Low dose intracoronary heparin treatment arm'}, {'id': 'FG001', 'title': 'Standard Therapy', 'description': 'standard unfractionated heparin (UFH) treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Dose Intracoronary Heparin', 'description': 'Low dose intracoronary heparin treatment arm'}, {'id': 'BG001', 'title': 'Standard Therapy', 'description': 'standard UFH treatment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.11', 'spread': '9.68', 'groupId': 'BG000'}, {'value': '58.99', 'spread': '11.24', 'groupId': 'BG001'}, {'value': '59.06', 'spread': '10.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Turkey', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-24', 'studyFirstSubmitDate': '2009-12-11', 'resultsFirstSubmitDate': '2012-01-21', 'studyFirstSubmitQcDate': '2009-12-11', 'lastUpdatePostDateStruct': {'date': '2014-01-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-24', 'studyFirstPostDateStruct': {'date': '2009-12-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiac Events', 'timeFrame': '30 days'}, {'measure': 'Major Adverse Cardiac Event', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['percutaneous coronary intervention', 'low dose intracoronary heparin'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '18929239', 'type': 'BACKGROUND', 'citation': 'Stabile E, Nammas W, Salemme L, Sorropago G, Cioppa A, Tesorio T, Ambrosini V, Campopiano E, Popusoi G, Biondi Zoccai G, Rubino P. The CIAO (Coronary Interventions Antiplatelet-based Only) Study: a randomized study comparing standard anticoagulation regimen to absence of anticoagulation for elective percutaneous coronary intervention. J Am Coll Cardiol. 2008 Oct 14;52(16):1293-8. doi: 10.1016/j.jacc.2008.07.026.'}, {'pmid': '25643432', 'type': 'DERIVED', 'citation': 'Ari H, Kivac E, Ari S, Emlek N, Cetinkaya S, Celiloglu N, Sarigul OY, Aydin C, Akkaya M, Koca V, Bozat T, Gurdogan M. The REDUCED (a RandomisED stUdy Comparing standard systemic anticoagulation thErapy to low Dose intracoronary anticoagulation therapy for elective percutaneous coronary intervention) trial. A novel pharmacologic regime for elective percutaneous coronary intervention. Acta Cardiol. 2014 Dec;69(6):619-27. doi: 10.1080/ac.69.6.1000004.'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis:\n\nLow dose intracoronary unfractionated heparin is as effective and safe as standard dose intravenous unfractionated heparin on patients with elective percutaneous coronary intervention.', 'detailedDescription': 'Aim:\n\nPrimary objective:To evaluate the efficiency and safety of low dose intracoronary unfractioned heparin (UFH) on elective percutaneous coronary intervention (PCI).\n\nSecondary objective:\n\n* To evaluate the effect of low dose intracoronary UFH on myocardial ischemia after PCI.\n* To evaluate the effect of low dose intracoronary UFH on bleeding complications after PCI.\n* To evaluate the cost-effectivity of low dose intracoronary UFH on elective PCI\n\nStudy central:\n\n* Bursa Postgraduate Hospital, Cardiology Clinic\n\nStudy population:\n\n* we planned to enrol 200 patients.\n* Patients will randomise in two groups (control group:100 patients, study group:100 patients)\n\nStudy works:-Write case report form for all patients\n\n* Control for inclusion criteria\n* Demographic data (age, gender)\n* Height, weight, BMI and glomerular filtration rate (GFR)\n* Risk factors\n* laboratory data (biochemical and hematologic)\n* Medication history\n* Echocardiographic data\n* Angiographic data\n* Procedure time\n* PCI data(vessel diameter, stent diameter, lesion and stent length, performed percutaneous transluminal coronary angioplasty (PTCA) or not, etc)\n* Before and after procedure (activated clotting time) ACT value\n* Before and after procedure troponin I (TnI) and Creatine kinase MB (CKMB) levels\n* Note complication (MACE, bleeding, hematoma etc)\n* Note femoral compression time.\n\n 4 weeks later note the first control data.\n\nSix months later note the second control data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients; who have planned elective PCI and have had written informed consent for participation to study.\n* The native coronary artery;\n\n * lesion with narrowing \\>=70%,\n * lesion without thrombus\n * no left main coronary artery (LMCA) lesion\n * no chronic total occlusion lesion\n\nExclusion Criteria:\n\n* Patients have allergy for acetylsalicylic acid (ASA), Clopidogrel and heparin\n* Patients who performed primary PCI\n* Patients with acute coronary syndrome\n* Patients with have a history of myocardial infarction (MI) for two weeks\n* Patients who were use UFH or low molecular weight heparin (LMWH) for 24 hours\n* Patients on warfarin therapy\n* Patients who have bleeding diathesis, or have high risk for bleeding.'}, 'identificationModule': {'nctId': 'NCT01031095', 'acronym': 'REDUCED', 'briefTitle': '(A Novel Pharmacologic Regime for Elective Percutaneous Coronary Intervention)', 'organization': {'class': 'OTHER', 'fullName': 'Bursa Postgraduate Hospital'}, 'officialTitle': 'A RandomisED StUdy Comparing Standard Systemic Anticoagulation ThErapy to Low Dose Intracoronary Anticoagulation Therapy for Elective Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'BYİEAH1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low dose intracoronary heparin', 'description': 'Low dose intracoronary heparin: In this group elective coronary intervention was performed with low dose intracoronary Heparin', 'interventionNames': ['Other: coronary intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard treatment arm', 'description': 'Standard treatment arm: In this group elective coronary intervention performed with standard dose intravenous heparin', 'interventionNames': ['Other: coronary intervention']}], 'interventions': [{'name': 'coronary intervention', 'type': 'OTHER', 'description': 'elective coronary intervention', 'armGroupLabels': ['Low dose intracoronary heparin', 'Standard treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16320', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'overallOfficials': [{'name': 'Hasan Arı, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bursa Postgraduate Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa Postgraduate Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Bursa Postgraduate Hospital', 'investigatorFullName': 'Hasan ARI', 'investigatorAffiliation': 'Bursa Postgraduate Hospital'}}}}