Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 12:55 AM
Study NCT ID:
NCT00138034
Status:
COMPLETED
Last Update Posted:
2012-04-30
First Post:
2005-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
APRICOT-3: Antithrombotics in the Prevention of Reocclusion In COronary Thrombolysis -3
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], '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'}]}, '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': 'f.verheugt@cardio.umcn.nl', 'phone': '+31(0)24-3614533', 'title': 'Professor Doctor F.W.A. Verheugt', 'organization': 'Radboud University Medical Center Nijmegen'}, 'certainAgreement': {'otherDetails': 'Freek W.A. Verheugt\n\nhas to following potential conflict of interest:\n\n1. received educational and research grants from Bayer Healthcare, Roche, Eli Lilly and Boehringer Ingelheim\n2. received honoraria for consultancies from Daiichi-Sankyo, Eli Lilly, Merck, The Medicines Company and Bayer Healthcare', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Percutaeous Coronary Intervention (PCI)', 'description': 'Stenting of culprit lesion followed by dual antiplatelet therapy', 'otherNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Conservative Treatment', 'description': 'Conservative treatment of culprit lesion with dual antiplatelet therapy', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'intracerebral bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '6-month Reocclusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Percutaeous Coronary Intervention (PCI)', 'description': 'Stenting of culprit lesion followed by dual antiplatelet therapy'}, {'id': 'OG001', 'title': 'Conservative Treatment', 'description': 'Conservative treatment of culprit lesion with dual antiplatelet therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Less than TIMI (Thrombolysis In Myocardial Infarction) -3 flow of the infarct related coronary artery assessed at follow-up angiography', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Composite of Death, Reinfarction, Stroke and Revascularization at the Time of Follow-up Angiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Percutaeous Coronary Intervention (PCI)', 'description': 'Stenting of culprit lesion followed by dual antiplatelet therapy'}, {'id': 'OG001', 'title': 'Conservative Treatment', 'description': 'Conservative treatment of culprit lesion with dual antiplatelet therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'The occurence of any one of the above mentioned outcome measures. Only the first event per patient is counted.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Percutaeous Coronary Intervention (PCI)', 'description': 'Stenting of culprit lesion followed by dual antiplatelet therapy'}, {'id': 'FG001', 'title': 'Conservative Treatment', 'description': 'Conservative treatment of culprit lesion with dual antiplatelet therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Patients were included from 1 january 2005 until december 2009'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Percutaeous Coronary Intervention (PCI)', 'description': 'Stenting of culprit lesion followed by dual antiplatelet therapy'}, {'id': 'BG001', 'title': 'Conservative Treatment', 'description': 'Conservative treatment of culprit lesion with dual antiplatelet therapy'}, {'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': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '12', 'groupId': 'BG000'}, {'value': '59', 'spread': '13', 'groupId': 'BG001'}, {'value': '59', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-25', 'studyFirstSubmitDate': '2005-08-29', 'resultsFirstSubmitDate': '2012-02-20', 'studyFirstSubmitQcDate': '2005-08-29', 'lastUpdatePostDateStruct': {'date': '2012-04-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-29', 'studyFirstPostDateStruct': {'date': '2005-08-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-month Reocclusion', 'timeFrame': '6 months', 'description': 'Less than TIMI (Thrombolysis In Myocardial Infarction) -3 flow of the infarct related coronary artery assessed at follow-up angiography'}], 'secondaryOutcomes': [{'measure': 'Composite of Death, Reinfarction, Stroke and Revascularization at the Time of Follow-up Angiography', 'timeFrame': '6 months', 'description': 'The occurence of any one of the above mentioned outcome measures. Only the first event per patient is counted.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Open infarct-related artery within 72 hours of thrombolysis'], 'conditions': ['Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Reocclusion of the infarct artery is observed in about 30% of patients within three months after successful thrombolysis for acute myocardial infarction (MI). Reocclusion is associated with an increased risk of death, reinfarction and the need for revascularization. Even in the absence of clinical reinfarction, reocclusion results in impaired left ventricular (LV) recovery, leaving patients at increased risk of developing heart failure in the long-term. Prevention of reocclusion is therefore warranted. In previous trials, severity of the infarct related stenosis was the only independent predictor of reocclusion. With a lack of clinical predictors of reocclusion, many cardiologists therefore empirically favor routine revascularization after successful thrombolysis.\n\nThe APRICOT-3 will be the first randomized trial in the current era of improved angioplasty techniques to study the question of whether a routine invasive strategy after successful thrombolysis can reduce the incidence of reocclusion and subsequently improve clinical outcome and LV-function. After successful thrombolysis, patients will be randomized to either a routine invasive strategy or an ischemia-guided strategy. The investigators expect to demonstrate a lower reocclusion rate at the 6-month follow-up angiography (primary endpoint) and fewer associated events (death, reinfarction, revascularization, admissions for heart failure) in the routine invasive arm. In search of non-invasive parameters predictive of reocclusion, laboratory analysis of several coagulation and inflammatory markers will be performed. Finally, pooled analysis of all 3 APRICOT trials will focus on the identification of clinical predictors of reocclusion that can easily be obtained by history and physical examination.', 'detailedDescription': 'Randomized controlled study of elective percutaneous coronary intervention (PCI) of an open culprit lesion after fibrinolysis for ST-elevation myocardial infarction (STEMI)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* TIMI-3 in infarct-related artery with a stentable lesion with 72 hours of thrombolysis for ST-elevation myocardial infarction\n\nExclusion Criteria:\n\n* Use of oral anticoagulants.\n* Known intolerance to aspirin or clopidogrel.\n* Bypass graft as infarct-related artery.\n* Previously dilated infarct related artery.\n* Significant left main stenosis.\n* Unidentifiable culprit stenosis.'}, 'identificationModule': {'nctId': 'NCT00138034', 'briefTitle': 'APRICOT-3: Antithrombotics in the Prevention of Reocclusion In COronary Thrombolysis -3', 'organization': {'class': 'OTHER', 'fullName': 'Heartcenter, University Medical Center St. Radboud'}, 'officialTitle': 'A Multicenter Randomized Trial in the Prevention of Reocclusion Following Successful Thrombolysis for Suspected Acute Myocardial Infarction: An Invasive Versus a Conservative Strategy', 'orgStudyIdInfo': {'id': 'APRICOT-3'}, 'secondaryIdInfos': [{'id': '2003B257', 'type': 'OTHER', 'domain': 'Netherlands Heart Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Percutaneous coronary intervention (PCI)', 'description': 'Stenting of the culprit lesion of the infarct related artery and aspirin and clopidorgel for at least 6 months', 'interventionNames': ['Procedure: Percutaneous coronary intervention (PCI)']}, {'type': 'OTHER', 'label': 'Dual antiplatelet therapy', 'description': 'Aspirin and clopidogrel for at least 6 months', 'interventionNames': ['Procedure: Percutaneous coronary intervention (PCI)']}], 'interventions': [{'name': 'Percutaneous coronary intervention (PCI)', 'type': 'PROCEDURE', 'otherNames': ['bare metal stent placement'], 'description': 'PCI with bare metal stent placement of the culprit lesion the in the infarct related artery', 'armGroupLabels': ['Dual antiplatelet therapy', 'Percutaneous coronary intervention (PCI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500 HB', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Radboud University Nijmegen Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Freek WA Verheugt, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Nijmegen Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heartcenter, University Medical Center St. Radboud', 'class': 'OTHER'}, 'collaborators': [{'name': 'Netherlands Heart Foundation', 'class': 'OTHER'}, {'name': 'The Interuniversity Cardiology Institute of the Netherlands', 'class': 'OTHER_GOV'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}, {'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Cardiology', 'investigatorFullName': 'Prof. Dr. F.W.A. Verheugt', 'investigatorAffiliation': 'Heartcenter, University Medical Center St. Radboud'}}}}