Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT00693069
Status:
COMPLETED
Last Update Posted:
2012-08-21
First Post:
2008-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Different Dosing Regimens of Clopidogrel Before Elective Percutaneous Coronary Intervention (PCI) on Platelet Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000077144', 'term': 'Clopidogrel'}], 'ancestors': [{'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-20', 'studyFirstSubmitDate': '2008-06-03', 'studyFirstSubmitQcDate': '2008-06-05', 'lastUpdatePostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of this study was to evaluate the effect of four different dosing regimens of clopidogrel on platelet aggregation at the time of diagnostic coronary angiography, and 2 hours after stenting.', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'A secondary objective in patients stented was the 30-day incidence of the composite of death, myocardial infarction (MI) or urgent target vessel revascularization.', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['angioplasty', 'clopidogrel', 'coronary artery disease', 'platelets', 'Percutaneous coronary intervention'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Adequate platelet inhibition before percutaneous coronary intervention (PCI) reduces peri-procedural and long-term ischemic complications. Documented reduced response to clopidogrel has been associated with subsequent major adverse cardiovascular events. Strategies to optimize platelet inhibition pre-PCI are under investigation.\n\nThis study sought to evaluate the effect on platelet aggregation of four different dosing regimens of clopidogrel given before elective PCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient with an indication for elective coronary angiography with or without PCI\n\nExclusion Criteria:\n\n* major hemorrhagic diathesis or active bleeding\n* acute myocardial infarction (MI) within 14 days of enrolment\n* unstable angina with ST-segment changes \\>1 mm in at least two contiguous electrocardiographic leads at rest or a troponin I level \\>0.06 microg/L within 14 days of enrolment\n* stroke within the past 3 months\n* platelet count \\<100 x 10 9/L\n* prothrombin time \\> 1.5 times control\n* hematocrit \\<25% or hemoglobin level \\<100 g/L\n* alcohol or drug abuse\n* enrolment in other investigational drug trials within the previous month\n* use of thienopyridines, glycoprotein (GP) IIb/IIIa inhibitors, warfarin or acenocoumarol within the previous week\n* allergic reaction or any contraindication to clopidogrel or aspirin administration'}, 'identificationModule': {'nctId': 'NCT00693069', 'briefTitle': 'Effect of Different Dosing Regimens of Clopidogrel Before Elective Percutaneous Coronary Intervention (PCI) on Platelet Function', 'organization': {'class': 'OTHER', 'fullName': "Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal"}, 'officialTitle': 'Effect of Different Dosing Regimens of Clopidogrel Given Before Elective Percutaneous Coronary Intervention on Platelet Function', 'orgStudyIdInfo': {'id': 'C.E.2004-06-24A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Clopidogrel 300 mg the day before PCI', 'interventionNames': ['Drug: Clopidogrel']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Clopidogrel 600 mg the day before PCI', 'interventionNames': ['Drug: Clopidogrel']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': '300 mg followed by 75 mg daily started one week prior to angiography', 'interventionNames': ['Drug: Clopidogrel']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': '300 mg followed by 150 mg daily started one week prior to angiography', 'interventionNames': ['Drug: Clopidogrel']}], 'interventions': [{'name': 'Clopidogrel', 'type': 'DRUG', 'description': 'clopidogrel 300 mg on the day prior to angiography', 'armGroupLabels': ['1']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'description': 'clopidogrel 600 mg on the day prior to angiography', 'armGroupLabels': ['2']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'description': 'clopidogrel 300 mg followed by 75 mg daily started one week prior to angiography', 'armGroupLabels': ['3']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'description': 'clopidogrel 300 mg followed by 150 mg daily started one week prior to angiography', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital du Sacre-Coeur de Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Jean G Diodati, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jean G Diodati, MD', 'oldOrganization': 'Hopital du Sacre-Coeur de Montreal'}}}}