Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-02-20 @ 6:38 PM
Study NCT ID:
NCT00644657
Status:
COMPLETED
Last Update Posted:
2011-10-07
First Post:
2008-03-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Clopidogrel on Coated-Platelets in Patients Undergoing Cardiac Catheterization
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D002637', 'term': 'Chest Pain'}], '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'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eliot-schechter@ouhsc.edu', 'phone': '405-456-5378', 'title': 'Eliot Schechter, MD', 'organization': 'University of Oklahoma Health Sciences Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limited to primarily Male VA population.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Clopidogrel Loading Dose', 'description': 'All subjects received a 300 mg loading dose of clopidogrel', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percentage of Coated Platelets After the Administration of Clopidogrel in Patients Undergoing Cardiac Catheterization and/or Angioplasty', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clopidogrel Loading Dose', 'description': 'All subjects received a 300 mg loading dose of clopidogrel'}], 'classes': [{'categories': [{'measurements': [{'value': '32.8', 'spread': '13.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours after the administration of clopidotrel', 'description': 'The percentage of platelets that are collagen coated after the administration of clopidogrel.', 'unitOfMeasure': 'Percent of platelets that are coated.', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-12'}, {'type': 'SECONDARY', 'title': 'The Percentage of Coated Platelets After Coronary Angiography and/or PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clopidogrel Loading Dose', 'description': 'All subjects received a 300 mg loading dose of clopidogrel'}], 'classes': [{'categories': [{'measurements': [{'value': '33.9', 'spread': '12.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 hrs after procedure', 'description': 'The percentage of coated platelets 24 hours after coronary angiography and/or PCI', 'unitOfMeasure': 'Percentage of platelets that are coated', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clopidogrel Loading Dose', 'description': 'All subjects received a 300 mg loading dose of clopidogrel'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients scheduled for cardiac catheterization and possible percutaneous intervention who received a loading dose of 300 mg of clopidogrel were recruited.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Clopidogrel', 'description': 'All 27 subjects received a 300 mg loading dose of clopidogrel'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'The percentage of platelets that are "coated-Platelets" as measured by dual-agonist stimulation', 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'spread': '14.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'In each patient the percentage of platelets that are collagen coated will be measured in each patient before clopidogrel administration.', 'unitOfMeasure': 'percent coated platelets', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-07', 'studyFirstSubmitDate': '2008-03-24', 'resultsFirstSubmitDate': '2011-01-06', 'studyFirstSubmitQcDate': '2008-03-26', 'lastUpdatePostDateStruct': {'date': '2011-10-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-07', 'studyFirstPostDateStruct': {'date': '2008-03-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percentage of Coated Platelets After the Administration of Clopidogrel in Patients Undergoing Cardiac Catheterization and/or Angioplasty', 'timeFrame': '24 hours after the administration of clopidotrel', 'description': 'The percentage of platelets that are collagen coated after the administration of clopidogrel.'}], 'secondaryOutcomes': [{'measure': 'The Percentage of Coated Platelets After Coronary Angiography and/or PCI', 'timeFrame': '6 hrs after procedure', 'description': 'The percentage of coated platelets 24 hours after coronary angiography and/or PCI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Platelets, platelet aggregation inhibitors'], 'conditions': ['Coronary Artery Disease', 'Chest Pain']}, 'descriptionModule': {'briefSummary': 'This study will explore the effect of clopidogrel on coated-platelets in patients who are given a loading dose before diagnostic catheterization or percutaneous coronary intervention. We hypothesis that clopidogrel will reduce the percentage of platelets that are coated and therefore more hypercoagulable.', 'detailedDescription': 'Platelet activity will be determined by light transmission aggregometry at baseline, after a 300 mg dose of clopidogrel and after the catheterization and/or angioplasty procedure. The change in the percentage of platelets that are coated platelets will be determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients given clopidogrel loading dose before scheduled catheterization or percutaneous intervention\n\nExclusion Criteria:\n\n* Acute coronary syndrome\n* Unable to tolerate clopidogrel'}, 'identificationModule': {'nctId': 'NCT00644657', 'briefTitle': 'The Effect of Clopidogrel on Coated-Platelets in Patients Undergoing Cardiac Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'The Effect of Clopidogrel on Coated-Platelets in Patients Undergoing Cardiac Catheterization', 'orgStudyIdInfo': {'id': '13291'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Clopidogrel', 'type': 'DRUG', 'otherNames': ['Plavix'], 'description': 'All subjects will receive a 300 mg loading dose'}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104-5076', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'VA Medical Center, 1F187', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Eliot Schechter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}