Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT01069302
Status:
COMPLETED
Last Update Posted:
2016-01-11
First Post:
2010-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clopidogrel High Dose Evaluation for the Patient With Coronary Artery Disease in Japan
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-07', 'studyFirstSubmitDate': '2010-02-16', 'studyFirstSubmitQcDate': '2010-02-16', 'lastUpdatePostDateStruct': {'date': '2016-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inhibition of platelet aggregation 24 hours after loading', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Inhibition of platelet aggregation 7 days after loading', 'timeFrame': '7 days'}, {'measure': 'Inhibition of platelet aggregation 28 days after loading', 'timeFrame': '28 days'}, {'measure': 'all cause death', 'timeFrame': '1 year'}, {'measure': 'cardiac death', 'timeFrame': '1 year'}, {'measure': 'myocardial infarction', 'timeFrame': '1 year'}, {'measure': 'stent thrombosis (Academic Research Consortium definition)', 'timeFrame': '1 year'}, {'measure': 'acute hemorrhagic or ischemic stroke excluding transient ischemic attack', 'timeFrame': '1 year'}, {'measure': 'bleeding complications (Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO] and Thrombolysis In Myocardial Infarction [TIMI] definition)', 'timeFrame': '1 year'}, {'measure': 'composite of cardiac death, myocardial infarction and stroke', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary artery disease'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of high dose clopidogrel as the antiplatelet therapy on inhibition of platelet aggregation in Japanese patients scheduled for percutaneous coronary intervention due to ischemic heart disease.', 'detailedDescription': 'Dual antiplatelet therapy of aspirin and thienopyridine is used to prevent stent thrombosis after percutaneous coronary intervention (PCI). Clopidogrel is the most popular thienopyridine. Following the 300mg clopidogrel loading dose (LD) at first day, patients take 75mg maintenance dose (MD) to inhibit platelet aggregation after coronary stent implantation. 600mg high LD inhibit platelet aggregation more rapidly and strongly than standard LD and prevent thrombotic event around the PCI. Similarly high MD inhibit platelet aggregation more strongly. Interindividual variability of clopidogrel anti-platelet effect has been reported. In Japanese, there are many non or hyporesponders to clopidogrel compared to the Western population. The purpose of this study is to evaluate the effect of high dose clopidogrel as the antiplatelet therapy on inhibition of platelet aggregation in Japanese patients scheduled for PCI due to ischemic heart disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for percutaneous coronary intervention due to ischemic heart disease\n* Patients taking aspirin 81-100mg at least 1 week.\n\nExclusion Criteria:\n\n* Patients with ST elevation myocardial infarction\n* Patients have contraindication of aspirin or clopidogrel\n* Patients taking warfarin\n* Patients received thrombolytic therapy within 2 weeks\n* Patients taking anti-platelet agents except aspirin within 1 month\n* Patients taking corticosteroid.\n* Patients taking proton pump inhibitor'}, 'identificationModule': {'nctId': 'NCT01069302', 'acronym': 'CHOICE', 'briefTitle': 'Clopidogrel High Dose Evaluation for the Patient With Coronary Artery Disease in Japan', 'organization': {'class': 'OTHER', 'fullName': 'Kyoto University, Graduate School of Medicine'}, 'officialTitle': 'Clopidogrel High Dose Evaluation for the Patient With Coronary Artery Disease in Japan', 'orgStudyIdInfo': {'id': 'C369'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High loading and high maintenance', 'description': 'Clopidogrel loading 600mg and maintenance 150mg for 7days', 'interventionNames': ['Drug: Clopidogrel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High loading and low maintenance', 'description': 'Clopidogrel loading 600mg and maintenance 75mg for 7days', 'interventionNames': ['Drug: Clopidogrel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low loading and high maintenance', 'description': 'Clopidogrel loading 300mg and maintenance 150mg for 7days', 'interventionNames': ['Drug: Clopidogrel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low loading and low maintenance', 'description': 'Clopidogrel loading 300mg and maintenance 75mg for 7days', 'interventionNames': ['Drug: Clopidogrel']}], 'interventions': [{'name': 'Clopidogrel', 'type': 'DRUG', 'description': 'Clopidogrel loading 600mg and maintenance 150mg for 7days', 'armGroupLabels': ['High loading and high maintenance']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'description': 'Clopidogrel loading 600mg and maintenance 75mg for 7days', 'armGroupLabels': ['High loading and low maintenance']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'description': 'Clopidogrel loading 300mg and maintenance 150mg for 7days', 'armGroupLabels': ['Low loading and high maintenance']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'description': 'Clopidogrel loading 300mg and maintenance 75mg for 7days', 'armGroupLabels': ['Low loading and low maintenance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '606-8507', 'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Division of Cardiology, Kyoto University Hospital', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}], 'overallOfficials': [{'name': 'Takeshi Kimura, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeshi Morimoto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Takeshi Morimoto', 'investigatorAffiliation': 'Kyoto University, Graduate School of Medicine'}}}}