Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT01023360
Status:
UNKNOWN
Last Update Posted:
2009-12-02
First Post:
2008-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Antiplatelet Drug Resistance in Taiwanese With VASP & Platelet Mapping ™ Assay
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D054328', 'term': 'Proton Pump Inhibitors'}, {'id': 'D064750', 'term': 'Rabeprazole'}, {'id': 'D000077402', 'term': 'Pantoprazole'}, {'id': 'D064098', 'term': 'Esomeprazole'}], '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'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D009853', 'term': 'Omeprazole'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-12-01', 'studyFirstSubmitDate': '2008-08-07', 'studyFirstSubmitQcDate': '2009-12-01', 'lastUpdatePostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the antiplatelet drug response apparently shown in TEG & Platelet mapping assay', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['30 Healthy People']}, 'descriptionModule': {'briefSummary': 'Currently, drugs commonly used for antiplatelet are aspirin and clopidogrel when encountering stroke or coronary heart disease. In this study, we would use VASP assay and thromboelastograph with platelet mapping assay kit to evaluate the antiplatelet resistance in general population and the relationship between clopidogrel and proton pump inhibitor.', 'detailedDescription': 'This study intent is to search the standard to diagnose of the antiplatelet drug resistance and to discover the prevalence of drug resistance in Taiwanese population in Taiwan. The trial will enroll at least 30 healthy people after fulfilling the investigation questionnaire. All the participants will receive antiplatelet drugs in two separate period and measured the efficacy by VASP assay and thromboelastograph with platelet mapping assay. The health volunteer will receive clopidogrel and different types of proton pump inhibitor to see the interference of antiplatelet efficacy between each drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 30 Healthy people, without major systemic disease, not under medication treatment\n\nExclusion Criteria:\n\n* Systemic disease, under medication control with NSAID, anticoagulants, taking antiplatelet drugs before entering trial, Chinese herb, pregnant or breast feeding woman'}, 'identificationModule': {'nctId': 'NCT01023360', 'briefTitle': 'Evaluation of Antiplatelet Drug Resistance in Taiwanese With VASP & Platelet Mapping ™ Assay', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Evaluation of Antiplatelet Drug Resistance in Taiwanese With VASP & Platelet Mapping™ Assay', 'orgStudyIdInfo': {'id': '200804034R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clopidogrel and proton pump inhibitors', 'description': 'all participating healthy people should receive clopidogrel and 3 kinds of PPI sequentially with one week interval between each PPI.', 'interventionNames': ['Drug: Clopidogrel and proton pump inhibitors']}], 'interventions': [{'name': 'Clopidogrel and proton pump inhibitors', 'type': 'DRUG', 'otherNames': ['clopidogrel', 'rabeprazole', 'pantoprazole', 'esomeprazole'], 'description': 'baseline detection --\\> clopidogrel 75 mg PO QD for 1 week --\\> clopidogrel 75 mg plus rabeprazole 20mg PO QD for 1 week --\\> clopidogrel 75 mg PO QD for 1 week (wash-out phase) --\\> clopidogrel 75 mg plus pantoprazole 40mg PO QD for 1 week --\\> clopidogrel 75 mg PO QD for 1 week (wash-out phase) --\\> clopidogrel 75 mg plus esomeprazole 40mg PO QD for 1 week --\\>\n\n1 week washout --\\> aspirin 100mg PO QD for 1 week', 'armGroupLabels': ['Clopidogrel and proton pump inhibitors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Fu-Tien Chiang, MD, PhD', 'role': 'CONTACT', 'email': 'futienc@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '62150'}, {'name': 'Jen-Kuang Lee, MD', 'role': 'CONTACT', 'email': 'jenkuang_lee@yahoo.com.tw', 'phone': '886-2-23123456', 'phoneExt': '62394'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Fu-Tien Chiang, MD, PhD', 'role': 'CONTACT', 'email': 'futienc@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '62150'}, {'name': 'Jen-Kuang Lee, MD', 'role': 'CONTACT', 'email': 'jenkuang_lee@yahoo.com.tw', 'phone': '886-2-23123456', 'phoneExt': '62394'}], 'overallOfficials': [{'name': 'Fu-Tien Chiang, MD, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Haemonetics Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Chiang Fu-Tien, PhD', 'oldOrganization': 'National Taiwan University Hospital'}}}}