Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-01-11 @ 5:35 PM
Study NCT ID:
NCT03190005
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2017-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Downstream Molecular Signals of P2Y12 Receptors in Hyporeactive Patients Under Clopidogrel Treatment A Possible Mechanism of HOTPR(High On-Treatment Platelet Reactivity)
Sponsor:
Organization:
Raw JSON
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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': 'chenyuehchung.tw@yahoo.com.tw', 'phone': '88627093600', 'title': 'chen yueh-chung', 'phoneExt': '3741', 'organization': 'taipei city hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'major/minor drug reaction', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'placebo control without medication.\n\nPlacebos: no medication, healthy subjects.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2', 'description': 'hyper-reactive responser after clopidogrel.\n\nclopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 3', 'description': 'hypo-reactive responser after clopidogrel.\n\nclopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Group 4', 'description': 'normo-reactive responser after clopidogrel.\n\nclopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 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{'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}, {'units': 'blood sample', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'placebo control without medication.\n\nPlacebos: no medication, healthy subjects.'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'hyper-reactive responser after clopidogrel.\n\nclopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'hypo-reactive responser after clopidogrel.\n\nclopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)'}, {'id': 'OG003', 'title': 'Group 4', 'description': 'normo-reactive responser after clopidogrel.\n\nclopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)'}, {'id': 'OG004', 'title': 'Group 5', 'description': 'reaction after OPC-13013\n\nclopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)'}, {'id': 'OG005', 'title': 'Group 6', 'description': 'reaction after AR-C\n\nclopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)'}, {'id': 'OG006', 'title': 'Group 7', 'description': 'reaction after simastatin\n\nclopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)'}], 'classes': [{'categories': [{'measurements': [{'value': '148', 'spread': '3', 'groupId': 'OG000'}, 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[{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '35', 'groupId': 'BG007'}]}, {'units': 'blood samples', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '35', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'placebo control without medication.\n\nPlacebos: no medication, healthy subjects.'}, {'id': 'BG001', 'title': 'Group 2', 'description': 'hyper-reactive responser after clopidogrel.\n\nclopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)'}, {'id': 'BG002', 'title': 'Group 3', 'description': 'hypo-reactive responser after clopidogrel.\n\nclopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)'}, {'id': 'BG003', 'title': 'Group 4', 'description': 'normo-reactive responser after clopidogrel.\n\nclopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)'}, {'id': 'BG004', 'title': 'Group 5', 'description': 'reaction after OPC-13013'}, {'id': 'BG005', 'title': 'Group 6', 'description': 'reaction after AR-C'}, {'id': 'BG006', 'title': 'Group 7', 'description': 'reaction after simastatin'}, {'id': 'BG007', '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': 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Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.52', 'spread': '11.12', 'groupId': 'BG000'}, {'value': '64.92', 'spread': '13.24', 'groupId': 'BG001'}, {'value': '66.89', 'spread': '10.72', 'groupId': 'BG002'}, {'value': '63.35', 'spread': '13.62', 'groupId': 'BG003'}, {'value': '65.09', 'spread': '11.13', 'groupId': 'BG004'}, {'value': '61.23', 'spread': '10.34', 'groupId': 'BG005'}, {'value': '68.32', 'spread': '15.12', 'groupId': 'BG006'}, {'value': '67.36', 'spread': '13.82', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 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'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'blood samples', 'populationDescription': 'patient receive different anti-platelet drug(in vivo or in vitro)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-22', 'size': 338581, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-08T06:01', 'hasProtocol': False}, {'date': '2017-06-06', 'size': 650690, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-10-08T06:08', 'hasProtocol': False}, {'date': '2017-06-06', 'size': 335815, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-08T19:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'downstream molecular signals of P2Y12 receptor in the platelet(Platelet Rich Plasma).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-02', 'studyFirstSubmitDate': '2017-06-06', 'resultsFirstSubmitDate': '2018-02-22', 'studyFirstSubmitQcDate': '2017-06-15', 'lastUpdatePostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-02', 'studyFirstPostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PRU(Platelet Rreactivity Unit) 24 Hours After DAPT(Dual AntiPlatelet Therapy) Western Blot After Medication', 'timeFrame': '24 hours', 'description': 'PRU(Platelet Rreactivity Unit) 24 hours after DAPT(Dual AntiPlatelet Therapy) Western blot after medication'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PRU', 'P2Y12 receptor'], 'conditions': ['Stable Angina']}, 'descriptionModule': {'briefSummary': 'The investigators designed the following experiment to observe the pattern of administration in vitro, which can be completely excluded liver enzyme cytochrome P450 metabolism under the influence and observe the relevant P2Y12 receptor downstream signal changes, hope in the above experiments, that the human body directly for the difference between the existence of drug reactions exist.', 'detailedDescription': 'Platelet reactivity has been accepted as an indicator of the reaction of the P2Y12 inhibitor during treatment, currently, the existing evidence to support the post-treatment platelet activity can be used to distinguish the potential risk among patients who received percutaneous transluminal coronary angioplasty after ischemic / thrombotic events. The risks of stent thrombosis, of which, by analysis of the PRU (P2Y12 reaction units) value level of VerifyNow System has been considered an international standard tools. PRU value by VerifyNow system can easily and quickly showed platelet reactivity relative to short or long term risk stratification under dual antiplatelet agents(aspirin and clopidogrel) after stents implantation. High PRU response units (drug poor responders) in accordance with the 2013 publication of the European Society of Cardiology guidelines defined of platelet function, is PRU not less than 208(≥208).\n\nThe investigators ran a previous related plan within 2014 under the medical study project budget of the Taipei City hospital, which named "platelet reactivity as a post-percutaneous coronary stent implantation antiplatelet adjust the reference", it has been figured that responsibility under the P2Y12 receptor inhibitors were significantly different between the taiwanese and Caucasians (taiwanese revealed clopidogrel lower responsive, but stronger reaction to ticagrelor), although "low" response to clopidogrel between taiwanese (In fact, according to our experiments, 30 days after medication, the rate of HOTPR-High On- Treatment Platelet Reactivity; namely PRU≥208, the taiwanese and Caucasians are very close to each), but it has relative lower subacute stent thrombosis rate than the Caucasian at 30 days(This reaction is also known as the "Asian paradox" ), according to literature known abroad because of the high prevalence of CYP2C19 point gene deletion rate among the Asians (compare with Caucasians: \\~ 65% vs \\~ 30%); there also suggested other possible explanations: Caucasian factor V Leiden (G1691A) and prothrombin (G20210A) a higher proportion of mutations, on hemostatic factors (fibrinogen, d-dimer, and factor VIII) and plasma endothelial activation markers (such as von Willebrand factor, intercellular adhesion molecule 1, and E-selectin) existed differences between the races; in addition, a number of different indicators of inflammation, such as CRP. Asians show lower level CRP than the Caucasians. However, did the investigators found the true answer? So, the investigators designed the following experiment, through the mode of drug administration in vitro, can completely exclude the influence of the liver metabolic enzyme cytochrome P450, and observe the relevant downstream signals of P2Y12 receptors. The investigators believed through the current study, the internal differences in drug responsibility can be clarified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'stable angina who received routine dual antiplatelet agents therapy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DAPT(Dual antiplatelet therapy) after regular stent implantation.\n\nExclusion Criteria:\n\n* allergy to DAPT(Dual antiplatelet therapy). major bleeding intolerance to DAPT(Dual antiplatelet therapy).'}, 'identificationModule': {'nctId': 'NCT03190005', 'briefTitle': 'Downstream Molecular Signals of P2Y12 Receptors in Hyporeactive Patients Under Clopidogrel Treatment A Possible Mechanism of HOTPR(High On-Treatment Platelet Reactivity)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei City Hospital'}, 'officialTitle': 'Downstream Molecular Signals of P2Y12 Receptors in Hyporeactive Patients Under Clopidogrel Treatment (A Possible Mechanism of HOTPR:High On- Treatment Platelet Reactivity)', 'orgStudyIdInfo': {'id': 'TCHIRB-10603117-E'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group 1', 'description': 'placebo control without medication.', 'interventionNames': ['Drug: Placebos']}, {'label': 'group 2', 'description': 'hyper-reactive responser after clopidogrel.', 'interventionNames': ['Drug: clopidogrel']}, {'label': 'group 3', 'description': 'hypo-reactive responser after clopidogrel.', 'interventionNames': ['Drug: clopidogrel']}, {'label': 'group 4', 'description': 'normo-reactive responser after clopidogrel.', 'interventionNames': ['Drug: clopidogrel']}, {'label': 'group 5', 'description': 'reaction after OPC-13013', 'interventionNames': ['Drug: clopidogrel']}, {'label': 'group 6', 'description': 'reaction after AR-C', 'interventionNames': ['Drug: clopidogrel']}, {'label': 'group 7', 'description': 'reaction after simastatin', 'interventionNames': ['Drug: clopidogrel']}], 'interventions': [{'name': 'clopidogrel', 'type': 'DRUG', 'description': 'routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)', 'armGroupLabels': ['group 2', 'group 3', 'group 4', 'group 5', 'group 6', 'group 7']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'no medication, healthy subjects.', 'armGroupLabels': ['group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei city hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yueh-Chung, Chen', 'investigatorAffiliation': 'Taipei City Hospital'}}}}