Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-01-25 @ 7:31 AM
Study NCT ID:
NCT02411903
Status:
UNKNOWN
Last Update Posted:
2015-06-16
First Post:
2015-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Dynamic Effect of Non-cytochrome P450 Isoenzyme 3A4（CYP3A4）-Metabolized and Cytochrome P450 Isoenzyme 3A4（CYP3A4）-Metabolized Statins on Clopidogrel Resistance in Patients With Cerebral Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2018-03-09', 'unreleaseDateUnknown': True}, {'releaseDate': '2018-04-28', 'unreleaseDateUnknown': True}, {'resetDate': '2018-06-01', 'releaseDate': '2018-05-02'}], 'estimatedResultsFirstSubmitDate': '2018-03-09'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002544', 'term': 'Cerebral Infarction'}], 'ancestors': [{'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'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': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-14', 'studyFirstSubmitDate': '2015-03-17', 'studyFirstSubmitQcDate': '2015-04-02', 'lastUpdatePostDateStruct': {'date': '2015-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of clopidogrel resistance', 'timeFrame': 'For nine months', 'description': 'Definition of clopidogrel resistance is the absolute change of 5 microliter adenosine diphosphate(ADP) induced PAR≤10% as compared to baseline. So, incidence of clopidogrel resistance= (PAR at monitor point - PAR at baseline) / PAR at baseline×100 %≤10 %。 Measures of PAR: PAR is measured by Light transmittance aggregometry (LTA) and according to the standard of Rev。'}]}, 'conditionsModule': {'keywords': ['Clopidogrel-drug interactions'], 'conditions': ['Cerebral Infarction', 'Clopidogrel,Poor Metabolism of (Disorder)']}, 'referencesModule': {'references': [{'pmid': '19829090', 'type': 'RESULT', 'citation': 'Sugunaraj JP, Palaniswamy C, Selvaraj DR, Chaitanya Arudra SK, Sukhija R. Clopidogrel resistance. Am J Ther. 2010 Mar-Apr;17(2):210-5. doi: 10.1097/MJT.0b013e3181bdc3e4.'}, {'pmid': '15837243', 'type': 'RESULT', 'citation': 'Nguyen TA, Diodati JG, Pharand C. Resistance to clopidogrel: a review of the evidence. J Am Coll Cardiol. 2005 Apr 19;45(8):1157-64. doi: 10.1016/j.jacc.2005.01.034.'}, {'pmid': '16386660', 'type': 'RESULT', 'citation': 'Lev EI, Patel RT, Maresh KJ, Guthikonda S, Granada J, DeLao T, Bray PF, Kleiman NS. Aspirin and clopidogrel drug response in patients undergoing percutaneous coronary intervention: the role of dual drug resistance. J Am Coll Cardiol. 2006 Jan 3;47(1):27-33. doi: 10.1016/j.jacc.2005.08.058. Epub 2005 Dec 9.'}]}, 'descriptionModule': {'briefSummary': 'The investigators team had found that the presence of dynamic changes of Clopidogrel resistance are not associated with genetic factors. Currently, study on moderate doses of statins and dynamic Clopidogrel resistance has not been reported, therefore this study will observe 160 cases of open prospective secondary prevention in patients with cerebral infarction. Excluded: those patients occurs Clopidogrel resistance because of slow metabolism caused by cytochrome P450 isoenzyme 2C19（CYP2C19, and then observed the impact of the cytochrome P450 isoenzyme 3A4 （CYP3A4）-metabolized and non-cytochrome P450 isoenzyme 3A4 （CYP3A4）-metabolized statins dynamically on Clopidogrel resistance in the next 9 months, adverse events will be recorded, the metabolite of clopidogrel（H4 ）and the polymorphism of cytochrome P450 isoenzyme 2C19 （CYP2C19）/cytochrome P450 isoenzyme 3A4 （CYP3A4）/ cytochrome P450 isoenzyme 2C9（CYP2C9）will be detected. Expected Result: the patients use the cytochrome P450 isoenzyme 3A4（CYP3A4）-metabolized statins will result in dynamic Clopidogrel resistance easily ,H4 levels will decline, and Clopidogrel resistance is not related to the polymorphism of cytochrome P450 isoenzyme 3A4 （CYP3A4）.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.\n* Age \\<85 years and \\>45 years ,Male or female.\n* The patient have been Cerebral infarction for one month.\n* national institutes of health stroke scale（NIHSS）score ≤23 points.\n* Blood Platelet count greater than 150×10\\^9／L,and Less than 500×10\\^9／L.\n* The patient never do not taking aspirin 、dipyridamole、clopidogrel,or the patient had been taken these anti-platelet drugs but has been discontinued for two weeks at least.\n* The patient never do not taking Statins or the patient have been stop taking statins 2 weeks for two weeks.\n\nExclusion Criteria:\n\n* Allergic constitution , or allergic to the composition of the drugs in this study.\n* national institutes of health stroke scale（NIHSS） score \\>23 points.\n* Atrial fibrillation and other cardiogenic cerebral embolism.\n* Patients who were undergone surgery and trauma (including fractures) within the past three month.\n* Patients with known dysfunction of vital organs or suffered from Serious cardiovascular disease ，or coagulation disorders.\n* The patient took Proton pump inhibitors recently.\n* The history of data collection and the follow-up process can not be saved.'}, 'identificationModule': {'nctId': 'NCT02411903', 'briefTitle': 'The Dynamic Effect of Non-cytochrome P450 Isoenzyme 3A4（CYP3A4）-Metabolized and Cytochrome P450 Isoenzyme 3A4（CYP3A4）-Metabolized Statins on Clopidogrel Resistance in Patients With Cerebral Infarction', 'organization': {'class': 'OTHER', 'fullName': 'The Third Affiliated Hospital of Guangzhou Medical University'}, 'orgStudyIdInfo': {'id': 'H0906'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'atorvastatin and Clopidogrel', 'description': '80 patients will be taking atorvastatin 40mg/d plus clopidogrel 75mg/d for 9 months。', 'interventionNames': ['Drug: atorvastatin and clopidogrel']}, {'type': 'EXPERIMENTAL', 'label': 'rosuvastatin and Clopidogrel', 'description': '80 patients will be taking rosuvastatin 20mg/d plus clopidogrel 75mg/d for 9 months。', 'interventionNames': ['Drug: rosuvastatin and clopidogrel']}], 'interventions': [{'name': 'atorvastatin and clopidogrel', 'type': 'DRUG', 'description': 'Dose: atorvastatin 40mg/d plus clopidogrel 75mg/d for 9 months.', 'armGroupLabels': ['atorvastatin and Clopidogrel']}, {'name': 'rosuvastatin and clopidogrel', 'type': 'DRUG', 'description': 'Dose: rosuvastatin 20mg/d plus clopidogrel 75mg/d for 9 months.', 'armGroupLabels': ['rosuvastatin and Clopidogrel']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Third Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physicians', 'investigatorFullName': 'Bo Rong Zhou', 'investigatorAffiliation': 'The Third Affiliated Hospital of Guangzhou Medical University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-03-09', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2018-04-28', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2018-05-02', 'type': 'RELEASE'}, {'date': '2018-06-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Bo Rong Zhou, chief physicians, The Third Affiliated Hospital of Guangzhou Medical University'}}}}