Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-01-06 @ 7:22 AM
Study NCT ID:
NCT03806894
Status:
UNKNOWN
Last Update Posted:
2019-07-10
First Post:
2019-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clopidogrel Resistance in Stroke Patients From Different Ethnicities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-09', 'studyFirstSubmitDate': '2019-01-15', 'studyFirstSubmitQcDate': '2019-01-15', 'lastUpdatePostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of clopidogrel resistance assessed among the different ethnicities', 'timeFrame': '6 months'}, {'measure': 'Identifying of high-risk subgroups of adverse clinical outcomes', 'timeFrame': '6 to 12 months'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clopidogrel, Poor Metabolism of', 'Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'Clopidogrel is an anti-platelet agent used to inhibit blood clots. Variation in response to clopidogrel has been reported among different population and may lead to reoccurring ischemic events. The aim of the present study is to evaluate the incidence of clopidogrel resistance in ischemic stroke patients from different ethnicities in Northern Israel and to find different strategies to overcome high platelet reactivity including clopidogrel dose adjustment or the choice of alternative agents. Quantification of platelet aggregation will be determined by vasodilator stimulated phosphoprotein (VASP) assay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This prospective study will be conducted in two sites (Ziv Medical Center, Safed, department of neurology, and Galilee Medical Center, Nahariya, department of neurology) on 300 patients from different ethnic backgrounds with an ischemic cerebrovascular event (ischemic stroke and TIA), treated with clopidrogel for secondary stroke prevention. The groups will consist of Jewish communities (Ashkenazi, Sephardi and Ethiopian) and Arab populations (Muslim, Christian and Druze).\n\nTo be considered eligible to participate in this study, patients have to be able to provide signed and dated written informed consent or written assent from their relatives. Both genders aged 18 and above are eligible for this trial. Pregnant patients will be excluded.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability to provide written informed consent and to be compliant with protocol assessments.\n2. Ages 18 and above inclusive\n3. Both genders eligible for the study\n4. Diagnosis of ischemic cerebrovascular event\n\nExclusion Criteria:\n\n1. Pregnant patients will be excluded\n2. Ages below 18\n3. Patients not able to provide informed consent'}, 'identificationModule': {'nctId': 'NCT03806894', 'briefTitle': 'Clopidogrel Resistance in Stroke Patients From Different Ethnicities', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ziv Hospital'}, 'officialTitle': 'Prospective Study Evaluating Clopidogrel Resistance in Ischemic Stroke Patients From Different Ethnicities', 'orgStudyIdInfo': {'id': '0112-17-ZIV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Jewish communities', 'description': 'Ashkenazi, Sephardi, Ethiopian', 'interventionNames': ['Diagnostic Test: Quantification of platelet aggregation']}, {'label': 'Arab populations', 'description': 'Muslim, Christian, Druze', 'interventionNames': ['Diagnostic Test: Quantification of platelet aggregation']}], 'interventions': [{'name': 'Quantification of platelet aggregation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Platelet aggregation will be determined by vasodilator-stimulated phosphoprotein (VASP) assay', 'armGroupLabels': ['Arab populations', 'Jewish communities']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziv Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Hematology Department', 'investigatorFullName': 'Dr. Najib Dally', 'investigatorAffiliation': 'Ziv Hospital'}}}}