Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2025-12-27 @ 9:53 PM
Study NCT ID:
NCT01843361
Status:
COMPLETED
Last Update Posted:
2013-04-30
First Post:
2013-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clopidogrel Response in Acute Ischemic Stroke. The Bochumer CRISP Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-26', 'studyFirstSubmitDate': '2013-04-26', 'studyFirstSubmitQcDate': '2013-04-26', 'lastUpdatePostDateStruct': {'date': '2013-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Result of platelet function test', 'timeFrame': 'one day', 'description': 'Aggregometry result of antiplatelet therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stroke', 'Clopidogrel', 'Aggregometry', 'Antiplatelet therapy', 'Platelet function tests'], 'conditions': ['Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '22159509', 'type': 'BACKGROUND', 'citation': 'Meves SH, Overbeck U, Endres HG, Krogias C, Neubauer H. Dose-dependent effect of early antiplatelet therapy in acute ischaemic stroke. Thromb Haemost. 2012 Jan;107(1):69-79. doi: 10.1160/TH11-06-0436. Epub 2011 Dec 8.'}, {'pmid': '20621513', 'type': 'BACKGROUND', 'citation': 'Fong J, Cheng-Ching E, Hussain MS, Katzan I, Gupta R. Predictors of biochemical aspirin and clopidogrel resistance in patients with ischemic stroke. J Stroke Cerebrovasc Dis. 2011 May-Jun;20(3):227-30. doi: 10.1016/j.jstrokecerebrovasdis.2009.12.004. Epub 2010 Jul 10.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to determine the prevalence rate and risk factors for chemical laboratory clopidogrel low-response (CLR) in the acute phase after an ischemic stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with an acute ischemic stroke admitted to our stroke unit and treated with clopidogrel', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute ischemic stroke\n* admittance to stroke unit\n* clopidogrel medication\n\nExclusion Criteria:\n\n* no consent\n* prior bleeding disorders\n* severe liver disorders\n* current gastrointestinal disorders\n* congestive heart failure\n* life-threatening malignancies'}, 'identificationModule': {'nctId': 'NCT01843361', 'acronym': 'Bo-CRISP', 'briefTitle': 'Clopidogrel Response in Acute Ischemic Stroke. The Bochumer CRISP Study', 'organization': {'class': 'OTHER', 'fullName': 'Ruhr University of Bochum'}, 'officialTitle': 'Prevalence of Low Response to Clopidogrel in Patients After Acute Ischemic Stroke.', 'orgStudyIdInfo': {'id': 'Meves-clopi-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'acute ischemic stroke', 'description': 'Determing cardiovascular risk factors or medication on clopidogrel response rates after an acute ischemic stroke'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Department of Neurology, Ruhr University Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}], 'overallOfficials': [{'name': 'Saskia H Meves, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruhr University Bochum, Department of Neurology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruhr University of Bochum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Saskia Meves', 'investigatorAffiliation': 'Ruhr University of Bochum'}}}}