Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-27 @ 8:19 AM
Study NCT ID:
NCT01307657
Status:
COMPLETED
Last Update Posted:
2023-09-01
First Post:
2011-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of a High-fat Meal on Assessment of Clopidogrel-induced Platelet Inhibition in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2012-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2011-02-22', 'studyFirstSubmitQcDate': '2011-03-01', 'lastUpdatePostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Platelet inhibition', 'timeFrame': '3 time points over 6 hours', 'description': 'platelet inhibition before versus after a high-fat meal (measured by light transmission aggregometry, whole blood aggregometry, flow cytometry, and VerifyNow assay)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['clopidogrel', 'platelet', 'platelet function test', 'healthy', 'Platelet function tests'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '25642145', 'type': 'DERIVED', 'citation': 'Dobesh PP, Urban JF, Shurmur SW, Oestreich JH. Impact of a high-fat meal on assessment of clopidogrel-induced platelet inhibition in healthy subjects. Thromb J. 2015 Jan 23;13(1):3. doi: 10.1186/s12959-014-0033-x. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a high-fat meal affects the ability of platelet function tests to measure platelet inhibition by clopidogrel.', 'detailedDescription': 'The purpose of this study is to determine the influence of a high-fat meal on assessment of clopidogrel-induced platelet inhibition in healthy people using platelet function assays. Twelve healthy adult subjects will be recruited to take part in this research study. After consent is obtained, subjects will be asked to present to the clinical research center after a 12 hour fast. A baseline blood sample will be drawn at 8 am, and subjects will then be administered a 600 mg dose of clopidogrel. At 12 noon, another blood sample will be drawn to evaluate the extent of maximum platelet inhibition in the fasting state. Subjects will then be provided a standardized high-fat meal with an additional blood sample at 2 pm to evaluate the impact of the high-fat on platelet function assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19 years of age or older\n* healthy subjects\n* deny taking medications that affect platelet function for at least 7 days prior to test\n\nExclusion Criteria:\n\n* history of cardiovascular disease\n* any risk factors for cardiovascular disease\n* surgery in last 3 months\n* history of anemia/thrombocytopenia\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01307657', 'briefTitle': 'Impact of a High-fat Meal on Assessment of Clopidogrel-induced Platelet Inhibition in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Impact of a High-fat Meal on Assessment of Clopidogrel-induced Platelet Inhibition in Healthy Subjects', 'orgStudyIdInfo': {'id': '0568-10-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Clopidogrel impact on platelet function', 'description': 'Participants will have a baseline blood sample drawn after a 12 hour fast at 8 am, then be administered a 600 mg dose of clopidogrel. At noon, another blood sample will be drawn to evaluate the extent of maximum platelet inhibition in the fasting state. Participants will then be provided a standardized high-fat meal, then an additional blood sample at 2 pm to evaluate the impact of the high-fat on platelet function assessment.', 'interventionNames': ['Other: high fat meal']}], 'interventions': [{'name': 'high fat meal', 'type': 'OTHER', 'description': 'Clopidogrel 600 mg loading dose at 8 am and high-fat meal at 12 pm', 'armGroupLabels': ['Clopidogrel impact on platelet function']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Julie Oestreich, PharmD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}