Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT01361620
Status:
COMPLETED
Last Update Posted:
2013-12-16
First Post:
2011-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Genotypic and Phenotypic Correlates of Resistance to Aspirin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mcc@email.gwu.edu', 'phone': '(202) 994-8919', 'title': 'Dr. Timothy McCaffrey', 'organization': 'George Washington University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Aspirin', 'description': 'All subjects took 7-10 days of 81 mg aspirin', 'otherNumAtRisk': 132, 'otherNumAffected': 0, 'seriousNumAtRisk': 132, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Whole Blood Coagulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aspirin', 'description': 'All subjects took 7-10 days of 81 mg aspirin'}], 'classes': [{'categories': [{'measurements': [{'value': '453.8', 'spread': '51.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single measurement at 7-10 days after beginning aspirin', 'description': 'Whole blood coagulation after stimulation with arachidonic acid, as measured in the VerifyNow Aspirin system (Accumetrics). Aspirin response units (ARU) are the residual coagulation present in patients taking aspirin. The higher the ARU, the greater residual coagulation (resistance) to the aspirin effect.', 'unitOfMeasure': 'Aspirin response units (ARU)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aspirin', 'description': 'All subjects took 7-10 days of 81 mg aspirin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from patients of the GWU Medical Faculty Associates, and physicians, faculty and staff on the GWU campus. Initially we were looking for those already prescribed to take aspirin at 81 mg daily, but due to slow recruitment, this was amended to anyone willing to take aspirin at 81 mg daily for 7-10 days', 'preAssignmentDetails': 'Excluded were 58 subjects prescribed more than 81 mg of aspirin, had known GI bleeding attributed to aspirin, active peptic ulcer disease, aspirin allergy, current use of other anti-platelet, anti-thrombotic or other therapy that has these properties, women who are pregnant, planning pregnancy or nursing. Exclusions were for safety reasons.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Aspirin', 'description': 'All subjects took 7-10 days of 81 mg aspirin'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '91', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'spread': '10.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '80', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '132', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-29', 'studyFirstSubmitDate': '2011-05-25', 'resultsFirstSubmitDate': '2013-08-19', 'studyFirstSubmitQcDate': '2011-05-26', 'lastUpdatePostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-29', 'studyFirstPostDateStruct': {'date': '2011-05-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole Blood Coagulation', 'timeFrame': 'Single measurement at 7-10 days after beginning aspirin', 'description': 'Whole blood coagulation after stimulation with arachidonic acid, as measured in the VerifyNow Aspirin system (Accumetrics). Aspirin response units (ARU) are the residual coagulation present in patients taking aspirin. The higher the ARU, the greater residual coagulation (resistance) to the aspirin effect.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['genomic markers', 'aspirin resistance'], 'conditions': ['Platelet Dysfunction Due to Aspirin']}, 'referencesModule': {'references': [{'pmid': '23454623', 'type': 'RESULT', 'citation': 'Fallahi P, Katz R, Toma I, Li R, Reiner J, VanHouten K, Carpio L, Marshall L, Lian Y, Bupp S, Fu SW, Rickles F, Leitenberg D, Lai Y, Weksler BB, Rebling F, Yang Z, McCaffrey TA. Aspirin insensitive thrombophilia: transcript profiling of blood identifies platelet abnormalities and HLA restriction. Gene. 2013 May 15;520(2):131-8. doi: 10.1016/j.gene.2013.02.032. Epub 2013 Feb 27.'}]}, 'descriptionModule': {'briefSummary': 'The study seeks to identify genomic markers associated with aspirin resistance.', 'detailedDescription': 'Not desired'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteers 40 to 80 years old willing to sign consent and take 81 mg of aspirin for 7 - 10 days and return for laboratory testing.\n\nExclusion Criteria:\n\n* Patient requiring more than 81 mg aspirin daily\n* Known GI bleeding attributed to ASA\n* Active peptic ulcer disease or history within the last year\n* Known aspirin allergy\n* Current use of:\n\n * warfarin,\n * heparin,\n * NSAIDs (except aspirin),\n * clopidogrel,\n * dipyridamole,\n * fish-oil/omega 3 supplements,\n* Women of childbearing potential who are pregnant, planning to become pregnant or nursing.'}, 'identificationModule': {'nctId': 'NCT01361620', 'acronym': 'ARSENAL', 'briefTitle': 'Genotypic and Phenotypic Correlates of Resistance to Aspirin', 'organization': {'class': 'OTHER', 'fullName': 'George Washington University'}, 'officialTitle': 'Genotypic and Phenotypic Correlates of Resistance to Anti-platelet Actions of Aspirin in an At-risk Patient Population and in the General Population', 'orgStudyIdInfo': {'id': 'AR2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Aspirin', 'description': 'All subjects took 7-10 days of 81 mg aspirin', 'interventionNames': ['Drug: aspirin']}], 'interventions': [{'name': 'aspirin', 'type': 'DRUG', 'description': 'aspirin 81mg, 7-10 days', 'armGroupLabels': ['Aspirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'GWU Medical Faculty Associates', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Jonathan Reiner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GWU Medical Faculty'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Washington University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}