Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-01-16 @ 8:12 PM
Study NCT ID:
NCT00992420
Status:
COMPLETED
Last Update Posted:
2022-11-23
First Post:
2009-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genotype Information and Functional Testing Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2010-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-21', 'studyFirstSubmitDate': '2009-10-05', 'studyFirstSubmitQcDate': '2009-10-08', 'lastUpdatePostDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'residual platelet reactivity', 'timeFrame': '6 months', 'description': 'Outcome 1 is residual platelet reactivity the measurement'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['thienopyridine', 'platelets', 'CYP2C19', 'clopidogrel', 'platelet function tests', 'platelet', 'genes', 'cytochrome P450', 'single nucleotide polymorphisms', 'Platelet Aggregation Inhibitors'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '22624833', 'type': 'DERIVED', 'citation': 'Price MJ, Murray SS, Angiolillo DJ, Lillie E, Smith EN, Tisch RL, Schork NJ, Teirstein PS, Topol EJ; GIFT Investigators. Influence of genetic polymorphisms on the effect of high- and standard-dose clopidogrel after percutaneous coronary intervention: the GIFT (Genotype Information and Functional Testing) study. J Am Coll Cardiol. 2012 May 29;59(22):1928-37. doi: 10.1016/j.jacc.2011.11.068.'}]}, 'descriptionModule': {'briefSummary': 'This study is a sub-study of GRAVITAS (clinicaltrials.gov identifier NCT00645918). The purpose of this study is to assess which genes influence residual platelet reactivity on standard dose clopidogrel therapy, and also to determine whether certain genes influence the incremental change in platelet reactivity with high-dose clopidogrel maintenance dosing in patients who have high residual platelet reactivity on standard dosing.', 'detailedDescription': 'AS DESCRIBED BY THE PI: This study is a sub-study of GRAVITAS (clinicaltrials.gov identifier NCT00645918). The purpose of this study is to assess which genes influence residual platelet reactivity on standard dose clopidogrel therapy, and also to determine whether certain genes influence the incremental change in platelet reactivity with high-dose clopidogrel maintenance dosing in patients who have high residual platelet reactivity on standard dosing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients meeting inclusion criteria for GRAVITAS who undergo VerifyNow blood sampling for VerifyNow P2Y12 platelet function testing and IVRS entry for GRAVITAS randomization/selection determination.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients meeting inclusion criteria for GRAVITAS who undergo VerifyNow blood sampling for VerifyNow P2Y12 platelet function testing and IVRS entry for GRAVITAS randomization/selection determination\n\nExclusion Criteria:\n\n* See GRAVITAS trial (ClinicalTrials.gov identifier: NCT00645918)'}, 'identificationModule': {'nctId': 'NCT00992420', 'acronym': 'GIFT', 'briefTitle': 'Genotype Information and Functional Testing Study', 'organization': {'class': 'OTHER', 'fullName': 'Scripps Health'}, 'officialTitle': 'GIFT: Genotype Information and Functional Testing Study', 'orgStudyIdInfo': {'id': 'P95082S'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GRAVITAS Study Arm A', 'description': '"Tailored" clopidogrel regimen - total first day dose 600-mg, then 150-mg every day for 6 months'}, {'label': 'GRAVITAS Study Arm B', 'description': '"Standard" clopidogrel regimen - a placebo loading dose (six placebo tablets) and then clopidogrel 75-mg and 1 placebo tablet every day for 6 months.'}, {'label': 'GRAVITAS Study Arm C', 'description': 'Responders: A random sample of clopidogrel responders treated with a placebo loading dose (six placebo tablets) and then the standard clopidogrel regimen of 75-mg and 1 placebo tablet every day for 6 months.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Genomic Medicine', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Matthew J Price, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scripps Clinic, La Jolla, CA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scripps Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, {'name': 'Sanofi', 'class': 'INDUSTRY'}, {'name': 'Accumetrics, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}