Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-25 @ 12:03 PM
Study NCT ID:
NCT00349661
Status:
COMPLETED
Last Update Posted:
2008-08-25
First Post:
2006-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence Of Omeprazole On The Anti-Platelet Action Of Clopidogrel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-08-22', 'studyFirstSubmitDate': '2006-07-06', 'studyFirstSubmitQcDate': '2006-07-06', 'lastUpdatePostDateStruct': {'date': '2008-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'inter group comparison of VASP test'}]}, 'conditionsModule': {'keywords': ['clopidogrel', 'omeprazole'], 'conditions': ['Coronary Heart Disease']}, 'referencesModule': {'references': [{'pmid': '18206732', 'type': 'DERIVED', 'citation': 'Gilard M, Arnaud B, Cornily JC, Le Gal G, Lacut K, Le Calvez G, Mansourati J, Mottier D, Abgrall JF, Boschat J. Influence of omeprazole on the antiplatelet action of clopidogrel associated with aspirin: the randomized, double-blind OCLA (Omeprazole CLopidogrel Aspirin) study. J Am Coll Cardiol. 2008 Jan 22;51(3):256-60. doi: 10.1016/j.jacc.2007.06.064.'}]}, 'descriptionModule': {'briefSummary': "Objectives: A prospective investigation of the effect of omeprazole, a proton pump inhibitor, on the anti-platelet action of clopidogrel.\n\nThe main decision criterion will concern change in VASP protein phosphorylation under treatment. Phosphorylation will be measured before and after administration of omeprazole versus placebo in patients undergoing clopidogrel treatment.\n\nType of study: Single center, double blind, randomized parallel group study versus placebo, comparing two treatment groups:\n\n* clopidogrel + omeprazole + standard regime (beta-blockers, atorvastatin, IEC, aspirin)\n* clopidogrel + placebo+ standard regime (beta-blockers, atorvastatin, IEC, aspirin)\n\nStudy population: 120 patients from the Cardiology Department of Brest University hospital, Brest (France), receiving a standard treatment comprising a loading dose of clopidogrel followed by a daily dose of 75 mg associated to 75 mg aspirin, will be randomized between 20 mg/day omeprazole and 20 mg/day placebo treatment groups. The efficacy of clopidogrel will be assessed by inter-group comparison on the VASP test.\n\nStudy period: 7 days' treatment per patient. Total study period estimated at 6 months.\n\nExpected findings: The results should confirm the suspected negative effect of omeprazole on clopidogrel's impact on arterial thrombosis risk, secondarily allowing new recommendations to be drawn up for this association.", 'detailedDescription': "Preventing recurrence of thrombosis following angioplasty relies on dual-therapy associating the anti-platelet agents aspirin and clopidogrel. This regime is kept up for between 1 and 6 months, depending on the type of stent deployed in the angioplasty. The biological effectiveness of the clopidogrel treatment can be assessed by the VASP test, a new platelet test, results on which have been shown to correlate with risk of thrombosis. A study we ran recently strongly suggested that omeprazole was associated with a poor response to clopidogrel. Omeprazole is an anti-ulcer agent frequently prescribed to prevent unwanted side-effects of aspirin, making it frequently associated to clopidogrel in the aftermath of angioplasty.\n\nStudy population: 120 patients from the Cardiology Department of Brest University hospital, Brest (France), receiving a standard treatment comprising a loading dose of clopidogrel followed by a daily dose of 75 mg associated to 75 mg aspirin, will be randomized between 20 mg/day omeprazole and 20 mg/day placebo treatment groups. The efficacy of clopidogrel will be assessed by inter-group comparison on the VASP test.\n\nStudy period: 7 days' treatment per patient. Total study period estimated at 6 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with indication of aspirin and clopidogrel treatment\n\nExclusion Criteria:\n\n* patient\\<18 years\n* liver disease\n* drug eluting stent\n* gastrointestinal ulcus\n* bleeding\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT00349661', 'briefTitle': 'Influence Of Omeprazole On The Anti-Platelet Action Of Clopidogrel', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Influence Of Omeprazole On The Anti-Platelet Action Of Clopidogrel Associated To Aspirin: Double-Blind Randomized Trial Against Placebo', 'orgStudyIdInfo': {'id': 'OCLA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'impact on VASP test', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'Department of Cardiology', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'overallOfficials': [{'name': 'martine gilard, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}}}}