Influence Of Omeprazole On The Anti-Platelet Action Of Clopidogrel
1 other identifier
interventional
120
1 country
1
Brief Summary
Objectives: A prospective investigation of the effect of omeprazole, a proton pump inhibitor, on the anti-platelet action of clopidogrel. The 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. Type of study: Single center, double blind, randomized parallel group study versus placebo, comparing two treatment groups:
- clopidogrel + omeprazole + standard regime (beta-blockers, atorvastatin, IEC, aspirin)
- clopidogrel + placebo+ standard regime (beta-blockers, atorvastatin, IEC, aspirin) Study 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. Study period: 7 days' treatment per patient. Total study period estimated at 6 months. Expected 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2006
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 6, 2006
CompletedFirst Posted
Study publicly available on registry
July 7, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedAugust 25, 2008
August 1, 2008
July 6, 2006
August 22, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
inter group comparison of VASP test
Interventions
Eligibility Criteria
You may qualify if:
- patient with indication of aspirin and clopidogrel treatment
You may not qualify if:
- patient\<18 years
- liver disease
- drug eluting stent
- gastrointestinal ulcus
- bleeding
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Cardiology
Brest, 29200, France
Related Publications (1)
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.
PMID: 18206732DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
martine gilard, md
PI
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 6, 2006
First Posted
July 7, 2006
Study Start
June 1, 2006
Study Completion
December 1, 2006
Last Updated
August 25, 2008
Record last verified: 2008-08