Influence Of Omeprazole On The Anti-Platelet Action Of Clopidogrel
Completed
University Hospital, Brest
Phase 3
2006-06-01
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.
To Compare the Gastroprotective Effects and Pharmacokinetic Profile of PA Versus Enteric-Coated Aspirin
Completed
POZEN
Phase 1
2006-11-01
Primary: To compare the gastroprotective effects of a once-daily dose of PA 325 combination
tablet combining 325 mg pH sensitive aspirin and 20 mg immediate release omeprazole versus a
once-daily dose of 325 mg enteric coated aspirin utilizing Lanza scores from endoscopy
findings in normal healthy volunteers.
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