Influence Of Omeprazole On The Anti-Platelet Action Of Clopidogrel
University Hospital, Brest
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
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.
Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.