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Influence Of Omeprazole On The Anti-Platelet Action Of Clopidogrel
This study has been completed.
Study NCT00349661   Information provided by University Hospital, Brest
First Received: July 6, 2006   Last Updated: August 22, 2008   History of Changes

July 6, 2006
August 22, 2008
June 2006
inter group comparison of VASP test
inter group comparaison of VASP test
Complete list of historical versions of study NCT00349661 on ClinicalTrials.gov Archive Site
 
 
 
Influence Of Omeprazole On The Anti-Platelet Action Of Clopidogrel
Influence Of Omeprazole On The Anti-Platelet Action Of Clopidogrel Associated To Aspirin: Double-Blind Randomized Trial Against Placebo

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.

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.

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.

Phase III
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacokinetics Study
Coronary Heart Disease
Drug: impact on VASP test
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
120
December 2006
 

Inclusion Criteria:

  • patient with indication of aspirin and clopidogrel treatment

Exclusion Criteria:

  • patient<18 years
  • liver disease
  • drug eluting stent
  • gastrointestinal ulcus
  • bleeding
  • pregnancy
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00349661
 
OCLA
University Hospital, Brest
 
Principal Investigator: martine gilard, md PI
University Hospital, Brest
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP