Influence Of Omeprazole On The Anti-Platelet Action Of Clopidogrel - Full Text View

Sponsor:	University Hospital, Brest
Information provided by:	University Hospital, Brest
ClinicalTrials.gov Identifier:	NCT00349661

Purpose

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.

Condition	Intervention	Phase
Coronary Heart Disease	Drug: impact on VASP test	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Influence Of Omeprazole On The Anti-Platelet Action Of Clopidogrel Associated To Aspirin: Double-Blind Randomized Trial Against Placebo

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

Drug Information available for: Omeprazole Omeprazole magnesium Clopidogrel Clopidogrel Bisulfate Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:

inter group comparison of VASP test

Estimated Enrollment:	120
Study Start Date:	June 2006
Study Completion Date:	December 2006

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patient with indication of aspirin and clopidogrel treatment

Exclusion Criteria:

patient<18 years
liver disease
drug eluting stent
gastrointestinal ulcus
bleeding
pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349661

Locations

France
Department of Cardiology
Brest, France, 29200

Sponsors and Collaborators

University Hospital, Brest

Investigators

Principal Investigator:

martine gilard, md

PI

More Information

No publications provided by University Hospital, Brest

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00349661 History of Changes
Other Study ID Numbers:	OCLA
Study First Received:	July 6, 2006
Last Updated:	August 22, 2008
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Brest:

clopidogrel
omeprazole

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Omeprazole
Clopidogrel
Anti-Ulcer Agents
Gastrointestinal Agents

Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Hematologic Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012