Influence Of Omeprazole On The Anti-Platelet Action Of Clopidogrel

• ClinicalTrials.gov Identifier: NCT00349661
• Recruitment Status: Completed
• First Posted: July 7, 2006
• Last Update Posted: August 25, 2008
• Sponsor: University Hospital, Brest
• Information provided by: University Hospital, Brest

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Coronary Heart Disease	Drug: impact on VASP test	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Influence Of Omeprazole On The Anti-Platelet Action Of Clopidogrel Associated To Aspirin: Double-Blind Randomized Trial Against Placebo
• Study Start Date: June 2006
• Actual Study Completion Date: December 2006

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. inter group comparison of VASP test

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

France

Department of Cardiology

Brest, France, 29200

Sponsors and Collaborators

University Hospital, Brest

Investigators

• Principal Investigator: martine gilard, md; PI

More Information

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. doi: 10.1016/j.jacc.2007.06.064.

• ClinicalTrials.gov Identifier: NCT00349661 History of Changes
• Other Study ID Numbers: OCLA
• First Posted: July 7, 2006
• Last Update Posted: August 25, 2008
• Last Verified: August 2008

Keywords provided by University Hospital, Brest:

clopidogrel; omeprazole

Additional relevant MeSH terms:

Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Omeprazole; Clopidogrel; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors