NCT00349661

Influence Of Omeprazole On The Anti-Platelet Action Of Clopidogrel Associated To Aspirin: Double-Blind Randomized Trial Against Placebo

Completed Phase 3 Last updated 22 August 2008

What this trial tests

Phase 3 trial testing impact on VASP test in Coronary Heart Disease in 120 participants. Completed in 1 December 2006.

Timeline

1 June 2006

1 December 2006

Quick facts

Lead sponsor	University Hospital, Brest
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	120
Start date	1 June 2006
Estimated completion	1 December 2006
Sites	1 location across France

Drugs / interventions tested

• impact on VASP test — full drug profile →

Conditions studied

• Coronary Heart Disease — all drugs for Coronary Heart Disease →

Sponsor

University Hospital, Brest

Who can join

Adults 18 to 85, any sex, with Coronary Heart Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• inter group comparison of VASP test

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.