Influence Of Omeprazole On The Anti-Platelet Action Of Clopidogrel
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| ClinicalTrials.gov Identifier: NCT00349661 |
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Recruitment Status
:
Completed
First Posted
: July 7, 2006
Last Update Posted
: August 25, 2008
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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 |
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 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 |
- inter group comparison of VASP test
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patient with indication of aspirin and clopidogrel treatment
Exclusion Criteria:
- patient<18 years
- liver disease
- drug eluting stent
- gastrointestinal ulcus
- bleeding
- pregnancy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349661
| France | |
| Department of Cardiology | |
| Brest, France, 29200 | |
| Principal Investigator: | martine gilard, md | PI |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00349661 History of Changes |
| Other Study ID Numbers: |
OCLA |
| First Posted: | July 7, 2006 Key Record Dates |
| Last Update Posted: | August 25, 2008 |
| Last Verified: | August 2008 |
Keywords provided by University Hospital, Brest:
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clopidogrel omeprazole |
Additional relevant MeSH terms:
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Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Clopidogrel Omeprazole 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 |