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Phase 4 Study of the Effect of Celecoxib on the Antiplatelet Effect of Aspirin and Clopidogrel
Background: * The prevalence of arthritis which needs celecoxib prescription is high in patients with coronary artery disease. * The main concern is that celecoxib would increase thrombogenicity by inhibiting the synthesis of prostacyclin in endothelial cells. * It is not known whether the administration of celecoxib would deteriorate antiplatelet effects of aspirin and clopidogrel which are used after stenting. Methods: * Healthy volunteers (n=40) * Randomization into five subgroups * aspirin, celecoxib, aspirin+celecoxib, aspirin+clopidogrel, aspirin+clopidogrel+celecoxib * Medication schedule : medication of each drug for 6 days, blood samples at day 0 and day 7 * Celecoxib 200mg twice a day, and/or aspirin 100mg daily, and/or clopidogrel 75 mg daily * Platelet function test : light transmittance aggregometry and arachidonic acid metabolite assay among subgroups. Study hypothesis : The addition of celecoxib does not deteriorate antiplatelet function of aspirin and clopidogrel.
Details
| Lead sponsor | Seoul National University Hospital |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 40 |
| Start date | 2005-03 |
| Completion | 2005-06 |
Conditions
- Healthy
Interventions
- aspirin
- celecoxib
- aspirin + celecoxib
- aspirin + clopidogrel
- aspirin + clopidogrel + celecoxib
Primary outcomes
- Light transmittance aggregometry : % of inhibition (ADP, collagen) — 7 days
Countries
South Korea