drugset / Trial / NCT00882388

The Effect of Celecoxib on the Antiplatelet Effect of Aspirin and Clopidogrel in Normal Volunteers

NCT00882388

Phase 4 Completed 40 enrolled Seoul National University Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2005-03
Primary completion
2005-06
Completion
2005-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 100 mg
Comparator Celecoxib Other / unclassified 200 mg
Comparator Clopidogrel Small molecule 75 mg

Indications

No indication recorded.