Healthy
Conditions
Keywords
celecoxib, platelet, thrombosis, Volunteers
Brief 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.
Interventions
DRUGaspirin
aspirin 100 mg qd for 7 days
DRUGcelecoxib
celecoxib 200 mg bid \* 7 days
DRUGaspirin + celecoxib
aspirin 100 mg qd + celecoxib 200 mg bid for 7 days
asprin 100 mg qd + clopidogrel 75 mg qd for 7 days
DRUGaspirin + clopidogrel + celecoxib
aspirin 100 mg qd + clopidogrel 75 mg qd + celecoxib 200 mg bid
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy volunteers including both men and women 20\ 30 years * no abnormality in physical examination, 12-lead ECG, and routine laboratory test
Exclusion criteria
* Subjects with cardiovascular disease, hemostatic disorder, hypersensitivity to NSAIDs and clopidogrel * Women with a positive pregnancy test * smoker * chronic drinkers * overweight exceeding 20% of standard body weight
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Light transmittance aggregometry : % of inhibition (ADP, collagen) | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Urine arachidonic metabolite assay | 7 days |
Countries
South Korea
Outcome results
None listed