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

Study Overview
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Brief Summary
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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.

Official Title
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Phase 4 Study of the Effect of Celecoxib on the Antiplatelet Effect of Aspirin and Clopidogrel

Conditions
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Healthy

Intervention / Treatment
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* Drug: aspirin
* Drug: celecoxib
* Drug: aspirin + celecoxib
* Drug: aspirin + clopidogrel
* Drug: aspirin + clopidogrel + celecoxib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ASA<br>aspirin only | Drug: aspirin<br>* aspirin 100 mg qd for 7 days<br>* Other names: celecoxib : Pfizer;|
| Active Comparator: Cele<br> | Drug: celecoxib<br>* celecoxib 200 mg bid * 7 days<br>* Other names: celecoxib : Pfizer;|
| Experimental: ASA + Cele<br> | Drug: aspirin + celecoxib<br>* aspirin 100 mg qd + celecoxib 200 mg bid for 7 days<br>* Other names: celecoxib : Pfizer;|
| Active Comparator: ASA + Clo<br> | Drug: aspirin + clopidogrel<br>* asprin 100 mg qd + clopidogrel 75 mg qd for 7 days<br>* Other names: celecoxib : Pfizer;|
| Experimental: ASA + Clo + Cele<br> | Drug: aspirin + clopidogrel + celecoxib<br>* aspirin 100 mg qd + clopidogrel 75 mg qd + celecoxib 200 mg bid<br>* Other names: celecoxib : Pfizer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Light transmittance aggregometry : % of inhibition (ADP, collagen) |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine arachidonic metabolite assay |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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celecoxib, platelet, thrombosis, Volunteers