The Effect of Celecoxib on the Antiplatelet Effect of Aspirin and Clopidogrel in Normal Volunteers
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|ClinicalTrials.gov Identifier: NCT00882388|
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : December 17, 2013
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: aspirin Drug: celecoxib Drug: aspirin + celecoxib Drug: aspirin + clopidogrel Drug: aspirin + clopidogrel + celecoxib||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 4 Study of the Effect of Celecoxib on the Antiplatelet Effect of Aspirin and Clopidogrel|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||June 2005|
Active Comparator: ASA
aspirin 100 mg qd for 7 days
|Active Comparator: Cele||
celecoxib 200 mg bid * 7 days
|Experimental: ASA + Cele||
Drug: aspirin + celecoxib
aspirin 100 mg qd + celecoxib 200 mg bid for 7 days
|Active Comparator: ASA + Clo||
Drug: aspirin + clopidogrel
asprin 100 mg qd + clopidogrel 75 mg qd for 7 days
|Experimental: ASA + Clo + Cele||
Drug: aspirin + clopidogrel + celecoxib
aspirin 100 mg qd + clopidogrel 75 mg qd + celecoxib 200 mg bid
- Light transmittance aggregometry : % of inhibition (ADP, collagen) [ Time Frame: 7 days ]
- Urine arachidonic metabolite assay [ Time Frame: 7 days ]
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): NCT00882388
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Principal Investigator:||Hyo-Soo Kim, MD,PhD||Seoul National University Hospital|