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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Aspirin; Celecoxib; Clopidogrel; Ticlopidine

Criteria

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