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

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: aspirin + clopidogrel; Drug: aspirin + clopidogrel + celecoxib; Drug: aspirin + celecoxib; Drug: celecoxib; Drug: aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT00882388

COREA-volunteer

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 5 patient groups

ASA

Active Comparator group

Description:

aspirin only

Treatment:

Drug: aspirin

Cele

Active Comparator group

Treatment:

Drug: celecoxib

ASA + Cele

Experimental group

Treatment:

Drug: aspirin + celecoxib

ASA + Clo

Active Comparator group

Treatment:

Drug: aspirin + clopidogrel

ASA + Clo + Cele

Experimental group

Treatment:

Drug: aspirin + clopidogrel + celecoxib