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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: aspirin + clopidogrel; Drug: aspirin + clopidogrel + celecoxib; Drug: aspirin + celecoxib; Drug: celecoxib; Drug: aspirin

• Registration Number: NCT00882388
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2009-04-15
• Study First Submitted QC: 2009-04-15
• Study First Posted: 2009-04-16
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-15
• Last Update Posted: 2013-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASA + Clo	aspirin + clopidogrel	-
ASA + Clo + Cele	aspirin + clopidogrel + celecoxib	-
ASA + Cele	aspirin + celecoxib	-
Cele	celecoxib	-
ASA	aspirin	aspirin only

Primary Outcome Measures

Name	Time	Method
Light transmittance aggregometry : % of inhibition (ADP, collagen)	7 days

Secondary Outcome Measures

Name	Time	Method
Urine arachidonic metabolite assay	7 days

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of