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

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: aspirin (Drug); celecoxib (Drug); aspirin + celecoxib (Drug); aspirin + clopidogrel (Drug); aspirin + clopidogrel + celecoxib (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Hyo-Soo Kim, MD,PhD, Principal Investigator, Affiliation: Seoul National University Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Light transmittance aggregometry : % of inhibition (ADP, collagen)

Secondary outcome: Urine arachidonic metabolite assay

Eligibility

Minimum age: 20 Years. Maximum age: 30 Years. Gender(s): Both.

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

Locations and Contacts

Seoul National University Hospital, Seoul 110-744, Korea, Republic of
Additional Information

Starting date: March 2005
Last updated: December 15, 2013

Page last updated: August 23, 2015

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