Skip to main content
OpenTrials
Completed

NCT Number: NCT00882388

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin

Drug

aspirin 100 mg qd for 7 days

Other names: aspirin : Keun-Hwa Phamaceutical, clopidogrel : sanofi-aventis, celecoxib : Pfizer

Celecoxib

Drug

celecoxib 200 mg bid * 7 days

Other names: aspirin : Keun-Hwa Phamaceutical, clopidogrel : sanofi-aventis, celecoxib : Pfizer

aspirin + celecoxib

Drug

aspirin 100 mg qd + celecoxib 200 mg bid for 7 days

Other names: aspirin : Keun-Hwa Phamaceutical, clopidogrel : sanofi-aventis, celecoxib : Pfizer

Aspirin + clopidogrel

Drug

asprin 100 mg qd + clopidogrel 75 mg qd for 7 days

Other names: aspirin : Keun-Hwa Phamaceutical, clopidogrel : sanofi-aventis, celecoxib : Pfizer

aspirin + clopidogrel + celecoxib

Drug

aspirin 100 mg qd + clopidogrel 75 mg qd + celecoxib 200 mg bid

Other names: aspirin : Keun-Hwa Phamaceutical, clopidogrel : sanofi-aventis, celecoxib : Pfizer

Primary outcomes

  1. Light transmittance aggregometry : % of inhibition (ADP, collagen)

    Time frame: 7 days

Secondary outcomes

  1. Urine arachidonic metabolite assay

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Apr 16, 2009
Registry last updated
Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.