MedTrace Logo

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

NCT00882388 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-12-17

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

aspirin

aspirin 100 mg qd for 7 days

DRUG

celecoxib

celecoxib 200 mg bid \* 7 days

DRUG

aspirin + celecoxib

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

DRUG

aspirin + clopidogrel

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

DRUG

aspirin + clopidogrel + celecoxib

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

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Hyo-Soo Kim, MD,PhD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2005-06-30
Completion
2005-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00882388 on ClinicalTrials.gov