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

December 15, 2013 updated by: Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ASA
aspirin only
Drug: aspirin
aspirin 100 mg qd for 7 days
Other Names:
  • aspirin : Keun-Hwa Phamaceutical
  • clopidogrel : sanofi-aventis
  • celecoxib : Pfizer
Active Comparator: Cele
Drug: celecoxib
celecoxib 200 mg bid * 7 days
Other Names:
  • aspirin : Keun-Hwa Phamaceutical
  • clopidogrel : sanofi-aventis
  • celecoxib : Pfizer
Experimental: ASA + Cele
Drug: aspirin + celecoxib
aspirin 100 mg qd + celecoxib 200 mg bid for 7 days
Other Names:
  • aspirin : Keun-Hwa Phamaceutical
  • clopidogrel : sanofi-aventis
  • celecoxib : Pfizer
Active Comparator: ASA + Clo
Drug: aspirin + clopidogrel
asprin 100 mg qd + clopidogrel 75 mg qd for 7 days
Other Names:
  • aspirin : Keun-Hwa Phamaceutical
  • clopidogrel : sanofi-aventis
  • celecoxib : Pfizer
Experimental: ASA + Clo + Cele
Drug: aspirin + clopidogrel + celecoxib
aspirin 100 mg qd + clopidogrel 75 mg qd + celecoxib 200 mg bid
Other Names:
  • aspirin : Keun-Hwa Phamaceutical
  • clopidogrel : sanofi-aventis
  • celecoxib : Pfizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Light transmittance aggregometry : % of inhibition (ADP, collagen)
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Urine arachidonic metabolite assay
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

April 15, 2009

First Submitted That Met QC Criteria

April 15, 2009

First Posted (Estimate)

April 16, 2009

Study Record Updates

Last Update Posted (Estimate)

December 17, 2013

Last Update Submitted That Met QC Criteria

December 15, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COREA-volunteer

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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