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

NCT ID: NCT00882388

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-06-30

Brief Summary

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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

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Conditions

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Healthy

Keywords

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celecoxib platelet thrombosis Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ASA

aspirin only

Group Type ACTIVE_COMPARATOR

aspirin

Intervention Type DRUG

aspirin 100 mg qd for 7 days

Cele

Group Type ACTIVE_COMPARATOR

celecoxib

Intervention Type DRUG

celecoxib 200 mg bid \* 7 days

ASA + Cele

Group Type EXPERIMENTAL

aspirin + celecoxib

Intervention Type DRUG

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

ASA + Clo

Group Type ACTIVE_COMPARATOR

aspirin + clopidogrel

Intervention Type DRUG

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

ASA + Clo + Cele

Group Type EXPERIMENTAL

aspirin + clopidogrel + celecoxib

Intervention Type DRUG

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

Interventions

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aspirin

aspirin 100 mg qd for 7 days

Intervention Type DRUG

celecoxib

celecoxib 200 mg bid \* 7 days

Intervention Type DRUG

aspirin + celecoxib

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

Intervention Type DRUG

aspirin + clopidogrel

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

Intervention Type DRUG

aspirin + clopidogrel + celecoxib

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

Intervention Type DRUG

Other Intervention Names

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aspirin : Keun-Hwa Phamaceutical clopidogrel : sanofi-aventis celecoxib : Pfizer aspirin : Keun-Hwa Phamaceutical clopidogrel : sanofi-aventis celecoxib : Pfizer aspirin : Keun-Hwa Phamaceutical clopidogrel : sanofi-aventis celecoxib : Pfizer aspirin : Keun-Hwa Phamaceutical clopidogrel : sanofi-aventis celecoxib : Pfizer aspirin : Keun-Hwa Phamaceutical clopidogrel : sanofi-aventis celecoxib : Pfizer

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Hospital

Principal Investigators

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Hyo-Soo Kim, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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COREA-volunteer

Identifier Type: -

Identifier Source: org_study_id