NCT00882388

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_4 healthy

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 16, 2009

Completed
Last Updated

December 17, 2013

Status Verified

December 1, 2013

Enrollment Period

3 months

First QC Date

April 15, 2009

Last Update Submit

December 15, 2013

Conditions

Healthy

Keywords

celecoxibplateletthrombosisVolunteers

Outcome Measures

Primary Outcomes (1)

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

    7 days

Secondary Outcomes (1)

  • Urine arachidonic metabolite assay

    7 days

Study Arms (5)

ASA

ACTIVE COMPARATOR

aspirin only

Drug: aspirin

Cele

ACTIVE COMPARATOR
Drug: celecoxib

ASA + Cele

EXPERIMENTAL
Drug: aspirin + celecoxib

ASA + Clo

ACTIVE COMPARATOR
Drug: aspirin + clopidogrel

ASA + Clo + Cele

EXPERIMENTAL
Drug: aspirin + clopidogrel + celecoxib

Interventions

aspirinDRUG

aspirin 100 mg qd for 7 days

Also known as: aspirin : Keun-Hwa Phamaceutical, clopidogrel : sanofi-aventis, celecoxib : Pfizer
ASA
celecoxibDRUG

celecoxib 200 mg bid \* 7 days

Also known as: aspirin : Keun-Hwa Phamaceutical, clopidogrel : sanofi-aventis, celecoxib : Pfizer
Cele
aspirin + celecoxibDRUG

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

Also known as: aspirin : Keun-Hwa Phamaceutical, clopidogrel : sanofi-aventis, celecoxib : Pfizer
ASA + Cele
aspirin + clopidogrelDRUG

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

Also known as: aspirin : Keun-Hwa Phamaceutical, clopidogrel : sanofi-aventis, celecoxib : Pfizer
ASA + Clo
aspirin + clopidogrel + celecoxibDRUG

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

Also known as: aspirin : Keun-Hwa Phamaceutical, clopidogrel : sanofi-aventis, celecoxib : Pfizer
ASA + Clo + Cele

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers including both men and women 20\~30 years
  • no abnormality in physical examination, 12-lead ECG, and routine laboratory test

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Thrombosis

Interventions

AspirinCelecoxibClopidogrel

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzenesulfonamidesSulfonamidesAmidesSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTiclopidineThienopyridinesThiophenesPyridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Hyo-Soo Kim, MD,PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 15, 2009

First Posted

April 16, 2009

Study Start

March 1, 2005

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

December 17, 2013

Record last verified: 2013-12

Locations

KR(1)