The Effect of Celecoxib on the Antiplatelet Effect of Aspirin and Clopidogrel in Normal Volunteers
Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: aspirin (Drug); celecoxib (Drug); aspirin + celecoxib (Drug); aspirin + clopidogrel (Drug); aspirin + clopidogrel + celecoxib (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Seoul National University Hospital Official(s) and/or principal investigator(s):
Hyo-Soo Kim, MD,PhD, Principal Investigator, Affiliation: Seoul National University Hospital
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.
Clinical Details
Official title: Phase 4 Study of the Effect of Celecoxib on the Antiplatelet Effect of Aspirin and Clopidogrel
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Light transmittance aggregometry : % of inhibition (ADP, collagen)
Secondary outcome: Urine arachidonic metabolite assay
Eligibility
Minimum age: 20 Years.
Maximum age: 30 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Seoul National University Hospital, Seoul 110-744, Korea, Republic of
Additional Information
Starting date: March 2005
Last updated: December 15, 2013
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