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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00882388
First received: April 15, 2009
Last updated: December 15, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: aspirin
Drug: celecoxib
Drug: aspirin + celecoxib
Drug: aspirin + clopidogrel
Drug: aspirin + clopidogrel + celecoxib
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 4 Study of the Effect of Celecoxib on the Antiplatelet Effect of Aspirin and Clopidogrel

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Light transmittance aggregometry : % of inhibition (ADP, collagen) [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urine arachidonic metabolite assay [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2005
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882388

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Hyo-Soo Kim, MD,PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Hyo-Soo Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00882388     History of Changes
Other Study ID Numbers: COREA-volunteer
Study First Received: April 15, 2009
Last Updated: December 15, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
celecoxib
platelet
thrombosis
Volunteers

Additional relevant MeSH terms:
Celecoxib
Aspirin
Ticlopidine
Clopidogrel
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 30, 2014