HealthyPhase 4NCT00882388
The Effect of Celecoxib on the Antiplatelet Effect of Aspirin and Clopidogrel in Normal Volunteers
A Phase 4 study testing aspirin, celecoxib and aspirin + celecoxib in people with Healthy, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- aspirin, celecoxib and aspirin + celecoxib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2005to Jun 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers including both men and women 20~30 years
- no abnormality in physical examination, 12-lead ECG, and routine laboratory test
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirinDrug
Also called aspirin : Keun-Hwa Phamaceutical, clopidogrel : sanofi-aventis, celecoxib : Pfizer
aspirin 100 mg qd for 7 days
celecoxibDrug
Also called aspirin : Keun-Hwa Phamaceutical, clopidogrel : sanofi-aventis, celecoxib : Pfizer
celecoxib 200 mg bid * 7 days
aspirin + celecoxibDrug
Also called aspirin : Keun-Hwa Phamaceutical, clopidogrel : sanofi-aventis, celecoxib : Pfizer
aspirin 100 mg qd + celecoxib 200 mg bid for 7 days
aspirin + clopidogrelDrug
Also called aspirin : Keun-Hwa Phamaceutical, clopidogrel : sanofi-aventis, celecoxib : Pfizer
asprin 100 mg qd + clopidogrel 75 mg qd for 7 days
aspirin + clopidogrel + celecoxibDrug
Also called aspirin : Keun-Hwa Phamaceutical, clopidogrel : sanofi-aventis, celecoxib : Pfizer
aspirin 100 mg qd + clopidogrel 75 mg qd + celecoxib 200 mg bid
| Study group | Role | What they receive |
|---|---|---|
| ASA | Active comparator | aspirin only Receives: Drug: aspirin |
| Cele | Active comparator | Not described Receives: Drug: celecoxib |
| ASA + Cele | Experimental | Not described Receives: Drug: aspirin + celecoxib |
| ASA + Clo | Active comparator | Not described Receives: Drug: aspirin + clopidogrel |
| ASA + Clo + Cele | Experimental | Not described Receives: Drug: aspirin + clopidogrel + celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Light transmittance aggregometry : % of inhibition (ADP, collagen)
Measured: 7 days
Secondary outcomes (1)
Urine arachidonic metabolite assay
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startMar 2005
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hyo-Soo Kim, MD,PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882388
- Sponsor's protocol ID
- COREA-volunteer
- Status last verified
- Dec 2013
- First submitted
- 15 Apr 2009
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of the Effect of Celecoxib on the Antiplatelet Effect of Aspirin and Clopidogrel
- ClinicalTrials.gov ID
- NCT00882388
- Acronym / sponsor ID
- COREA-volunteer
- Conditions
- Healthy
- Keywords
- celecoxib, platelet, thrombosis, Volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 16 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ASA | Active comparator | Drug: aspirinaspirin only |
| 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 |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy volunteers including both men and women 20~30 years
- no abnormality in physical examination, 12-lead ECG, and routine laboratory test
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aspirinAlso: aspirin : Keun-Hwa Phamaceutical, clopidogrel : sanofi-aventis, celecoxib : Pfizeraspirin 100 mg qd for 7 days | Drug | ASA |
| celecoxibAlso: aspirin : Keun-Hwa Phamaceutical, clopidogrel : sanofi-aventis, celecoxib : Pfizercelecoxib 200 mg bid * 7 days | Drug | Cele |
| aspirin + celecoxibAlso: aspirin : Keun-Hwa Phamaceutical, clopidogrel : sanofi-aventis, celecoxib : Pfizeraspirin 100 mg qd + celecoxib 200 mg bid for 7 days | Drug | ASA + Cele |
| aspirin + clopidogrelAlso: aspirin : Keun-Hwa Phamaceutical, clopidogrel : sanofi-aventis, celecoxib : Pfizerasprin 100 mg qd + clopidogrel 75 mg qd for 7 days | Drug | ASA + Clo |
| aspirin + clopidogrel + celecoxibAlso: aspirin : Keun-Hwa Phamaceutical, clopidogrel : sanofi-aventis, celecoxib : Pfizeraspirin 100 mg qd + clopidogrel 75 mg qd + celecoxib 200 mg bid | Drug | ASA + Clo + Cele |
Primary outcome
Light transmittance aggregometry : % of inhibition (ADP, collagen)
Time frame: 7 days
1 secondary outcome
Urine arachidonic metabolite assay
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyo-Soo Kim, MD,PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aspirin, celecoxib and aspirin + celecoxib in people with Healthy, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Light transmittance aggregometry : % of inhibition (ADP, collagen) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2013.