Angioplasty, Transluminal, Percutaneous CoronaryPhase 4mini-COREANCT00500279
Effects of Celecoxib On Restenosis After Coronary Intervention and Evolution of Atherosclerosis Trial
A Phase 4 study testing Celecoxib in people with Angioplasty, Transluminal, Percutaneous Coronary and Coronary Restenosis, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
To evaluate the effect of celecoxib use for 3 month after drug-eluting stent implantation on restenosis on clinical outcome such as target lesion revascularization, thrombotic event, myocardial infarction, death on inflammatory biomarkers Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Angioplasty, Transluminal, Percutaneous Coronary, Coronary Restenosis
- What is being tested?
- Celecoxib
- How many people
- 900 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Nov 2006to Oct 2009
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- angina pectoris or a positive stress test with native coronary artery lesions feasible for drug-eluting stent implantation
Who cannot join
- acute or recent ST segment elevation myocardial infarction (within four weeks)
- left main coronary artery disease
- hepatic dysfunction (AST or ALT > 120 IU/L )
- renal dysfunction (serum creatinine > 2.0 mg/dl)
- severe congestive heart failure (NYHA class > 2)
- left ventricular ejection fraction < 30%
Show all 12Show fewer
- hemodynamically unstable condition
- definite intracoronary thrombus
- contraindication or history of allergy to aspirin, clopidogrel, or celecoxib
- warfarin use
- expected survival less than two years due to other medical conditions
- patients already taking any COX-3 inhibitor or NASIDS
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 463-707
- Recruiting
Seuoul National University Hospital
Seoul, 110-744
About this study
To evaluate the effect of celecoxib use for 3 month after drug-eluting stent implantation
- on restenosis
- on clinical outcome such as target lesion revascularization, thrombotic event, myocardial infarction, death
- on inflammatory biomarkers
Read the detailed description
Restenosis is the major adverse effect of coronary stent implantation. Drug-eluting stent has markedly reduced restenosis as compared with bare-metal stent, but restenosis is still the main cause of repeat coronary intervention after drug-eluting stent implantation. After coronary stent implantation, inflammatory reaction occurs in vessel wall and vascular smooth muscle cells proliferate. Celecoxib is well known to have anti-proliferative effect as well as anti-inflammatory effect, and safety of this drug is well-established. Celecoxib use for 6 month after paclitaxel-eluting stent implantation significantly reduced neointimal growth and repeat intervention without increase in adverse effect. Because inflammatory reaction seems to occur in very early period after vessel injury, reduced use of celecoxib may also be effective.
- Being tested
- Celecoxib
- Keywords
- Drug-eluting stent, Restenosis, Celecoxib
- Medical subject headings
- Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
late luminal loss on quantitative coronary angiography
Measured: six month
Secondary outcomes (1)
target lesion revascularization, myocardial infarction, death, thrombotic events
Measured: six and eighteen month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startNov 2006
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Angioplasty, Transluminal, Percutaneous CoronaryStudies 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
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hyosoo Kim, MD, PhD, Principal investigator, Seoul National University HospitalBonkwon Koo, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500279
- Sponsor's protocol ID
- H-0611-011-188
- Acronym
- mini-COREA
- Status last verified
- Jul 2007
- First submitted
- 10 Jul 2007
- Last updated
- 12 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Yang HM, Kim HS, Park KW, You HJ, Jeon SI, Youn SW, Kim SH, Oh BH, Lee MM, Park YB, Walsh K. Celecoxib, a cyclooxygenase-2 inhibitor, reduces neointimal hyperplasia through inhibition of Akt signaling. Circulation. 2004 Jul 20;110(3):301-8. doi: 10.1161/01.CIR.0000135467.43430.16. Epub 2004 Jul 6.
PubMed 15238462Wang K, Tarakji K, Zhou Z, Zhang M, Forudi F, Zhou X, Koki AT, Smith ME, Keller BT, Topol EJ, Lincoff AM, Penn MS. Celecoxib, a selective cyclooxygenase-2 inhibitor, decreases monocyte chemoattractant protein-1 expression and neointimal hyperplasia in the rabbit atherosclerotic balloon injury model. J Cardiovasc Pharmacol. 2005 Jan;45(1):61-7. doi: 10.1097/00005344-200501000-00011.
PubMed 15613981
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Celecoxib On Restenosis After Coronary Intervention and Evolution of Atherosclerosis Trial
- ClinicalTrials.gov ID
- NCT00500279
- Acronym / sponsor ID
- mini-COREA / H-0611-011-188
- Keywords
- Drug-eluting stent, Restenosis, Celecoxib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2006
- Study completion
- Oct 2009 (estimated)
- First posted
- 12 Jul 2007 (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.
To evaluate the effect of celecoxib use for 3 month after drug-eluting stent implantation
- on restenosis
- on clinical outcome such as target lesion revascularization, thrombotic event, myocardial infarction, death
- on inflammatory biomarkers
Detailed description
Restenosis is the major adverse effect of coronary stent implantation. Drug-eluting stent has markedly reduced restenosis as compared with bare-metal stent, but restenosis is still the main cause of repeat coronary intervention after drug-eluting stent implantation. After coronary stent implantation, inflammatory reaction occurs in vessel wall and vascular smooth muscle cells proliferate. Celecoxib is well known to have anti-proliferative effect as well as anti-inflammatory effect, and safety of this drug is well-established. Celecoxib use for 6 month after paclitaxel-eluting stent implantation significantly reduced neointimal growth and repeat intervention without increase in adverse effect. Because inflammatory reaction seems to occur in very early period after vessel injury, reduced use of celecoxib may also be effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- angina pectoris or a positive stress test with native coronary artery lesions feasible for drug-eluting stent implantation
Key exclusion criteria (12 listed)
- acute or recent ST segment elevation myocardial infarction (within four weeks)
- left main coronary artery disease
- hepatic dysfunction (AST or ALT > 120 IU/L )
- renal dysfunction (serum creatinine > 2.0 mg/dl)
- severe congestive heart failure (NYHA class > 2)
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 |
|---|---|---|
| Celecoxib | Drug | – |
Primary outcome
late luminal loss on quantitative coronary angiography
Time frame: six month
1 secondary outcome
target lesion revascularization, myocardial infarction, death, thrombotic events
Time frame: six and eighteen month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2007.
- Background: PubMed 15238462Yang HM, Kim HS, Park KW, You HJ, Jeon SI, Youn SW, Kim SH, Oh BH, Lee MM, Park YB, Walsh K. Celecoxib, a cyclooxygenase-2 inhibitor, reduces neointimal hyperplasia through inhibition of Akt signaling. Circulation. 2004 Jul 20;110(3):301-8. doi: 10.1161/01.CIR.0000135467.43430.16. Epub 2004 Jul 6.
- Background: PubMed 15613981Wang K, Tarakji K, Zhou Z, Zhang M, Forudi F, Zhou X, Koki AT, Smith ME, Keller BT, Topol EJ, Lincoff AM, Penn MS. Celecoxib, a selective cyclooxygenase-2 inhibitor, decreases monocyte chemoattractant protein-1 expression and neointimal hyperplasia in the rabbit atherosclerotic balloon injury model. J Cardiovasc Pharmacol. 2005 Jan;45(1):61-7. doi: 10.1097/00005344-200501000-00011.
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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.
Hyosoo Kim, MD, PhD principal investigator
Seoul National University Hospital
Bonkwon Koo, MD, PhD principal investigator
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Celecoxib in people with Angioplasty, Transluminal, Percutaneous Coronary and Coronary Restenosis, run by Seoul National University Hospital at 2 sites 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 1 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 12 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyosoo Kim, MD, PhD (82-2-2072-2226, hyosoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
late luminal loss on quantitative coronary angiography (time frame: six month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00500279, which also lists 2 linked publications.
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 12 Jul 2007.