Clinical trial NCT00500279: Effects of Celecoxib On Restenosis After Coronary Intervention and Evolution of Atherosclerosis Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Angioplasty, Transluminal, Percutaneous Coronary
Coronary Restenosis
Keywords: Drug-eluting stent
Restenosis
Celecoxib
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2007-07-12
Enrollment: 900
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

* angina pectoris or a positive stress test with native coronary artery lesions feasible for drug-eluting stent implantation

Exclusion Criteria:

* 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%
* 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

Primary outcomes:
measure: late luminal loss on quantitative coronary angiography
timeFrame: six month
Secondary outcomes:
measure: target lesion revascularization, myocardial infarction, death, thrombotic events
timeFrame: six and eighteen month
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seuoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyosoo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Bonkwon Koo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Wang 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.