Angioplasty, Transluminal, Percutaneous Coronary, Coronary Restenosis
Conditions
Keywords
Drug-eluting stent, Restenosis, Celecoxib
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.
Interventions
DRUGCelecoxib
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| late luminal loss on quantitative coronary angiography | six month |
Secondary
| Measure | Time frame |
|---|---|
| target lesion revascularization, myocardial infarction, death, thrombotic events | six and eighteen month |
Countries
South Korea
Contacts
Primary ContactHyosoo Kim, MD, PhD
Backup ContactJinwook Chung, MD
Outcome results
None listed