Effects of Celecoxib On Restenosis After Coronary Intervention and Evolution of Atherosclerosis Trial
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 900
- Locations
- 4
- Primary Endpoint
- late luminal loss on quantitative coronary angiography
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
late luminal loss on quantitative coronary angiography
Time Frame: six month
Secondary Outcomes
- target lesion revascularization, myocardial infarction, death, thrombotic events(six and eighteen month)