Clinical Trial: Effects of Celecoxib On Restenosis After Coronary Intervention and Evolution of Atherosclerosis Trial
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title:
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 Summary: 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.
Sponsor: Seoul National University Hospital
Current Primary Outcome: late luminal loss on quantitative coronary angiography [ Time Frame: six month ]
Original Primary Outcome: Same as current
Current Secondary Outcome: target lesion revascularization, myocardial infarction, death, thrombotic events [ Time Frame: six and eighteen month ]
Original Secondary Outcome: Same as current
Information By: Seoul National University Hospital
Dates:
Date Received: July 10, 2007
Date Started: November 2006
Date Completion: October 2009
Last Updated: July 10, 2007
Last Verified: July 2007
