NCT00500279

Effects of Celecoxib On Restenosis After Coronary Intervention and Evolution of Atherosclerosis Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Angioplasty, Transluminal, Percutaneous Coronary
• Coronary Restenosis

Interventions

Type	Name	Description
DRUG	Celecoxib

Timeline

• Start date: 2006-11-01
• Completion: 2009-10-01
• First posted: 2007-07-12
• Last updated: 2007-07-12

Locations

2 sites across 1 country: South Korea