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

Phase 4

• Conditions: Angioplasty, Transluminal, Percutaneous Coronary; Coronary Restenosis

• Registration Number: NCT00500279
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study Start: 2006-11
• Status Verified: 2007-07
• Study First Submitted: 2007-07-10
• Study First Submitted QC: 2007-07-10
• Last Update Submitted: 2007-07-10
• Study First Posted: 2007-07-12
• Last Update Posted: 2007-07-12
• Study Completion: 2009-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
late luminal loss on quantitative coronary angiography	six month

Secondary Outcome Measures

Name	Time	Method
target lesion revascularization, myocardial infarction, death, thrombotic events	six and eighteen month

Trial Locations

Locations (2)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Seuoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of