Overview

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

Status:
Unknown status
Trial end date:
2009-10-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Seoul National University Hospital
Treatments:
Celecoxib
Criteria
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