Coronary Restenosis Clinical Trial
— mini-COREA
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
Status | Recruiting |
Enrollment | 900 |
Est. completion date | October 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | |
Korea, Republic of | Seuoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Wang K, Tarakji K, Zhou Z, Zhang M, Forudi F, Zhou X, Koki AT, Smith ME, Keller BT, Topol EJ, Lincoff AM, Penn MS. Celecoxib, a selective cyclooxygenase-2 inhibitor, decreases monocyte chemoattractant protein-1 expression and neointimal hyperplasia in the rabbit atherosclerotic balloon injury model. J Cardiovasc Pharmacol. 2005 Jan;45(1):61-7. — View Citation
Yang HM, Kim HS, Park KW, You HJ, Jeon SI, Youn SW, Kim SH, Oh BH, Lee MM, Park YB, Walsh K. Celecoxib, a cyclooxygenase-2 inhibitor, reduces neointimal hyperplasia through inhibition of Akt signaling. Circulation. 2004 Jul 20;110(3):301-8. Epub 2004 Jul 6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | late luminal loss on quantitative coronary angiography | six month | ||
Secondary | target lesion revascularization, myocardial infarction, death, thrombotic events | six and eighteen month |
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