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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00500279
Other study ID # H-0611-011-188
Secondary ID
Status Recruiting
Phase Phase 4
First received July 10, 2007
Last updated July 10, 2007
Start date November 2006
Est. completion date October 2009

Study information

Verified date July 2007
Source Seoul National University Hospital
Contact Hyosoo Kim, MD, PhD
Phone 82-2-2072-2226
Email hyosoo@snu.ac.kr
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Celecoxib


Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam
Korea, Republic of Seuoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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

Outcome

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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