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

Coronary Restenosis Clinical Trial

— mini-COREA  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00500279
• Other study ID #: H-0611-011-188
• 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
• 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

• Angioplasty, Transluminal, Percutaneous Coronary
• Coronary Restenosis

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