Effects of Celecoxib On Restenosis After Coronary Intervention and Evolution of Atherosclerosis Trial - Full Text View

Sponsored by:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00500279

Purpose

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

Condition	Intervention	Phase
Angioplasty, Transluminal, Percutaneous Coronary Coronary Restenosis	Drug: Celecoxib	Phase IV

MedlinePlus related topics: Heart Attack

Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

late luminal loss on quantitative coronary angiography [ Time Frame: six month ]

Secondary Outcome Measures:

target lesion revascularization, myocardial infarction, death, thrombotic events [ Time Frame: six and eighteen month ]

Estimated Enrollment:	900
Study Start Date:	November 2006
Estimated Study Completion Date:	October 2009

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.

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500279

Contacts

Contact: Hyosoo Kim, MD, PhD	82-2-2072-2226	hyosoo@snu.ac.kr
Contact: Jinwook Chung, MD	80-2-2072-3757	jjw25@medimail.co.kr

Locations

Korea, Republic of
Seuoul National University Hospital	Recruiting
Seoul, Korea, Republic of, 110-744
Seoul National University Bundang Hospital	Recruiting
Seongnam, Korea, Republic of, 463-707

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator:	Hyosoo Kim, MD, PhD	Seoul National University Hospital
Principal Investigator:	Bonkwon Koo, MD, PhD	Seoul National University Hospital

More Information

Publications:

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.

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.

Study ID Numbers:	H-0611-011-188
Study First Received:	July 10, 2007
Last Updated:	July 10, 2007
ClinicalTrials.gov Identifier:	NCT00500279
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:

Drug-eluting stent
Restenosis
Celecoxib

Study placed in the following topic categories:

Coronary Disease
Atherosclerosis
Celecoxib
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Constriction, Pathologic
Ischemia
Coronary Stenosis
Coronary Restenosis
Coronary Artery Disease

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents

Therapeutic Uses
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009