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

NCT ID: NCT00500279

Last Updated: 2007-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-10-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Angioplasty, Transluminal, Percutaneous Coronary Coronary Restenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Celecoxib

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Hyosoo Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Bonkwon Koo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status RECRUITING

Seuoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyosoo Kim, MD, PhD

Role: CONTACT

[email protected]
82-2-2072-2226

Jinwook Chung, MD

Role: CONTACT

[email protected]
80-2-2072-3757

References

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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. doi: 10.1161/01.CIR.0000135467.43430.16. Epub 2004 Jul 6.

Reference Type BACKGROUND
PMID: 15238462 (View on PubMed)

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. doi: 10.1097/00005344-200501000-00011.

Reference Type BACKGROUND
PMID: 15613981 (View on PubMed)

Other Identifiers

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H-0611-011-188

Identifier Type: -

Identifier Source: org_study_id