Effects of Celecoxib On Restenosis After Coronary Intervention and Evolution of Atherosclerosis Trial (mini-COREA)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2007 by Seoul National University Hospital.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT00500279

First received: July 10, 2007

Last updated: NA

Last verified: July 2007

History: No changes posted

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 4

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

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Atherosclerosis Heart Attack

Drug Information available for: Celecoxib

U.S. FDA Resources

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

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.

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

Keywords provided by Seoul National University Hospital:

Drug-eluting stent
Restenosis
Celecoxib

Additional relevant MeSH terms:

Coronary Restenosis
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 16, 2013

To Top