Effects of Celecoxib After Percutaneous Coronary Intervention

This study is ongoing, but not recruiting participants.

First Received: February 15, 2006 Last Updated: April 18, 2007 History of Changes

Sponsor:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00292721

Purpose

Several studies including ours have reported that celecoxib improves endothelium-dependent vasodilation and reduces inflammation and neointimal hyperplasia. Our hypothesis is that celecoxib may reduce the late luminal loss after coronary stent implantation (paclitaxel-eluting stent.

Condition	Intervention	Phase
Coronary Arteriosclerosis	Drug: Celecoxib	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effects of Celecoxib on Restenosis After Percutaneous Coronary Intervention and Evolution of Atherosclerosis (COREA) Trial

Resource links provided by NLM:

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 at 6 months

Secondary Outcome Measures:

Major adverse cardiac events

Estimated Enrollment:	260
Study Start Date:	August 2004
Estimated Study Completion Date:	October 2008

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Coronary artery disease with at least 1 de novo lesion greater than 50% stenosis on coronary angiography

Exclusion Criteria:

Acute ST elevation MI
Left main disease
Contraindications to aspirin, clopidogrel or celecoxib
Severe congestive heart failure
Expected survival < 2 years
Hepatic dysfunction
Currently taking NSAIDs or any COX-2 inhibitor
Renal dysfunction
Use of warfarin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292721

Locations

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator:

Bon-Kwon Koo, MD, PhD

Seoul National University Hospital

More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Koo BK, Kim YS, Park KW, Yang HM, Kwon DA, Chung JW, Hahn JY, Lee HY, Park JS, Kang HJ, Cho YS, Youn TJ, Chung WY, Chae IH, Choi DJ, Oh BH, Park YB, Kim HS. Effect of celecoxib on restenosis after coronary angioplasty with a Taxus stent (COREA-TAXUS trial): an open-label randomised controlled study. Lancet. 2007 Aug 18;370(9587):567-74.

Study ID Numbers:	134-가-37
Study First Received:	February 15, 2006
Last Updated:	April 18, 2007
ClinicalTrials.gov Identifier:	NCT00292721 History of Changes
Health Authority:	Korea: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Arterial Occlusive Diseases
Heart Diseases
Celecoxib
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Vascular Diseases
Enzyme Inhibitors
Arteriosclerosis
Pharmacologic Actions

Coronary Disease
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Cardiovascular Diseases
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Coronary Artery Disease

ClinicalTrials.gov processed this record on November 27, 2009