Effects of Celecoxib After Percutaneous Coronary Intervention - Tabular View

Tracking Information

First Received Date ^ICMJE

February 15, 2006

Last Updated Date

April 18, 2007

Start Date ^ICMJE

August 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Late luminal loss at 6 months

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00292721 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Major adverse cardiac events

Original Secondary Outcome Measures ^ICMJE

Major adverse cardic events

Descriptive Information

Brief Title ^ICMJE

Effects of Celecoxib After Percutaneous Coronary Intervention

Official Title ^ICMJE

Effects of Celecoxib on Restenosis After Percutaneous Coronary Intervention and Evolution of Atherosclerosis (COREA) Trial

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Coronary Arteriosclerosis

Intervention ^ICMJE

Drug: Celecoxib

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

260

Estimated Completion Date

October 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT ID ^ICMJE

NCT00292721

Responsible Party

Study ID Numbers ^ICMJE

134-가-37

Study Sponsor ^ICMJE

Seoul National University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Bon-Kwon Koo, MD, PhD

Seoul National University Hospital

Information Provided By

Seoul National University Hospital

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP