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Effects of Celecoxib After Percutaneous Coronary Intervention

Primary Purpose

Coronary Arteriosclerosis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Celecoxib
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Arteriosclerosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Celecoxib

Arm Description

Outcomes

Primary Outcome Measures

Late luminal loss at 6 months

Secondary Outcome Measures

Full Information

First Posted
February 15, 2006
Last Updated
July 20, 2011
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00292721
Brief Title
Effects of Celecoxib After Percutaneous Coronary Intervention
Official Title
Effects of Celecoxib on Restenosis After Percutaneous Coronary Intervention and Evolution of Atherosclerosis (COREA) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arteriosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Celecoxib
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
celecoxib: loading and maintenance for 6 months
Primary Outcome Measure Information:
Title
Late luminal loss at 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bon-Kwon Koo, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
20484099
Citation
Chung JW, Yang HM, Park KW, Lee HY, Park JS, Kang HJ, Cho YS, Youn TJ, Koo BK, Chae IH, Choi DJ, Oh BH, Park YB, Kim HS. Long-term outcome of adjunctive celecoxib treatment after paclitaxel-eluting stent implantation for the complex coronary lesions: two-year clinical follow-up of COREA-TAXUS trial. Circ Cardiovasc Interv. 2010 Jun 1;3(3):243-8. doi: 10.1161/CIRCINTERVENTIONS.109.889881. Epub 2010 May 18.
Results Reference
derived
PubMed Identifier
17707751
Citation
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. doi: 10.1016/S0140-6736(07)61295-1. Erratum In: Lancet. 2007 Sep 14;370(9590):828.
Results Reference
derived

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Effects of Celecoxib After Percutaneous Coronary Intervention

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