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

Primary Purpose

Angioplasty, Transluminal, Percutaneous Coronary, Coronary Restenosis

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

About this trial

This is an interventional treatment trial for Angioplasty, Transluminal, Percutaneous Coronary focused on measuring Drug-eluting stent, Restenosis, Celecoxib

Eligibility Criteria

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

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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting
  • Seuoul National University HospitalRecruiting

Outcomes

Primary Outcome Measures

late luminal loss on quantitative coronary angiography

Secondary Outcome Measures

target lesion revascularization, myocardial infarction, death, thrombotic events

Full Information

First Posted
July 10, 2007
Last Updated
July 10, 2007
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00500279
Brief Title
Effects of Celecoxib On Restenosis After Coronary Intervention and Evolution of Atherosclerosis Trial
Acronym
mini-COREA
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angioplasty, Transluminal, Percutaneous Coronary, Coronary Restenosis
Keywords
Drug-eluting stent, Restenosis, Celecoxib

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Celecoxib
Primary Outcome Measure Information:
Title
late luminal loss on quantitative coronary angiography
Time Frame
six month
Secondary Outcome Measure Information:
Title
target lesion revascularization, myocardial infarction, death, thrombotic events
Time Frame
six and eighteen month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyosoo Kim, MD, PhD
Phone
82-2-2072-2226
Email
hyosoo@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Jinwook Chung, MD
Phone
80-2-2072-3757
Email
jjw25@medimail.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyosoo Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bonkwon Koo, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seuoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
15238462
Citation
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.
Results Reference
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PubMed Identifier
15613981
Citation
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.
Results Reference
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Effects of Celecoxib On Restenosis After Coronary Intervention and Evolution of Atherosclerosis Trial

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