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

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ClinicalTrials.gov Identifier: NCT00500279
Recruitment Status : Unknown
Verified July 2007 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : July 12, 2007
Last Update Posted : July 12, 2007
Sponsor:
Information provided by:
Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE July 10, 2007
First Posted Date  ICMJE July 12, 2007
Last Update Posted Date July 12, 2007
Study Start Date  ICMJE November 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2007)
late luminal loss on quantitative coronary angiography [ Time Frame: six month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2007)
target lesion revascularization, myocardial infarction, death, thrombotic events [ Time Frame: six and eighteen month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Celecoxib On Restenosis After Coronary Intervention and Evolution of Atherosclerosis Trial
Official Title  ICMJE Not Provided
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Angioplasty, Transluminal, Percutaneous Coronary
  • Coronary Restenosis
Intervention  ICMJE Drug: Celecoxib
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 10, 2007)
900
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00500279
Other Study ID Numbers  ICMJE H-0611-011-188
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hyosoo Kim, MD, PhD Seoul National University Hospital
Principal Investigator: Bonkwon Koo, MD, PhD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date July 2007

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