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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Angioplasty, Transluminal, Percutaneous Coronary Coronary Restenosis Drug: Celecoxib Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2006
Estimated Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Primary Outcome Measures :
  1. late luminal loss on quantitative coronary angiography [ Time Frame: six month ]

Secondary Outcome Measures :
  1. target lesion revascularization, myocardial infarction, death, thrombotic events [ Time Frame: six and eighteen month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00500279

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Contact: Hyosoo Kim, MD, PhD 82-2-2072-2226
Contact: Jinwook Chung, MD 80-2-2072-3757

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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of, 463-707
Seuoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
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Principal Investigator: Hyosoo Kim, MD, PhD Seoul National University Hospital
Principal Investigator: Bonkwon Koo, MD, PhD Seoul National University Hospital

Layout table for additonal information Identifier: NCT00500279     History of Changes
Other Study ID Numbers: H-0611-011-188
First Posted: July 12, 2007    Key Record Dates
Last Update Posted: July 12, 2007
Last Verified: July 2007
Keywords provided by Seoul National University Hospital:
Drug-eluting stent
Additional relevant MeSH terms:
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Coronary Restenosis
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action