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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00500279
First received: July 10, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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 Intervention Phase
Angioplasty, Transluminal, Percutaneous Coronary
Coronary Restenosis
Drug: Celecoxib
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

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

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

Estimated Enrollment: 900
Study Start Date: November 2006
Estimated Study Completion Date: October 2009
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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500279

Contacts
Contact: Hyosoo Kim, MD, PhD 82-2-2072-2226 hyosoo@snu.ac.kr
Contact: Jinwook Chung, MD 80-2-2072-3757 jjw25@medimail.co.kr

Locations
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
Investigators
Principal Investigator: Hyosoo Kim, MD, PhD Seoul National University Hospital
Principal Investigator: Bonkwon Koo, MD, PhD Seoul National University Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00500279     History of Changes
Other Study ID Numbers: H-0611-011-188
Study First Received: July 10, 2007
Last Updated: July 10, 2007
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Drug-eluting stent
Restenosis
Celecoxib

Additional relevant MeSH terms:
Coronary Restenosis
Cardiovascular Diseases
Coronary Disease
Coronary Stenosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Celecoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014