Effects of Celecoxib After Percutaneous Coronary Intervention

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00292721
First received: February 15, 2006
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Coronary Arteriosclerosis
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
Official Title: Effects of Celecoxib on Restenosis After Percutaneous Coronary Intervention and Evolution of Atherosclerosis (COREA) Trial

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Late luminal loss at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: August 2004
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Active Comparator: Celecoxib Drug: Celecoxib
celecoxib: loading and maintenance for 6 months

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292721

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Bon-Kwon Koo, MD, PhD Seoul National University Hospital
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seoul national university hostpial, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00292721     History of Changes
Other Study ID Numbers: 134-가-37
Study First Received: February 15, 2006
Last Updated: July 20, 2011
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014