Effects of Celecoxib After Percutaneous Coronary Intervention

Overview

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.

Full Title of Study: “Effects of Celecoxib on Restenosis After Percutaneous Coronary Intervention and Evolution of Atherosclerosis (COREA) Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2008

Interventions

  • Drug: Celecoxib
    • celecoxib: loading and maintenance for 6 months

Arms, Groups and Cohorts

  • No Intervention: Control
  • Active Comparator: Celecoxib

Clinical Trial Outcome Measures

Primary Measures

  • Late luminal loss at 6 months
    • Time Frame: 6 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Seoul national university hostpial, Seoul National University Hospital
  • Overall Official(s)
    • Bon-Kwon Koo, MD, PhD, Principal Investigator, Seoul National University Hospital

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