Effects of Celecoxib After Percutaneous Coronary Intervention

July 20, 2011 updated by: Seoul National University Hospital

Effects of Celecoxib on Restenosis After Percutaneous Coronary Intervention and Evolution of Atherosclerosis (COREA) Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Active Comparator: Celecoxib
Drug: Celecoxib
celecoxib: loading and maintenance for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Late luminal loss at 6 months
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

February 15, 2006

First Submitted That Met QC Criteria

February 15, 2006

First Posted (Estimate)

February 16, 2006

Study Record Updates

Last Update Posted (Estimate)

July 21, 2011

Last Update Submitted That Met QC Criteria

July 20, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 134-가-37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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