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Effects of Celecoxib After Percutaneous Coronary Intervention

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ClinicalTrials.gov Identifier: NCT00292721
Recruitment Status : Completed
First Posted : February 16, 2006
Last Update Posted : July 21, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Arteriosclerosis Drug: Celecoxib Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Celecoxib on Restenosis After Percutaneous Coronary Intervention and Evolution of Atherosclerosis (COREA) Trial
Study Start Date : August 2004
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Late luminal loss at 6 months [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 16, 2006    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: July 2011

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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents