Effects of Celecoxib On Restenosis After Coronary Intervention and Evolution of Atherosclerosis Trial
mini-COREA
1 other identifier
interventional
900
1 country
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2006
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 10, 2007
CompletedFirst Posted
Study publicly available on registry
July 12, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedJuly 12, 2007
July 1, 2007
July 10, 2007
July 10, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
late luminal loss on quantitative coronary angiography
six month
Secondary Outcomes (1)
target lesion revascularization, myocardial infarction, death, thrombotic events
six and eighteen month
Interventions
Eligibility Criteria
You may qualify if:
- angina pectoris or a positive stress test with native coronary artery lesions feasible for drug-eluting stent implantation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Seoul National University Bundang Hospital
Seongnam, 463-707, South Korea
Seuoul National University Hospital
Seoul, 110-744, South Korea
Related Publications (2)
Yang HM, Kim HS, Park KW, You HJ, Jeon SI, Youn SW, Kim SH, Oh BH, Lee MM, Park YB, Walsh K. Celecoxib, a cyclooxygenase-2 inhibitor, reduces neointimal hyperplasia through inhibition of Akt signaling. Circulation. 2004 Jul 20;110(3):301-8. doi: 10.1161/01.CIR.0000135467.43430.16. Epub 2004 Jul 6.
PMID: 15238462BACKGROUNDWang K, Tarakji K, Zhou Z, Zhang M, Forudi F, Zhou X, Koki AT, Smith ME, Keller BT, Topol EJ, Lincoff AM, Penn MS. Celecoxib, a selective cyclooxygenase-2 inhibitor, decreases monocyte chemoattractant protein-1 expression and neointimal hyperplasia in the rabbit atherosclerotic balloon injury model. J Cardiovasc Pharmacol. 2005 Jan;45(1):61-7. doi: 10.1097/00005344-200501000-00011.
PMID: 15613981BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyosoo Kim, MD, PhD
Seoul National University Hospital
- PRINCIPAL INVESTIGATOR
Bonkwon Koo, MD, PhD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 10, 2007
First Posted
July 12, 2007
Study Start
November 1, 2006
Study Completion
October 1, 2009
Last Updated
July 12, 2007
Record last verified: 2007-07