Effects of Celecoxib On Restenosis After Coronary Intervention and Evolution of Atherosclerosis Trial

Study Overview
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Brief Summary
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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

Detailed Description
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Restenosis is the major adverse effect of coronary stent implantation. Drug-eluting stent has markedly reduced restenosis as compared with bare-metal stent, but restenosis is still the main cause of repeat coronary intervention after drug-eluting stent implantation. After coronary stent implantation, inflammatory reaction occurs in vessel wall and vascular smooth muscle cells proliferate. Celecoxib is well known to have anti-proliferative effect as well as anti-inflammatory effect, and safety of this drug is well-established. Celecoxib use for 6 month after paclitaxel-eluting stent implantation significantly reduced neointimal growth and repeat intervention without increase in adverse effect. Because inflammatory reaction seems to occur in very early period after vessel injury, reduced use of celecoxib may also be effective.

Conditions
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Angioplasty, Transluminal, Percutaneous Coronary, Coronary Restenosis

Intervention / Treatment
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* Drug: Celecoxib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: angina pectoris or a positive stress test with native coronary artery lesions feasible for drug-eluting stent implantation Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Celecoxib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| late luminal loss on quantitative coronary angiography |  | six month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target lesion revascularization, myocardial infarction, death, thrombotic events |  | six and eighteen month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-eluting stent, Restenosis, Celecoxib