mini-COREA: Effects of Celecoxib On Restenosis After Coronary Intervention and Evolution of Atherosclerosis Trial

Sponsor

Seoul National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00500279

Collaborator

(none)

900

Enrollment

Locations

Duration (Months)

450

Patients Per Site

12.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Angioplasty, Transluminal, Percutaneous Coronary Coronary Restenosis	Drug: Celecoxib	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

900 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Nov 1, 2006

Anticipated Study Completion Date :

Oct 1, 2009

Outcome Measures

Primary Outcome Measures

late luminal loss on quantitative coronary angiography [six month]

Secondary Outcome Measures

target lesion revascularization, myocardial infarction, death, thrombotic events [six and eighteen month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam		Korea, Republic of	463-707
2	Seuoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Hyosoo Kim, MD, PhD, Seoul National University Hospital
Principal Investigator: Bonkwon Koo, MD, PhD, Seoul National University Hospital