Synergistic Effect of Combination Therapy With Cilostazol and Probucol on Plaque Stabilization and Lesion Regression: Serial Intravascular Ultrasound and Virtual Histology Study(SECURE Study)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of combination therapy with cilostazol and probucol on plaque volume and composition change in comparison with cilostazol alone by serial intravascular ultrasound and virtual histology.

Conditions
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Therapy

Intervention / Treatment
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* Drug: Cilostazol, Probucol / placebo of probucol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients treated with PCI with stent Male or female over 20 years of age Presence of at least one PCI target lesion(lesion length ≤26mm) with ≥50% diameter stenosis that can be covered with a single Endeavor Sprint stent(Medtronic) Other PCI target lesions also should be treated with Endeavor Sprint stents Presence of an intermediate non-PCI target lesion with luminal narrowing of ≥30% and ≤70% by visual estimation Signed written informed consent to participate in the study Exclusion Criteria: Intermediate (non-PCI target) lesions that might provide difficulty for IVUS evaluation because of following reasons: heavy calcification (>90° Arc), tortuous vessel with sever angulation, total occlusion, or bifurcation lesions Previous PCI in the last 6 months Previous CABG Patients with AMI undergoing primary PCI or rescue PCI after thrombolysis Cardiogenic shock Inability to take adequate anti-platelet therapy Thrombocytopenia (platelet count <70 x 109/l) Known hypersensitivity or contraindication to any of the following medications: Heparin, aspirin, clopidogrel, cilostazol, probucol, statin, contrast media* *Patients with documented sensitivity to contrast media which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled. History of severe ventricular arrhythmia Significant QTc prolongation (≥470 ms) on ECG NYHA class III/IV heart failure or LV ejection fraction ≤35% Familial hypercholesterolemia Uncontrolled hypertriglyceridemia (>400 mg/dL) Chronic renal failure with serum creatinine level ≥2mg/dL Severe liver disease or transaminase level ≥3 times the upper limit of normal. Pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 20 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cilostazol, Probucol / placebo of probucol|An investigator-initiated, placebo-controlled, randomized, multi-center study. Enrolled patients will be randomized after PCI either to the combination therapy group or to the control group. In the combination therapy group, cilostazol 200 mg and probucol 500 mg will be administered daily, whereas the control group will receive cilostazol 200 mg daily only.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque volume change of the index lesion with intermediate stenosis(non-PCI target lesion) |  | From February 01, 2009 to July 31, 2011 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients treated with PCI with stent