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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-06-30

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.

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Detailed Description

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Conditions

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Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients treated with PCI with stent
2. Male or female over 20 years of age
3. 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)
4. Other PCI target lesions also should be treated with Endeavor Sprint stents
5. Presence of an intermediate non-PCI target lesion with luminal narrowing of ≥30% and ≤70% by visual estimation
6. Signed written informed consent to participate in the study

Exclusion Criteria

1. 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
2. Previous PCI in the last 6 months
3. Previous CABG
4. Patients with AMI undergoing primary PCI or rescue PCI after thrombolysis
5. Cardiogenic shock
6. Inability to take adequate anti-platelet therapy
7. Thrombocytopenia (platelet count \<70 x 109/l)
8. 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.
9. History of severe ventricular arrhythmia
10. Significant QTc prolongation (≥470 ms) on ECG
11. NYHA class III/IV heart failure or LV ejection fraction ≤35%
12. Familial hypercholesterolemia
13. Uncontrolled hypertriglyceridemia (\>400 mg/dL)
14. Chronic renal failure with serum creatinine level ≥2mg/dL
15. Severe liver disease or transaminase level ≥3 times the upper limit of normal.
16. Pregnant or breastfeeding

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No