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

Information source: Yonsei University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Therapy

Intervention: Cilostazol, Probucol / placebo of probucol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Yonsei University

Summary

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.

Clinical Details

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Plaque volume change of the index lesion with intermediate stenosis(non-PCI target lesion)

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Severance Hospital, Yonsei University Health System, Seoul, Korea, Republic of
Additional Information

Starting date: November 2009
Last updated: June 16, 2011

Page last updated: August 23, 2015

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