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

NCT01031667 | Completed Phase 4 DMC

• 1 other identifier: 4-2009-0489
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Therapy

Keywords

Patients treated with PCI with stent

Outcome Measures

Primary Outcomes (1)

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

  From February 01, 2009 to July 31, 2011

Interventions

Cilostazol, Probucol / placebo of probucol DRUG

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead
• Korea Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

Related Publications (1)

• Ko YG, Kim BK, Lee BK, Kang WC, Choi SH, Kim SW, Lee JH, Lee M, Honda Y, Fitzerald PJ, Shim WH; SECURE Investigators. Study design and rationale of "Synergistic effect of combination therapy with cilostazol and ProbUcol on plaque stabilization and lesion REgression (SECURE)" study: a double-blind randomised controlled multicenter clinical trial. Trials. 2011 Jan 12;12:10. doi: 10.1186/1745-6215-12-10.

  PMID: 21226953 DERIVED

MeSH Terms

Interventions

Cilostazol; Probucol

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 11, 2009
• First Posted: December 14, 2009
• Study Start: November 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 17, 2011

Record last verified: 2011-06

Locations

KR (1)