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

June 16, 2011 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Severance Hospital, Yonsei University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Collaborators

Korea Otsuka Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

December 11, 2009

First Submitted That Met QC Criteria

December 11, 2009

First Posted (Estimate)

December 14, 2009

Study Record Updates

Last Update Posted (Estimate)

June 17, 2011

Last Update Submitted That Met QC Criteria

June 16, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2009-0489

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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