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

This study has been completed.
Sponsor:
Collaborator:
Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01031667
First received: December 11, 2009
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Therapy
Drug: Cilostazol, Probucol / placebo of probucol
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Plaque volume change of the index lesion with intermediate stenosis(non-PCI target lesion) [ Time Frame: From February 01, 2009 to July 31, 2011 ] [ Designated as safety issue: No ]

Enrollment: 118
Study Start Date: November 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01031667

Locations
Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
Korea Otsuka Pharmaceutical Co.,Ltd.
  More Information

No publications provided by Yonsei University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Won-Heum Shim / Professor of Cardiology at Severance Cardiovascular Hospital, Yonsei University Health System
ClinicalTrials.gov Identifier: NCT01031667     History of Changes
Other Study ID Numbers: 4-2009-0489
Study First Received: December 11, 2009
Last Updated: June 16, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
Patients treated with PCI with stent

Additional relevant MeSH terms:
Probucol
Cilostazol
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Antioxidants
Protective Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Central Nervous System Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 26, 2014