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OpenTrials
Completed

NCT Number: NCT01031667

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

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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Key information

Conditions

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Severe liver disease or transaminase level ≥3 times the upper limit of normal.
  • Pregnant or breastfeeding

Treatment and study plan

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.

Primary outcomes

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

    Time frame: From February 01, 2009 to July 31, 2011

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • Korea Otsuka Pharmaceutical Co., Ltd.

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 14, 2009
Registry last updated
Jun 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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