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Clinical Trials/NCT01031667
NCT01031667CompletedPhase 4

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

Yonsei University1 site in 1 country118 target enrollmentStarted: November 1, 2009Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
118
Locations
1
Primary Endpoint
Plaque volume change of the index lesion with intermediate stenosis(non-PCI target lesion)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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