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:
Yonsei University
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
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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:
- 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
Contacts and Locations
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 May 23, 2013