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| Name | Class |
|---|---|
| Korea Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque volume change of the index lesion with intermediate stenosis(non-PCI target lesion) | From February 01, 2009 to July 31, 2011 |
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Inclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital, Yonsei University Health System | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21226953 | Derived | Ko YG, Kim BK, Lee BK, Kang WC, Choi SH, Kim SW, Lee JH, Lee M, Honda Y, Fitzerald PJ, Shim WH; SECURE Investigators. Study design and rationale of "Synergistic effect of combination therapy with cilostazol and ProbUcol on plaque stabilization and lesion REgression (SECURE)" study: a double-blind randomised controlled multicenter clinical trial. Trials. 2011 Jan 12;12:10. doi: 10.1186/1745-6215-12-10. |
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| ID | Term |
|---|---|
| D000077407 | Cilostazol |
| D011341 | Probucol |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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