NCT01031667已完成4 期
Synergistic Effect of Combination Therapy With Cilostazol and Probucol on Plaque Stabilization and Lesion Regression: Serial Intravascular Ultrasound and Virtual Histology Study(SECURE Study)
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Plaque volume change of the index lesion with intermediate stenosis(non-PCI target lesion)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Plaque volume change of the index lesion with intermediate stenosis(non-PCI target lesion)
时间窗: From February 01, 2009 to July 31, 2011
次要结局
未报告次要终点
研究者
研究点 (2)
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