NCT01142284已完成2 期
Evaluation of Concomitant Administration of Cilostazol and Probucol on Biomarkers, Endothelial Function and Safety in Peripheral Artery Disease Subjects Complicated With Coronary Artery Disease.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- On the 12-week change in FMD / Safety
研究概览
简要总结
Based upon evidence of efficacy and safety of both cilostazol and probucol administration in independent randomized controlled trials in PAD and CAD, the present trial seeks to investigate the effect of concomitant administration of cilostazol and probucol on FMD compared to each drug individually, as well as to evaluate biomarker measures and safety indices in this context.
详细描述
Primary:
- To evaluate the effect of concomitant administration of cilostazol and probucol on the 12-week change in FMD from baseline compared, with individual drugs alone.
- To assess the safety of concomitant administration of cilostazol and probucol in peripheral artery disease (PAD) subjects complicated with coronary artery disease (CAD) as determined by physical examination, vital signs, adverse events (AEs), laboratory tests, ECGs.
Secondary:
- To evaluate the effect of cilostazol and probucol administered concomitantly and as individual drugs, compared with control, on changes in FMD from baseline to Weeks 6 and 12.
- To evaluate the effect of cilostazol and probucol administered concomitantly and as individual drugs, compared with control, on changes in metabolic, inflammatory, oxidative, and platelet biomarkers from baseline to Weeks 6 and 12.
- To evaluate the effect of cilostazol and probucol administered concomitantly and as individual drugs, compared with control, on the time course (over the 12-week treatment period) of changes in FMD and biomarkers levels.
- To assess the effect of drug withdrawal on these endpoints at follow-up (from Week 12 to Week 16).
- To explore the relationship between changes in FMD and changes in the biomarker levels at Week 12.
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
- None
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age is ≥ 40 and <80 years at Screening.
- •The subject has a diagnosis of PAD
- •The subject has a diagnosis of CAD
- •Stable background medical therapy over the past 3 months
- •Taking 100mg/day of aspirin or 75mg/day of clopidogrel over the past 3 months
- •Hyperlipidemia defined as a LDL cholesterol concentration > 70 mg/dL
- •The subject is willing to participate in this study as documented by written informed consent
排除标准
- •New diagnosis of PAD within 3 months.
- •Currently taking cilostazol or has taken cilostazol
- •Currently taking probucol or has taken probucol within the last 3 months
- •Critical limb ischemia (CLI)
- •Congestive heart failure
- •Transient ischemic attack (TIA)
- •Endovascular peripheral or coronary revascularization procedure within 3 months
- •Coronary artery bypass graft (CABG) or major cardiovascular surgical procedures within 6 months
- •Major surgical procedures within 3 months
- •Uncontrolled hypertension
- •Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus
- •Diabetic complications of severe peripheral neuropathy or active retinopathy.
- •Inflammatory bowel disease.
- •Unstable angina
- •QT prolongation
- •Severe or life threatening ventricular arrhythmias
- •History of syncope
- •Serum creatinine > 2.5 mg/dL, Creatinine Clearance ≤25ml/min or renal failure requiring dialysis.
- •History or evidence of any hematological or clotting disorder.
- •Hematocrit ≤ 28% or ≥ 55%.
- •AST or ALT > 3 times the upper limit of normal (ULN).
- •Any form of chronic anticoagulation.
- •Coagulopathies defined as an INR > 1.5
- •History of malignant disease within 5 years.
- •Acute or chronic hepatitis.
- •Hemophilia or known increased risk of hemorrhage.
- •Other clinically significant disorders resulting in a remaining life expectancy less than one year.
- •Current alcohol or drug abuse.
- •If female, the subject cannot be pregnant or breastfeeding and must be of non-childbearing potential
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Cilostazol, Probucol (Drug)
Cilostazol
Experimental
cilostazol
干预措施: Cilostazol, Probucol (Drug)
Probucol
Experimental
probucol
干预措施: Cilostazol, Probucol (Drug)
Cilostazol + Probucol
Experimental
cilostazol and probucol
干预措施: Cilostazol, Probucol (Drug)
结局指标
主要结局
On the 12-week change in FMD / Safety
时间窗: 12 weeks
1. To evaluate the effect of concomitant administration of cilostazol and probucol on the 12-week change 2. To assess the safety of concomitant administration of cilostazol and probucol
次要结局
- Changes in the biomarker and FMD(12 weeks)
研究者
研究点 (1)
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