The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients With Peripheral Arterial Disease (SPAD Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 801
- 主要终点
- The primary endpoint for this study is slowdown of PAD progression based on ABI.
研究概览
简要总结
The purpose of this study is to investigate the Safety and Efficacy of Cilostazol in slowing down the progression of peripheral arterial disease (PAD) in ischemic stroke patients with PAD in Taiwan.
详细描述
One thousand patients will be randomized to take cilostazol (500 patients) or placebo (500 patients) in parallel groups. Patients will be screened and evaluated on Visits 1 to assess their eligibility prior to randomization. The treatment period (Visit 1-6) will last 12 months and the patient will receive initial and follow-up evaluation (section 4.5) including history and physical examinations, and baseline and end of treatment ABI and carotid IMT assessments. Vascular events and death as well as adverse events including bleeding complications will also be recorded at intervals as detailed in section 4.5.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, age ≧50 years; for female patients, postmenopausal (defined as at least 2 years without menses) has to be confirmed.
- •Ischemic stroke or transient ischemic attack patients who have been taking aspirin 100 mg, QD
- •Neurologically and clinically stable at inclusion
- •PAD (i.e. ankle-brachial index or ABI <1.0)
排除标准
- •Patients unable to give informed consent
- •Patients with history of any type of hemorrhagic stroke (intracerebral hemorrhage,subarachnoid hemorrhage, or others)
- •Modified Rankin Scale >4
- •Patients with history of dementia requiring institutional care
- •Known brain tumor
- •Known anemia (defined as hemoglobin <10.0 g/dL)
- •Known thrombocytopenia (defined as platelet count below 100,000/cm3)
- •AST or ALT > 3 x Upper Normal Limit
- •Calculated creatinine clearance < 30 ml/min according to the Copckroft formula)
- •Known hemostasis or coagulation disorder
- •Congestive heart failure, defined as a previous definitive diagnosis, or present symptoms of at least Category II of the NYHA classification system for CHF
- •Revascularization of the lower limb arteries including bypass surgery, endovascular procedures
- •Symptomatic PAD requiring treatment with cilostazol
- •Known stenosis of the upper limb arteries that may affect the documentation of ABI
- •Patients with known hypersensitivity to cilostazol
研究组 & 干预措施
Cilostazol
Pletaal® (Cilostazol) 100 mg, bid p.o.
干预措施: Cilostazol (Drug)
placebo
Placebo
1 tablet, bid p.o.
干预措施: placebo (Other)
结局指标
主要结局
The primary endpoint for this study is slowdown of PAD progression based on ABI.
时间窗: 2 years
次要结局
- Carotid intima-media thickness(2 years)