NCT00272454已完成4 期
The Double-Blind, Randomized, Multi-Center, and Active Controlled Trial for Efficacy and Safety of Cilostazol in Acute Ischemic Stroke
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 468
- 试验地点
- 23
- 主要终点
- Comparison of the frequency of mRS 0, 1, 2 at 90 days
研究概览
简要总结
The purpose of this study is to study efficacy and safety of cilostazol use in patients with acute ischemic stroke.
详细描述
Stroke is a leading cause of death and elderly disability in developed countries. However, treatment of acute stroke is limited except thrombolytic therapy in hyperacute stroke within several hours. Currently, aspirin is widely used in spite of its small benefit compared to bleeding complications.
Cilostazol will be compared to aspirin in acute stroke patients in terms of functional outcome at 3 months, efficacy to prevent stroke recurrence, and safety for bleeding complications.
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
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who receive explanation on this study and give informed consent
- •Patients aged 30 to 85 years
- •Baseline NIHSS less than 15
- •Onset of symptoms within 48 hours of the start of investigational product
- •Full functional independence prior to the present stroke indicated by an mRS score of 0, 1, 2
排除标准
- •Evidence from CT or MRI scan of an acute intracranial hemorrhage, a tumor, encephalitis or any diagnosis other than acute ischemic stroke likely to cause the present symptoms.
- •Previous regular use of an antiplatelet agent or warfarin
- •Patients with known cardiac disease likely to cause cardiogenic embolism or congestive heart failure
- •Evidence from CT or MRI scan of midline shift when visiting hospital
- •Uncontrolled hypertension (SBP>220 mmHg or DBP>120 mmHg)
- •Hypotension (<90/60 mmHg)
- •Patients with known bleeding diathesis or coagulation disorder
- •Patients with liver disease (ALT>100 or AST>100), or renal disease (creatinine>2.0 mg/dl)
- •Known severe anaemia (hemoglobin<8.0 mg/dl), or thrombocytopenia (platelet<100,000/mm3)
- •Scheduled for endarterectomy within 3 months
- •Severe co-morbidity likely to limit patient's life expectancy to less than 6 months
- •Patients with alcohol or illegal drug abuse or dependency
- •Pregnant or lactating patients. When administrating to females, it should be confirmed that the patients is in the menopause (by evaluation of investigators) or permanently infertile (hysterectomy or surgical operation like bilateral tubal ligation, bilateral oophorectomy, etc). If a patient is likely to be pregnant, the patient should not be pregnant before randomization. And, the patient should use reliable contraception between at least 3 weeks before randomization to 7 days after the final administration of study drug.
- •Patients treated by thrombolytic agents like tPA after onset of stroke
结局指标
主要结局
Comparison of the frequency of mRS 0, 1, 2 at 90 days
时间窗: at 90 days
次要结局
- Frequency of mRS 0,1 at 90 days(at 90 days)
- Frequency of Barthel index 95-100 at 90 days
- Frequency of mRS 0,1 & Barthel index 95-100 at 90 days
- Frequency of NIHSS 0-1 at 90 days
- Frequency of progression of neurological deficit at 7 days (increment of NIHSS 2 points or a point on the item of upper or lower extremity weakness)
- Bleeding disorders (life-threatening bleeding; major bleeding; minor Bleeding)
- Overall cardiovascular events (Ischemic heart disease requiring rehospitalization)
研究者
研究点 (23)
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