NCT00234065已完成4 期
Post-marketing Study of Cilostazol: Study to Confirm Efficacy in Preventing Recurrent Cerebral Infarction in Comparison With Aspirin
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,800
- 试验地点
- 1
- 主要终点
- Numbers of Patients With First Occurence of Stroke
研究概览
简要总结
The purpose of this study is to investigate the efficacy of cilostazol in preventing recurrence of cerebral infarction and the safety of long-term administration of the drug (100 mg, twice daily) in patients with cerebral infarction (excluding cardiogenic cerebral embolism) in a multi-center, double-blind, parallel-group comparison with aspirin (81 mg, once daily).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stable medical conditions for 182 days (26 weeks) after occurrence of cerebral infarction
- •Patients in whom the infarct-related foci was detected by X-ray CT scan or MRI
- •Patients aged 20 to 80 years (inclusive) at time of consent
- •Patients with none of the following cardiac diseases that may be associated with cardiogenic cerebral embolism: mitral stenosis, prosthetic heart valve, endocarditis, myocardial infarction within 6 weeks after occurrence, ventricular aneurysm, endocardial thrombosis, mitral valve prolapse (patients less than 45 years of age in whom no other cause was identified), atrial fibrillation, sick sinus syndrome, idiopathic cardiomyopathy, and patent foramen ovale
- •Patients without asymptomatic cerebral infarction
- •Patients who have neither undergone nor are scheduled to undergo percutaneous transluminal angioplasty or revascularization for the treatment of cerebral infarction
- •Patients without severe disturbances/impairments following occurrence of cerebral
排除标准
- •Patients with hemorrhage or bleeding tendency (hemophilia, capillary fragility, intracranial hemorrhage, hemorrhage in the digestive tract, hemorrhage in the urinary tract, hemoptysis, and hemorrhage in the vitreous body)
- •Pregnant, possibly pregnant, or nursing women
- •Patients with ischemic heart failure
- •Patients with peptic ulcer
- •Patients with severer blood disorders
- •Patients with severe hepatic or renal
- •Patients with malignant neoplasm or patients who have received any therapy for malignant neoplasm within 5 years prior to entering the study
- •Patients with a history of hypersensitivity to salicylic acid formulations or ingredients of cilostazol tablets
- •Patients with aspirin asthma (asthma attacks induced by nonsteroidal antiinflammatory analgesic agents) or a history of aspirin asthma
- •Patients who are being treated with ticlopidine hydrochloride
- •Patients who are participating in another study for an investigational drug
- •Patients who are otherwise judged inappropriate for inclusion in the study by the investigators
研究组 & 干预措施
1
Experimental
cilostazol
干预措施: Cilostazol (Drug)
2
Active Comparator
Aspirin
干预措施: Aspirin (Drug)
结局指标
主要结局
Numbers of Patients With First Occurence of Stroke
时间窗: From start of treatment to end of follow-up period ( follow-up periods : 29 months [Standard Deviation 16, range 1-59 months])
The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction, or occurrence of cerebral haemorrhage or subarachnoid haemorrhage. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.
次要结局
- Number of Patients With First Recurrence of Cerebral Infarction(From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]))
- Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease(From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]))
- Number of Deaths From Any Cause(From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]))
- Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events(From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]))
研究者
研究点 (1)
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