NCT00847860已完成4 期
Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White
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
- 200
- 试验地点
- 2
- 主要终点
- changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of PDE-3 inhibitor, cilostazol, in prevention and treatment of vascular dementia, in those with brain white matter lesions and vascular risk factors.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ranging from 40 to 80 years
- •After newly ischemic stroke from 3 months to 2 years
- •Brain CT or MRI shows stroke lesions and white matter lesions, ARWMC(Age Related White Matter Change)>=4
- •Moderate or mild cognitive deficits: MMSE 12-26
- •Vascular or mixed dementia: Hachinski ischemic score>4
- •Moderate or mild disability: MRS<=4,NIHSS<20
- •Informed consent
排除标准
- •Definitive diagnosis of dementia prior to the stroke
- •Cerebral hemorrhage in the past
- •Cerebral embolism result from cardiogenic embolus
- •Critically ills: MRS>4,NIHSS>=20
- •Bed-ridden patient who is hardly discovered newly stroke
- •patient with sever cardiac, hepatic or nephric complication
- •dementia caused not by vascular lesions
- •other diseases disturb the cognitive evaluation
- •susceptibility to varieties of allergen
- •abstain from Cilostazol or Asprin
- •antiplatelet treatment, anticoagulation or fibrinolysis are needed because of other diseases
- •rejected to participate by the patient or the family
研究组 & 干预措施
1
Experimental
Cilostazol
干预措施: Cilostazol (Drug)
2
Active Comparator
Asprin
干预措施: Aspirin (Drug)
结局指标
主要结局
changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth
时间窗: one year
次要结局
- stroke recurrence, other vascular ischemic events, bleeding events(one year)
研究者
研究点 (2)
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