EUCTR2015-001953-33-GB进行中（未招募）1 期
Preventing cognitive decline and dementia from cerebral small vessel disease - Prevent-SVD
niversity of Edinburgh0 个研究点目标入组 60 人开始时间: 2015年8月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Mild symptomatic ischaemic stroke in the past four years compatible with a 1. Clinical lacunar stroke syndrome, with brain MRI or CT scanning that is compatible with a symptomatic small subcortical (lacunar) infarct, or if no recent relevant infarct is visible, that excluded other cause for symptoms
- •2. Age > 35 years
- •3. Independent in activities of daily living (modified Rankin =2)
- •4. Able to give consent themselves
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Other significant active neurological illness present since suffering stroke
- •(e.g. seizures, multiple sclerosis, brain tumour)
- •Montreal Cognitive Assessment score <20
- •Requiring assistance with activities of daily living (Modified Rankin =3)
- •Active cardiac disease (atrial fibrillation, myocardial infarction in past 6
- •months, active angina, symptomatic cardiac failure)
- •Carotid stenosis > 50% NASCET in the symptomatic artery territory requiring
- •carotid endarterectomy (prior and apparently successful carotid
- •endarterectomy is not an exclusion criterion)
- •Definite indication for (i.e. already prescribed either trial medication),
- •or definite contraindication to either trial drug as per SmPCs.
- •Unable to swallow
- •Bleeding tendency (platelets<100, active peptic ulcer, taking anticoagulant
- •medication)
- •Unlikely to comply with trial medication based on knowledge of past history,
- •lifestyle (cognitive impairment is an exclusion)
- •Planned surgery during the trial period
- •History of intracranial haemorrhage (subdural haematoma, subarachnoid
- •haemorrhage, intracerebral haemorrhage, but not asymptomatic haemorrhagic
- •transformation of infarction)
- •Other life threatening illness
- •History of drug overdose or attempted suicide or significant active mental
- •Pregnant or breastfeeding women, women of childbearing age not taking
- •contraception. Minimum contraception is an oral contraceptive.
- •Prohibited medications (see sections 4.5 of the SmPCs and protocol section
- •6.6.3, plus no anticoagulant drugs)
- •Renal impairment (creatinine clearance <25 ml/min)
- •Hepatic impairment
- •Current enrolment in another Clinical Trial of Investigational Medicinal
- •Product (CTIMP)
- •EXCLUSION CRITERIA FOR MRI CVR SUB-STUDY PARTICIPANTS (EDINBURGH ONLY)
- •Active respiratory illness (such as moderate to severe asthma or COPD),
- •unable to tolerate MRI or unable to lie flat
- •Claustrophobia
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