EUCTR2007-006749-42-GB进行中（未招募）1 期
Safety and efficacy of clopidogrel when added to aspirin and dipyridamole in high risk patients with recent ischaemic stroke or TIA: a randomised controlled trial - TARDIS
niversity of Nottingham0 个研究点目标入组 3,096 人开始时间: 2008年10月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,096
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
- •Adults at high risk of recurrent ischaemic stroke:
- •1.Acute high risk TIAs <48 hours of onset All TIAs must have limb weakness and/or dysphasia lasting at least 10 minutes.
- •2.Ischaemic, non cardioembolic stroke with limb weakness, dysphasia or hemianopia =48 hours of onset with neuroimaging to rule out alternative causes.
- •3.Meaningful consent, or consent from a relative, carer or legal representative if the patient is unable to give consent (e.g. in cases of dysphasia, confusion, or reduced conscious level).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1435
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2665
排除标准
- •2.Isolated sensory symptoms or vertigo/dizziness or facial weakness
- •3.Isolated hemianopia without positive neuroimaging evidence
- •4.Intracranial haemorrhage
- •5.Baseline neuroimaging showing parenchymal haemorrhagic transformation (PH I/II) of infarct, subarachnoid haemorrhage or other non ischaemic cause for symptoms
- •6.Presumed cardioembolic stroke (e.g. history or current AF, myocardial infarction within 3 months)
- •7.Participants with contraindications to, or intolerance of, aspirin, clopidogrel or dipyridamole.
- •8.Participants with definite need for treatment with aspirin, clopidogrel or dipyridamole individually or in combination (e.g. aspirin and clopidogrel for recent MI/acute coronary syndrome)
- •9.Participant has taken clopidogrel or dipyridamole after the index event but prior to randomisation (aspirin is allowed between ictus onset and randomisation)
- •10.Definite need for full dose oral (e.g. warfarin, dabigatran) or medium to high dose parenteral (e.g. heparin) anti-coagulation. NB Low dose heparin for DVT prophylaxis is allowed
- •11.Definite need for glycoprotein IIb-IIIa inhibitors
- •12.Received thrombolysis within the last 24 hours
- •13.No enteral access
- •14.Pre-morbid dependency (mRS>2).
- •15.Severe high BP (BP>185/110 mmHg).
- •16.Haemoglobin less than 10g/dL
- •17.Platelet count more than 600 x 109 /L or less than 100 x 109 /L
- •18.White cell count more than 30 x 109 /L or less than 3.5 x 109 /L
- •19.Major bleeding within 1 year (e.g. peptic ulcer, intracerebral haemorrhage).
- •20.Planned surgery during 3 month follow-up (e.g. carotid endarterectomy)
- •21.Concomitant STEMI or NSTEMI.
- •22.Stroke secondary to a procedure (e.g. carotid or coronary intervention)
- •23.Coma (GCS<8)
- •24.Non-stroke life expectancy<6 months
- •25.Dementia
- •26.Participation in another drug or devices trial concurrently or within 30 days. (participants may take part in observational studies or non-drug or devices trials)
- •27.Geographical or other factors that may interfere with follow-up e.g. no fixed address or telephone contact number, not registered with a GP, or overseas visitor.
- •28.Females of childbearing potential, pregnancy or breastfeeding
研究者
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