Prevention Of Decline in Cognition After Stroke Trial (PODCAST): a factorial randomised controlled trial of intensive versus guideline (moderate) lowering of blood pressure and lipids

The University of Nottingham (UK)0 个研究点目标入组 3,400 人开始时间: 2009年9月23日最近更新: 2017年2月20日

适应症

试验速览

暂无简介。

•1. Age greater than 70 years and telephone-administered mini-mental state examination (MMSE) greater than 16; or aged greater than 60 years and telephone-MMSE 17 - 19, either sex
•2. Functionally independent (modified Rankin Scale [mRS] 0 - 2)
•3. Ischaemic stroke (any cortical Oxfordshire Community Stroke Project [OCSP]/Trial of ORG 10172 in Acute Stroke Treatment [TOAST] type) or primary intracerebral haemorrhage (cortical or basal ganglia)
•4. Three to seven months post-event (to allow cognitive, neurological, blood pressure [BP] and lipid stabilisation, but avoid attrition)
•5. Systolic BP 125 - 170 mmHg
•6. Total cholesterol 3 - 8 mmol/l
•7. Presence of a reporter: partner, sibling, child, friend (for Informant Questionnaire of Cognitive Decline [IQCODE]/Dementia Quality of Life [DEMQoL])
•8. Capacity and willingness to give consent

•1. Participants not meeting inclusion criteria
•2. Subarachnoid haemorrhage
•3. Secondary intracranial haemorrhage (trauma, arteriovenous malformation [AVM], cavernoma)
•4. Posterior circulation ischaemic stroke
•5. Posterior circulation haemorrhage
•6. No computed tomography (CT)/magnetic resonance imaging (MRI) during index stroke
•7. Inability to give consent or do study measures, e.g. severe dysphasia, weakness of dominant arm
•8. Severe hypertension (systolic BP greater than 170 mmHg)
•9. Definite need for 'intensive' BP control
•10. Severe hypercholesterolemia (total cholesterol [TC] greater than 8 mmol/l)
•11. Definite need for 'high intensity' statin or ezetimibe
•12. Definite need for a cholinesterase inhibitor
•13. Familial stroke associated with dementia, e.g. cerebral autosomal dominant arteriopathy with subcortical infarcts and leucoencephalopathy (CADASIL)
•14. Chronic renal failure: glomerular filtration rate (GFR) less than 50
•15. Liver disease, alanine aminotransferase (ALT) greater than 60
•16. Ongoing participation in trials involving drug and/or devices, or within the last 3 months

发起方

The University of Nottingham (UK)