Prevention of decline in cognition after stroke trial

Phase 4

Completed

• Conditions: Cognitive impairment after stroke; Mental and Behavioural Disorders; Other mental disorders due to brain damage and dysfunction and to physical disease

• Registration Number: ISRCTN85562386
• Lead Sponsor: The University of Nottingham (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-23
• Last Update Posted: 20 February 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3400

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified