Cognitive impairment after stroke Mental and Behavioural Disorders Other mental disorders due to brain damage and dysfunction and to physical disease
Conditions
Interventions
The trial will assess whether intensive blood pressure lowering (systolic blood pressure less than 125 mmHg) and lipid lowering (low density lipoprotein [LDL]-cholesterol less than 2.0 mmol/L) is bett
participants with haemorrhagic stroke will be randomised only to the blood pressure lowering arm.
The study will test management strategies and not individual drugs. Algorithms taking account of 'Nat
Sponsors
The University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of cognition (Addenbrooke's Cognitive Examination extended to include death) between 'intensive' and 'moderate' BP/lipid lowering groups, measured at baseline, 6, 18, 30, 42, 54, 66, 78, 90 and 96 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| For each of BP-lowering and lipid-lowering arms, comparison between 'intensive' and 'moderate' groups: 1. Dementia: measured at 6, 18, 30, 42, 54, 66, 78, 90 and 96 months - 1.1. Using alzheimers disease (AD) - National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and vascular dementia (VaD) - National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherché et l'Enseignement en Neurosciences (NINDS-AIREN) 1.2. With/without recurrent stroke 2. Cognition: all tests at 6, 18, 30, 42, 54, 66, 78, 90 and 96 months, except telephone-administered mini-mental state examination (tMMSE) and Telephone Interview for Cognitive Status (TICS-M) done at 0, 12, 24, 36, 48, 70 and 84 months over the telephone 2.1. Global - mini-mental state examination (MMSE), tMMSE, TICS 2.2. Association - trail making A/B 2.3. STROOP test 2.4. Cognitive decline with/without recurrent stroke 2.5. Ordinal cognition (MMSE greater than 28/23 - 28/10 - 22/less than 10/dementia/dead) 2.6. Informant (IQCODE) 3. Quality of life - EuroQoL, informant (DEMQoL), measured at baseline, 6, 18, 30, 42, 54, 66, 78, 90 and 96 months 4. Depression (Zung), measured at baseline, 6, 18, 30, 42, 54, 66, 78, 90 and 96 months 5. Dependency (modified Rankin Scale [mRS]), measured at baseline, 6, 18, 30, 42, 54, 66, 78, 90 and 96 months 6. Disability (Barthel Index [BI]), measured at baseline, 6, 18, 30, 42, 54, 66, 78, 90 and 96 months 7. Stroke recurrence, measured at baseline and every six months until the end of the trial 8. Myocardial infarction, measured every six months until the end of the trial 9. Composite vascular events (non-fatal stroke, non-fatal MI, fatal vascular), measured every six months until the end of the trial 10. Stroke: fatal/severe non-fatal/mild/transient ischaemic attack [TIA]/none, measured at baseline and every six months until the end of the trial 11. Myocard | — |
Countries
United Kingdom
Outcome results
None listed