Prevention Of Decline in Cognition After Stroke Trial "PODCAST "

Active, not recruiting

Phase N/A Results N/A

Trial Description

To study if intensive blood pressure and/or lipid lowering post stroke, is better than moderate blood pressure and/or lipid lowering, to prevent cognitive decline after stroke.

Interventions

Trial Design

Multicentre prospective randomised open-label blinded end-point controlled partial-factorial phase IV trial

Patient Involvement

Participants with ischaemic stroke will be randomised to both the blood pressure and lipid lowering arms; participants with haemorrhagic stroke will be randomised only to the blood pressure lowering arm. Primary and secondary outcomes will be measured using methods and at the intervals indicated above.

The study will test management strategies and not individual drugs. Algorithms taking account of 'National Institute of Clinical Excellence, UK Guidelines', relating to stroke, hypertension, lipids and Type 2 Diabetes will aid investigators in treatment decision-making using standard antihypertensive and lipid lowering drugs so that participants are treated as randomised.

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 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. Myocardial infarction: fatal/non-fatal/angina/none, measured at baseline and every six months until the end of the trial 12. Vascular: fatal/non-fatal/none, measured at baseline and every six months until the end of the trial 13. New diabetes, measured at baseline, 6, 18, 30, 42, 54, 66, 78, 90 and 96 months 14. New atrial fibrillation, measured at baseline, 6, 18, 30, 42, 54, 66, 78, 90 and 96 months 15. Residence (home, institution), care package, informal family support, measured at baseline, 6, 18, 30, 42, 54, 66, 78, 90 and 96 months 16. Blood pressure (systolic BP, diastolic BP, pulse pressure, rate-pressure product), measured at baseline, 6, 18, 30, 42, 54, 66, 78, 90 and 96 months 17. Lipids (total cholesterol [TC], triglycerides [TG], HDL, calculated LDL), measured at baseline, 6, 18, 30, 42, 54, 66, 78, 90 and 96 months 18. Neuroimaging (in a subset of participants), measured at baseline and at 3 years

Sponsors

The University of Nottingham (UK)