Prevention of Decline in Cognition after Stroke Trial (PODCAST): a study protocol for a factorial randomised controlled trial of intensive versus guideline lowering of blood pressure and lipids

Trials

Philip MW Bath⁵  Joanna Wardlaw²  Rob Stewart⁸  Nikola Sprigg⁵  John Reckless⁷  Stuart Pocock⁶  Peter Passmore¹  Jonathan Mant^1,11  Gary A Ford^1,10  Alistair Burns⁹  Clive Ballard³  Lydia Fox⁵  Kailash Krishnan⁵  Daniel J Blackburn⁴ 

[1] Institute of Clinical Sciences, Queens University, Belfast, Royal Victoria Hospital, Block B, Belfast BT12 6BA, UK;Division of Clinical Neurosciences, Western General Hospital, Crewe Rd, Edinburgh EH4 2XU, UK;Wolfson Centre for Age-Related Diseases, Wolfson Wing, Hodgkin Building, King’s College London, Guy’s Campus, London SE1 1UL, UK;Sheffield Institute for Translational Neuroscience, University of Sheffield, 385A Glossop Road, Sheffield S10 2HQ, UK;Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital campus, Nottingham NG5 1PB, UK;Department of Medical Statistics, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK;Department of Endocrinology, Royal United Hospital, Combe Park, Bath BA1 3NG, UK;Section of Epidemiology (Box 60), Institute of Psychiatry (King's College London), De Crespigny Park, London SE5 8AF, UK;Faculty of Medical and Human Sciences, Institute of Brain, Behavior and Mental Health, University of Manchester, Grafton Street, Manchester M13 9NT, UK;Level 6, Leazes Wing, Royal Victoria Infirmary, Newcastle NE14 LP5, UK;General Practice & Primary Care Research Unit, University of Cambridge, Addenbrooke’s Hospital, Forvie Site, Cambridge CB2 0SR, UK

关键词: Lipid lowering;    Blood pressure lowering;    Post-stroke dementia;    Post-stroke cognitive impairment;    Stroke;   

Others  :  807886
DOI  :  10.1186/1745-6215-14-401

 received in 2013-07-24, accepted in 2013-10-28,  发布年份 2013

【 摘 要 】

Background

Stroke is a common cause of cognitive impairment and dementia. However, effective strategies for reducing the risk of post-stroke dementia remain undefined. Potential strategies include intensive lowering of blood pressure and/or lipids.

Methods/Design

Design: multi-centre prospective randomised open-label blinded-endpoint controlled partial-factorial phase IV trial in secondary and primary care.

Participants: 100 participants from 30 UK Stroke Research Network sites who are post- ischemic stroke or intracerebral haemorrhage by three to seven months.

Interventions - all patients (1:1): intensive versus guideline blood pressure lowering (target systolic < 125 mmHg versus < 140 mmHg).

Interventions - ischemic stroke (1:1): intensive versus guideline lipid lowering (target low density lipoprotein-cholesterol (LDL-c) < 1.4 mmol/l versus < 3 mmol/l).

Hypotheses: does ‘intensive’ blood pressure lowering therapy and/or ‘intensive’ lipid control reduce cognitive decline and dementia in people with ischemic stroke; and does ‘intensive’ blood pressure lowering therapy reduce cognitive decline and dementia in patients with hemorrhagic stroke.

Primary outcome: Addenbrooke’s Cognitive Examination-Revised.

Secondary outcomes: feasibility of recruitment and retention of participants, tolerability and safety of the interventions, achieving and maintaining the blood pressure and lipid targets, maintaining differences in systolic blood pressure (> 10 mmHg) and low density lipoprotein-cholesterol (> 1 mmol/l) between the treatment groups, and performing clinic and telephone follow-up of cognition measures.

Randomisation: using stratification, minimization and simple randomization.

Blinding: participants receive open-label management. Cognition is assessed both unblinded (in clinic) and blinded (by telephone) to treatment. Adjudication of events (dementia, vascular, serious adverse events) is blinded to management.

Discussion

The PODCAST trial is ongoing with 78 patients recruited to date from 22 sites. Outcomes of cognitive impairment and dementia are accruing.

Trial registration

ISRCTN85562386

【 授权许可】

   
2013 Blackburn et al.; licensee BioMed Central Ltd.

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