Prevention of Decline in Cognition after Stroke Trial (PODCAST): a study protocol for a factorial randomised controlled trial of intensive ... View Full Text


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Article Info

DATE

2013-11-22

AUTHORS

Daniel J Blackburn, Kailash Krishnan, Lydia Fox, Clive Ballard, Alistair Burns, Gary A Ford, Jonathan Mant, Peter Passmore, Stuart Pocock, John Reckless, Nikola Sprigg, Rob Stewart, Joanna Wardlaw, Philip MW Bath

ABSTRACT

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. More... »

PAGES

401-401

References to SciGraph publications

  • 2008-11. Statin Adverse Effects in AMERICAN JOURNAL OF CARDIOVASCULAR DRUGS
  • 2006-12-21. Administration and interpretation of the Trail Making Test in NATURE PROTOCOLS
  • Journal

    TITLE

    Trials

    ISSUE

    1

    VOLUME

    14

    Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1186/1745-6215-14-401

    DOI

    http://dx.doi.org/10.1186/1745-6215-14-401

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1026932109

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/24266960


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    20 schema:description 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.
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