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dc.contributor.authorScutt, Polly
dc.contributor.authorBlackburn, Dan
dc.contributor.authorKrishnan, Kailash
dc.contributor.authorBallard, Clive
dc.contributor.authorBurns, Alistair
dc.contributor.authorFord, Gary A
dc.contributor.authorMant, Jonathan
dc.contributor.authorPassmore, Peter
dc.contributor.authorPocock, Stuart
dc.contributor.authorReckless, John
dc.contributor.authorSprigg, Nikola
dc.contributor.authorStewart, Rob
dc.contributor.authorWardlaw, Joanna M
dc.contributor.authorBath, Philip M
dc.date.accessioned2018-05-02T17:26:17Z
dc.date.available2018-05-02T17:26:17Z
dc.date.issued2015-11-07
dc.identifier.issn1745-6215
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/275459
dc.description.abstractBACKGROUND: A common complication after stroke is development of cognitive impairment and dementia. However, effective strategies for reducing the risk of developing these problems remain undefined. Potential strategies include intensive lowering of blood pressure (BP) and/or lipids. This paper summarises the baseline characteristics, statistical analysis plan and feasibility of a randomised control trial of blood pressure and lipid lowering in patients post-stroke with the primary objective of reducing cognitive impairment and dementia. METHODS: The Prevention Of Decline in Cognition After Stroke Trial (PODCAST) was a multi-centre prospective randomised open-label blinded-endpoint controlled partial-factorial internal pilot trial running in secondary and primary care. Participants without dementia were enrolled 3-7 months post ischaemic stroke or spontaneous intracerebral haemorrhage, and randomised to intensive versus guideline BP lowering (target systolic BP <125 mmHg versus <140 mmHg); patients with ischaemic stroke were also randomised to intensive or guideline lipid lowering (target LDL cholesterol <1.4 mmol/L versus <3 mmol/L). The primary outcome was the Addenbrooke's Cognitive Examination-Revised; a key secondary outcome was to assess feasibility of performing a large trial of one or both interventions. Data are number (%) or mean (standard deviation). The trial was planned to last for 8 years with follow-up between 1 and 8 years. The plan for reporting the main results is included as Additional file 2. RESULTS: 83 patients (of a planned 600) were recruited from 19 UK sites between 7 October 2010 and 31 January 2014. Delays, due to difficulties in the provision of excess treatment costs and to complexity of follow-up, led to few centres taking part and a much lower recruitment rate than planned. Patient characteristics at baseline were: age 74 (SD 7) years, male 64 (77 %), index stroke ischaemic 77 (93 %), stroke onset to randomisation 4.5 [SD 1.3] months, Addenbrooke's Cognitive Examination-Revised 86 (of 100, SD 8), Montreal Cognitive Assessment 24 (of 30, SD 3), BP 147/82 (SD 19/11) mmHg, total cholesterol 4.0 (SD 0.8) mmol/L and LDL cholesterol 2.0 (SD 0.7) mmol/L, modified Rankin Scale 1.1 (SD 0.8). CONCLUSION: Limited recruitment suggests that a large trial is not feasible using the current protocol. The effects of the interventions on BP, lipids, and cognition will be reported in the main publication. TRIAL REGISTRATION: ISRCTN85562386 registered on 23 September 2009.
dc.format.mediumElectronic
dc.languageeng
dc.publisherSpringer Science and Business Media LLC
dc.rightsAttribution 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectHumans
dc.subjectDementia
dc.subjectAntihypertensive Agents
dc.subjectTreatment Outcome
dc.subjectClinical Protocols
dc.subjectProspective Studies
dc.subjectFeasibility Studies
dc.subjectPilot Projects
dc.subjectSample Size
dc.subjectCognition
dc.subjectCognition Disorders
dc.subjectNeuropsychological Tests
dc.subjectBlood Pressure
dc.subjectPatient Selection
dc.subjectTime Factors
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectFemale
dc.subjectMale
dc.subjectCholesterol, LDL
dc.subjectStroke
dc.subjectHypolipidemic Agents
dc.subjectBiomarkers
dc.subjectUnited Kingdom
dc.subjectStroke Rehabilitation
dc.titleBaseline characteristics, analysis plan and report on feasibility for the Prevention Of Decline in Cognition After Stroke Trial (PODCAST).
dc.typeArticle
prism.publicationDate2015
prism.publicationNameTrials
prism.startingPage509
prism.volume16
dc.identifier.doi10.17863/CAM.22682
dcterms.dateAccepted2015-10-27
rioxxterms.versionofrecord10.1186/s13063-015-1033-2
rioxxterms.versionVoR
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.licenseref.startdate2015-11-07
dc.contributor.orcidMant, Jonathan [0000-0002-9531-0268]
dc.identifier.eissn1745-6215
rioxxterms.typeJournal Article/Review
cam.issuedOnline2015-11-07


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Attribution 4.0 International
Except where otherwise noted, this item's licence is described as Attribution 4.0 International