title: Baseline characteristics, analysis plan and report on feasibility for the Prevention Of Decline in Cognition After Stroke Trial (PODCAST).
abstract: BACKGROUND
  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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ISRCTN85562386 registered on 23 September 2009.
authors.affiliation: Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital campus, Hucknall Road, Nottingham, NG5 1 PB, UK. polly.scutt@nottingham.ac.uk.
authors.forename: Polly
authors.initials: P
authors.lastname: Scutt
authors.affiliation: Sheffield Institute for Translational Neuroscience, University of Sheffield, 385A Glossop Road, Sheffield, S10 2HQ, UK. d.blackburn@sheffield.ac.uk.
authors.forename: Dan
authors.initials: D
authors.lastname: Blackburn
authors.affiliation: Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital campus, Hucknall Road, Nottingham, NG5 1 PB, UK. kailash.krishnan@nottingham.ac.uk.
authors.forename: Kailash
authors.initials: K
authors.lastname: Krishnan
authors.affiliation: Wolfson Center for Age-Related Diseases, Wolfson Wing, Hodgkin Building, King's College London, Guy's Campus, London, SE1 1UL, UK. clive.ballard@kcl.ac.uk.
authors.forename: Clive
authors.initials: C
authors.lastname: Ballard
authors.affiliation: Faculty of Medical and Human Sciences, Institute of Brain, Behavior and Mental Health, University of Manchester, Grafton Street, Manchester, M13 9NT, UK. alistair.burns@manchester.ac.uk.
authors.forename: Alistair
authors.initials: A
authors.lastname: Burns
authors.affiliation: Medical Sciences Division, University of Oxford, John Radcliffe Hospital, Headley Way, Oxford, OX3 9DU, UK. gary.ford@ouh.nhs.uk.
authors.forename: Gary A
authors.initials: GA
authors.lastname: Ford
authors.affiliation: General Practice & Primary Care Research Unit, University of Cambridge, Addenbrooke's Hospital, Forvie Site, Cambridge, CB2 0SR, UK. jm677@medschl.cam.ac.uk.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Mant
authors.affiliation: Institute of Clinical Sciences, Queens University, Belfast, Royal Victoria Hospital, Block B, Belfast, BT12 6BA, UK. p.passmore@qub.ac.uk.
authors.forename: Peter
authors.initials: P
authors.lastname: Passmore
authors.affiliation: Department of Medical Statistics, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. stuart.pocock@lshtm.ac.uk.
authors.forename: Stuart
authors.initials: S
authors.lastname: Pocock
authors.affiliation: Department of Endocrinology, Royal United Hospital, Combe Park, Bath, BA1 3NG, UK. mpsjpdr@bath.ac.uk.
authors.forename: John
authors.initials: J
authors.lastname: Reckless
authors.affiliation: Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital campus, Hucknall Road, Nottingham, NG5 1 PB, UK. nikola.sprigg@nottingham.ac.uk.
authors.forename: Nikola
authors.initials: N
authors.lastname: Sprigg
authors.affiliation: King's College London (Institute of Psychiatry, Psychology and Neuroscience), Department of Psychological Medicine (Box 63), De Crespigny Park, London, SE5 8AF, UK. r.stewart@iop.kcl.ac.uk.
authors.forename: Rob
authors.initials: R
authors.lastname: Stewart
authors.affiliation: Centre for Clinical Brain Sciences, Western General Hospital, Crewe Rd, Edinburgh, EH4 2XU, UK. joanna.wardlaw@ed.ac.uk.
authors.forename: Joanna M
authors.initials: JM
authors.lastname: Wardlaw
authors.affiliation: Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital campus, Hucknall Road, Nottingham, NG5 1 PB, UK. philip.bath@nottingham.ac.uk.
authors.forename: Philip M
authors.initials: PM
authors.lastname: Bath
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D001794:Blood Pressure / Q000187:drug effects; D008078:Cholesterol, LDL / Q000097:blood; D002985:Clinical Protocols; D003071:Cognition / Q000187:drug effects; D003072:Cognition Disorders / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000517:prevention & control* / Q000523:psychology; D003704:Dementia / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000517:prevention & control* / Q000523:psychology; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D000960:Hypolipidemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D009483:Neuropsychological Tests; D018579:Patient Selection; D010865:Pilot Projects; D011446:Prospective Studies; D018401:Sample Size; D020521:Stroke / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology; D000071939:Stroke Rehabilitation; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D000959:Antihypertensive Agents; D015415:Biomarkers; D008078:Cholesterol, LDL; D000960:Hypolipidemic Agents