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| [ ...Back to search results ] | [ Print-friendly version ] |
| Prevention Of Decline in Cognition After Stroke Trial |
| ISRCTN | ISRCTN85562386 |
| ClinicalTrials.gov identifier | |
| Public title | Prevention Of Decline in Cognition After Stroke Trial |
| Scientific title | Prevention Of Decline in Cognition After Stroke Trial (PODCAST): a factorial randomised controlled trial of intensive versus guideline (moderate) lowering of blood pressure and lipids |
| Acronym | PODCAST |
| Serial number at source | Version 1.0 |
| Study hypothesis | 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. 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. |
| Lay summary | |
| Ethics approval | Nottingham Research Ethics Committee 1 approved on the 24th July 2009 |
| Study design | Multicentre prospective randomised open-label blinded end-point controlled partial-factorial phase IV trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Cognitive impairment after stroke |
| Participants - inclusion criteria |
1. Age greater than 70 years and telephone-administered mini-mental state examination (MMSE) greater than 16; or aged greater than 60 years and telephone-MMSE 17 - 19, either sex
2. Functionally independent (modified Rankin Scale [mRS] 0 - 2) 3. Ischaemic stroke (any cortical Oxfordshire Community Stroke Project [OCSP]/Trial of ORG 10172 in Acute Stroke Treatment [TOAST] type) or primary intracerebral haemorrhage (cortical or basal ganglia) 4. Three to seven months post-event (to allow cognitive, neurological, blood pressure [BP] and lipid stabilisation, but avoid attrition) 5. Systolic BP 125 - 170 mmHg 6. Total cholesterol 3 - 8 mmol/l 7. Presence of a reporter: partner, sibling, child, friend (for Informant Questionnaire of Cognitive Decline [IQCODE]/Dementia Quality of Life [DEMQoL]) 8. Capacity and willingness to give consent |
| Participants - exclusion criteria |
1. Participants not meeting inclusion criteria
2. Subarachnoid haemorrhage 3. Secondary intracranial haemorrhage (trauma, arteriovenous malformation [AVM], cavernoma) 4. Posterior circulation ischaemic stroke 5. Posterior circulation haemorrhage 6. No computed tomography (CT)/magnetic resonance imaging (MRI) during index stroke 7. Inability to give consent or do study measures, e.g. severe dysphasia, weakness of dominant arm 8. Severe hypertension (systolic BP greater than 170 mmHg) 9. Definite need for 'intensive' BP control 10. Severe hypercholesterolemia (total cholesterol [TC] greater than 8 mmol/l) 11. Definite need for 'high intensity' statin or ezetimibe 12. Definite need for a cholinesterase inhibitor 13. Familial stroke associated with dementia, e.g. cerebral autosomal dominant arteriopathy with subcortical infarcts and leucoencephalopathy (CADASIL) 14. Chronic renal failure: glomerular filtration rate (GFR) less than 50 15. Liver disease, alanine aminotransferase (ALT) greater than 60 16. Ongoing participation in trials involving drug and/or devices, or within the last 3 months |
| Anticipated start date | 01/01/2010 |
| Anticipated end date | 01/01/2018 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 3400 participants (600 in the start-up phase and 2800 in the main phase) |
| Interventions |
The trial will assess whether intensive blood pressure lowering (systolic blood pressure less than 125 mmHg) and lipid lowering (low density lipoprotein [LDL]-cholesterol less than 2.0 mmol/L) is better than moderate blood pressure lowering (systolic blood pressure less than 140 mmHg) and cholesterol lowering (LDL-cholesterol less than 3.0 mmol/L). 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.
The total duration of the trial is 8 years and follow up for participants will range from 1 - 8 years depending on the time of enrolment. The trial intervention will be for the same duration. |
| Primary outcome measure(s) | 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 outcome measure(s) |
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 |
| Sources of funding |
Co-funded:
1. The Stroke Association (UK) (ref: TSA2008/09) 2. The Alzheimer's Society (UK) (ref: TSA 2008/09) |
| Trial website | http://www.podcast-trial.org |
| Publications | |
| Contact name | Prof Philip Bath |
| Address |
Division of Stroke Medicine
Institute of Neuroscience Clinical Sciences Building City Hospital Campus Hucknall Road |
| City/town | Notttingham |
| Zip/Postcode | NG5 1PB |
| Country | United Kingdom |
| Tel | +44 (0)115 8231765 |
| Fax | +44 (0)115 8231767 |
| Philip.Bath@nottingham.ac.uk | |
| Sponsor | The University of Nottingham (UK) |
| Address |
c/o Mr Paul Cartledge
Head of Research Grants and Contracts Research Innovation Services King's Meadow Campus Lenton Lane |
| City/town | Nottingham |
| Zip/Postcode | NG7 2NR |
| Country | United Kingdom |
| Tel | +44 (0)115 951 5679 |
| paul.cartledge@nottingham.ac.uk | |
| Sponsor website: | http://www.nottingham.ac.uk |
| Date applied | 03/08/2009 |
| Last edited | 23/09/2009 |
| Date ISRCTN assigned | 23/09/2009 |
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| © 2012 ISRCTN unless otherwise stated. | |
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