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.
Blackburn DJ., Krishnan K., Fox L., Ballard C., Burns A., Ford GA., Mant J., Passmore P., Pocock S., Reckless J., Sprigg N., Stewart R., Wardlaw J., Bath PMW.
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.