ISRCTN37694103

Trial name or title	PRESERVE Study
Methods	Randomized controlled trial, interventional
Participants	Participant inclusion criteria: Clinical evidence of cerebral small vessel disease with MRI evidence of lacunar infarcts (≤ 1.5 cm maximum diameter) and confluent leukoaraiosis (small vessel disease) (defined on Fazekas scale as ≥ grade 2). Clinical evidence of cerebral small vessel disease is defined as lacunar stroke syndrome with symptoms lasting > 24 hours. TIA lasting < 24 hours with limb weakness, hemisensory loss or dysarthria and with MRI DWI performed acutely showing lacunar infarction, or if MRI is not performed acutely (> 2 weeks after TIA) with a lacunar infarction in an anatomically appropriate position on MRI. Vascular cognitive impairment with MRI showing no evidence of hippocampal atrophy. SBP > 140 mmHg. Taking no more than two blood pressure lowering drugs at assessed for study participation. Aged 40 years or over. Not diagnosed with dementia and Mini‐Mental State Examination (MMSE) 21. Able and willing to consent. Expected life expectancy > 2 years. Able to perform study cognitive assessment. Participant exclusion criteria Unable or unwilling to consent. Women of childbearing age. MMSE < 21 or diagnosis of dementia on Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria. Life expectancy < 2 years. Symptomatic postural hypotension. Known single gene disorder causing small vessel disease (e.g. CADASI). Cortical infarction (> 2 cm maximum diameter). Symptomatic carotid stenosis or vertebral stenosis > 70% as measured on NASCET criteria
Interventions	Participants randomized to either intensive or standard blood pressure treatment. The intensive blood pressure lowering arm aims for SBP < 125 mmHg. The standard blood pressure lowering arm aims for SBP 130 to 140 mmHg, as recommended by current guidelines. The trial will compare two strategies for lowering blood pressure not looking at specific blood pressure drugs
Outcomes	Primary outcome: Composite cognitive score, which is an overall score for the cognitive tests carried out at baseline, 12 months and 24 months. Secondary outcome measures: Results of specific cognitive tests; Disability measures; Quality of life questionnaires; Blood pressure readings (taken at all visits); Record of adverse events (taken at all visits); measured at baseline, 12 months and 24 months
Starting date	14 October 2011
Contact information	Ms Eithne Smith. Stroke and Dementia Research Centre. St. George's University of London, Cranmer Terrace. London. SW17 0RE. United Kingdom preserve@sgul.ac.uk
Notes	Trial website: http://www.preserve.sgul.ac.uk