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https://ahro.austin.org.au/austinjspui/handle/1/16440| Title: | ASPREE-NEURO study protocol: a randomized controlled trial to determine the effect of low-dose aspirin on cerebral microbleeds, white matter hyperintensities, cognition, and stroke in the healthy elderly | Austin Authors: | Ward, Stephanie A;Raniga, Parnesh;Ferris, Nicholas J;Woods, Robyn L;Storey, Elsdon;Bailey, Michael J;Brodtmann, Amy ;Yates, Paul A ;Donnan, Geoffrey A ;Trevaks, Ruth E;Wolfe, Rory;Egan, Gary F;McNeil, John J;ASPREE investigator group | Affiliation: | Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia Monash Ageing Research Centre (MONARC) Monash University, The Kingston Centre, Cheltenham, Victoria, Australia Monash Biomedical Imaging & ARC Centre of Excellence for Integrative Brain Function, Monash University, Clayton, Victoria, Australia Monash Imaging, Monash Health, Clayton, Victoria, Australia Department of Medicine (Neuroscience), Monash University, Melbourne, Victoria, Australia Department of Epidemiology and Preventive Medicine, Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia Behavioural Neuroscience, Florey Institute for Neuroscience and Mental Health, Melbourne Brain Centre, Heidelberg, Victoria, Australia Department of Aged Care Services, Austin Health, Heidelberg, Victoria, Australia The Florey Institute of Neuroscience and Mental Health, Parkville, Victoria, Australia |
Issue Date: | Jan-2017 | Date: | 2016-09-15 | Publication information: | International Journal of Stroke 2017; 12(1): 108-113 | Abstract: | RATIONALE: Cerebral microbleeds seen on brain magnetic resonance imaging are markers of small vessel disease, linked to cognitive dysfunction and increased ischemic and hemorrhagic stroke risk. Observational studies suggest that aspirin use may induce cerebral microbleeds, and associated overt intracranial hemorrhage, but this has not been definitively resolved. AIMS: ASPREE-NEURO will determine the effect of aspirin on cerebral microbleed development over three years in healthy adults aged 70 years and over, participating in the larger 'ASPirin in Reducing Events in the Elderly (ASPREE)' primary prevention study of aspirin. SAMPLE SIZE: Five hundred and fifty-nine participants provide 75% power (two-sided p value of 0.05) to determine an average difference of 0.5 cerebral microbleed per person after three years. METHODS AND DESIGN: A multi-center, randomized placebo-controlled trial of 100 mg daily aspirin in participants who have brain magnetic resonance imaging at study entry, one and three years after randomization and who undergo cognitive testing at the same time points. STUDY OUTCOMES: The primary outcome is the number of new cerebral microbleeds on magnetic resonance imaging after three years. Secondary outcomes are the number of new cerebral microbleeds after one year, change in volume of white matter hyperintensity, cognitive function, and stroke. DISCUSSION: ASPREE-NEURO will resolve whether aspirin affects the presence and number of cerebral microbleeds, their relationship with cognitive performance, and indicate whether consideration of cerebral microbleeds alters the risk-benefit profile of aspirin in primary prevention for older people. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12613001313729. | URI: | https://ahro.austin.org.au/austinjspui/handle/1/16440 | DOI: | 10.1177/1747493016669848 | Journal: | International Journal of Stroke | PubMed URL: | https://pubmed.ncbi.nlm.nih.gov/27634976 | Type: | Journal Article | Subjects: | Cerebral microbleeds Small vessel disease Neuroimaging Aspirin Dementia Cognitive decline Healthy aging |
Type of Clinical Study or Trial: | Randomized Controlled Clinical Trial/Controlled Clinical Trial |
| Appears in Collections: | Journal articles |
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