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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 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.
DOI: 10.1177/1747493016669848
Journal: International Journal of Stroke
PubMed URL:
Type: Journal Article
Subjects: Cerebral microbleeds
Small vessel disease
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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