Study design of ASPirin in Reducing Events in the Elderly (ASPREE): A randomized, controlled trial
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Cost-effective strategies to maintain healthy active lifestyle in aging populations are required to address the global burden of age-related diseases. ASPREE will examine whether the potential primary prevention benefits of low dose aspirin outweigh the risks in older healthy individuals. Our primary hypothesis is that daily oral 100. mg enteric-coated aspirin will extend a composite primary endpoint termed 'disability-free life' including onset of dementia, total mortality, or persistent disability in at least one of the Katz Activities of Daily Living in 19,000 healthy participants aged 65. years and above ('US minorities') and 70. years and above (non-'US minorities'). ASPREE is a double-blind, randomized, placebo-controlled trial of oral 100. mg enteric-coated acetyl salicylic acid (ASA) or matching placebo being conducted in Australian and US community settings on individuals free of dementia, disability and cardiovascular disease (CVD) events. Secondary endpoints are all-cause and cause specific mortality, fatal and non-fatal cardiovascular events, fatal and non-fatal cancer (excluding non-melanoma skin cancer), dementia, mild cognitive impairment, depression, physical disability, and clinically significant bleeding. To 20 September 2013 14,383 participants have been recruited. Recruitment and study completion are anticipated in July 2014 and December 2018 respectively. In contrast to other aspirin trials that have largely focused on cardiovascular endpoints, ASPREE has a unique composite primary endpoint to better capture the overall risk and benefit of aspirin to extend healthy independent lifespan in older adults in the US and Australia. © 2013 Elsevier Inc.
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Baseline Characteristics of Participants in the ASPREE (ASPirin in Reducing Events in the Elderly) StudyMcNeil, J.; Woods, R.; Nelson, M.; Murray, A.; Reid, Christopher; Kirpach, B.; Storey, E.; Shah, R.; Wolfe, R.; Tonkin, A.; Newman, A.; Williamson, J.; Lockery, J.; Margolis, K.; Ernst, M.; Abhayaratna, W.; Stocks, N.; Fitzgerald, S.; Trevaks, R.; Orchard, S.; Beilin, L.; Donnan, G.; Gibbs, P.; Johnston, C.; Grimm, R.; ASPREE Investigator Group (2017)Background: There are no primary prevention trials of aspirin with relevant geriatric outcomes in elderly people. ASPirin in Reducing Events in the Elderly (ASPREE) is a placebo-controlled trial of low-dose aspirin that ...
Slowing the progression of age-related hearing loss: Rationale and study design of the ASPIRIN in HEARING, retinal vessels imaging and neurocognition in older generations (ASPREE-HEARING) trialLowthian, J.; Britt, C.; Rance, G.; Lin, F.; Woods, R.; Wolfe, R.; Nelson, M.; Dillon, H.; Ward, S.; Reid, Christopher; Lockery, J.; Nguyen, T.; McNeil, J.; Storey, E. (2016)© 2015. Background: Age-related hearing loss (ARHL) is a leading cause of disability in the elderly. Low-grade inflammation and microvessel pathology may be responsible for initiating or exacerbating some of the hearing ...
Age-related macular degeneration in a randomized controlled trial of low-dose aspirin: Rationale and study design of the ASPREE-AMD studyRobman, L.; Guymer, R.; Woods, R.; Ward, S.; Wolfe, R.; Phung, J.; Hodgson, L.; Makeyeva, G.; Aung, K.; Gilbert, T.; Lockery, J.; Le-Pham, Y.; Orchard, S.; Storey, E.; Abhayaratna, W.; Reid, D.; Ernst, M.; Nelson, M.; Reid, Christopher; McNeil, J. (2017)Purpose: Although aspirin therapy is used widely in older adults for prevention of cardiovascular disease, its impact on the incidence, progression and severity of age-related macular degeneration (AMD) is uncertain. The ...