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Study design of ASPirin in Reducing Events in the Elderly (ASPREE): A randomized, controlled trial


Grimm, R and McNeil, JJ and Applegate, W and Beilin, L and Espinoza, S and Johnston, CI and Kirpach, B and Margolis, K and Murray, A and Nelson, MR and Reid, CM and Shah, RC and Storey, E and Tonkin, AM and Wilson, P and Wolfe, R and Woods, RL and Abhayaratna, W and Ames, D and Cobiac, L and Donnan, G and Gibbs, P and Head, R and Krum, H and Jelnik, M and Malik, M and Williamson, J and Eaton, C and Weissfeld, J and MacRae, F and Rodriguez, LM and Newman, AB and Demons, J and Workman, B and Wood, E and Satterfield, S and Ernst, M and Gilbertson, D and Lockery, JE and Hannah, J and Radziszewska, B and Thomas, A and Gill, G and Jackson, C and Kidd, M and Russell, G and Pressman, G and Figueredo, V and Oberoi, M and Ahmad, M and Krstevska, S and Lawson, C and Katzman, S and Powell, J and Lang, M and Bolin, P and Atlanta, VA and Le, A and Johnson, T and Kruger, D and Obisesan, T and Allard, J and Dodd, K and Ott, B and Pemu, P and Hadley, E and Romashkan, SV and Palaniappan, L and Jose, P and Church, T and Myers, V and Monce, R and Britt, N and Gupta, A and Keller, J and Lewis, B and Shikany, J and Allman, R and Anton, S and Pahor, M and Burns, J and Swerdlow, R and Anderson, H and Wiggins, J and Nyquist, L and Peterson, KA and Tindle, H and Johnson, KC and Womack, C and Birnbaum, L and Nesbitt, S and Volpi, E and Flack, J and Ference, B and Singh, M and Lichtenberg, P and Aloia, J and Mikhail, M and Anwarrulah, AA and Trevaks, RE and Fitzgerald, SM and Stocks, N, Study design of ASPirin in Reducing Events in the Elderly (ASPREE): A randomized, controlled trial, Contemporary Clinical Trials, 36, (2) pp. 555-564. ISSN 1551-7144 (2013) [Refereed Article]

Copyright Statement

Copyright 2013 Elsevier Inc.

DOI: doi:10.1016/j.cct.2013.09.014


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.

Item Details

Item Type:Refereed Article
Keywords:Aspirin, Clinical trial, Aging, Dementia, Disability, Primary prevention
Research Division:Biomedical and Clinical Sciences
Research Group:Cardiovascular medicine and haematology
Research Field:Cardiology (incl. cardiovascular diseases)
Objective Division:Health
Objective Group:Clinical health
Objective Field:Clinical health not elsewhere classified
UTAS Author:Nelson, MR (Professor Mark Nelson)
ID Code:87705
Year Published:2013
Web of Science® Times Cited:160
Deposited By:Menzies Institute for Medical Research
Deposited On:2013-12-03
Last Modified:2014-06-18

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