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

Richard Grimm, John McNeil, William Applegate, Lawrence Beilin, S Espinoza, Colin Johnston, Brenda Kirpach, Karen Margolis, Anne-Marie Murray, Mark Nelson, Christopher Reid, Reena Shah, Elsdon Storey, Andrew Tonkin, Peggy Wilson, Rory Wolfe, Robyn Woods, Walter Abhayaratna, D Ames, Lynne CobiacG Donnan, Peter Gibbs, Rachel Head, Henry Krum, M Jelnik, Mobin Malik, Jeff Williamson, Charles Eaton, Joel Weissfeld, Finlay Macrae, Luisa Rodriguez, Raj Shah, Anne Newman, Jamehl Demons, Barbara Workman, Erica Wood, Suzanne Satterfield, Michael Ernst, David Gilbertson, J Lockery, Rehan Shah, Monika Ernst, J Hannah, Alisha Newman, Barbara Radziszewska, Rashmee Shah, Adrian Thomas, Gerard Gill, Christine Jackson, M Kidd, Garth Russell, G Pressman, Vincent Figueredo, M Oberoi, Mukhtar Ahmad, Shana Krstevska, Carl Lawson, Shana Katzman, Judy Powell, M Lang, Paula Bolin, V Atlanta, A Le, Tony Johnson, Abraham Thomas, Dawie Kruger, Thomas Obisesan, Jacques Allard, Katherine Dodd, Brian Ott, Priscilla Pemu, Evan Hadley, Sergei Romashkan, Latha Palaniappan, Powell Jose, Timothy Church, Vicki Myers, R Monce, N Britt, Anil Gupta, John Keller, Ruta Shah, Benjamin Lewis, James Shikany, R Allman, Susan Anton, Marco Pahor, Jeffrey Burns, Russell Swerdlow, Hugh Anderson, John Wiggins, Linda Nyquist, Kari Peterson, Hilary Tindle, Karen Johnson, Catherine Womack, Linda Birnbaum, Steven Nesbitt, Elisabetta Volpi, Jeff Flack, B Ference, Mukesh Singh, P Lichtenberg, John Aloia, Mageda Mikhail, A Anwarrulah, R Trevaks, Sharyn Fitzgerald, Nigel Stocks

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    105 Citations (Scopus)

    Abstract

    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.

    Original languageEnglish
    Pages (from-to)555-564
    Number of pages10
    JournalContemporary Clinical Trials
    Volume36
    Issue number2
    DOIs
    Publication statusPublished - 2013

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    Grimm, R., McNeil, J., Applegate, W., Beilin, L., Espinoza, S., Johnston, C., Kirpach, B., Margolis, K., Murray, A-M., Nelson, M., Reid, C., Shah, R., Storey, E., Tonkin, A., Wilson, P., Wolfe, R., Woods, R., Abhayaratna, W., Ames, D., ... Stocks, N. (2013). Study design of ASPirin in Reducing Events in the Elderly (ASPREE): A randomized, controlled trial. Contemporary Clinical Trials, 36(2), 555-564. https://doi.org/10.1016/j.cct.2013.09.014