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

R. H. Grimm; J. J. McNeil; W. Applegate; L. Beilin; S. Espinoza; C. Johnston; B. Kirpach; K. Margolis; A. Murray; M. R. Nelson; C. M. Reid; R. Shah; E. Storey; A. M. Tonkin; P. Wilson; R. Wolfe; R. L. Woods; W. Abhayaratna; D. Ames; L. Cobiac; G. Donnan; P. Gibbs; R. Head; H. Krum; D. Ives; M. Jelnik; M. Malik; J. Williamson; C. Eaton; J. Weissfeld; F. MacRae; L. M. Rodriguez; A. Newman; J. Demons; B. Workman; E. Wood; S. Satterfield; J. E. Lockery; R. C. Shah; B. Radziszewska; A. Thomas; G. Gill; C. Jackson; M. Kidd; G. Russell; ASPREE Investigator Group; Michael Ernst

doi:10.1016/j.cct.2013.09.014

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

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

R. H. Grimm, J. J. McNeil, W. Applegate, L. Beilin, S. Espinoza, C. Johnston, B. Kirpach, K. Margolis, A. Murray, M. R. Nelson, …

Contemporary clinical trials, Vol.36(2), pp.555-564

11/01/2013

DOI: 10.1016/j.cct.2013.09.014

PMCID: PMC3919683

PMID: 24113028

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https://www.ncbi.nlm.nih.gov/pmc/articles/3919683View

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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. (C) 2013 Elsevier Inc. All rights reserved.

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Title: Subtitle: Study design of ASPirin in Reducing Events in the Elderly (ASPREE): A randomized, controlled trial
Creators: R. H. Grimm
J. J. McNeil
W. Applegate
L. Beilin
S. Espinoza
C. Johnston
B. Kirpach
K. Margolis
A. Murray
M. R. Nelson
C. M. Reid
R. Shah
E. Storey
A. M. Tonkin
P. Wilson
R. Wolfe
R. L. Woods
W. Abhayaratna
D. Ames
L. Cobiac
G. Donnan
P. Gibbs
R. Head
H. Krum
D. Ives
M. Jelnik
M. Malik
J. Williamson
C. Eaton
J. Weissfeld
F. MacRae
L. M. Rodriguez
A. Newman
J. Demons
B. Workman
E. Wood
S. Satterfield
J. E. Lockery
R. C. Shah
B. Radziszewska
A. Thomas
G. Gill
C. Jackson
M. Kidd
G. Russell
ASPREE Investigator Group
Michael Ernst (Contributor) - University of Iowa, Pharmacy Practice and Science
Resource Type: Journal article
Publication Details: Contemporary clinical trials, Vol.36(2), pp.555-564
DOI: 10.1016/j.cct.2013.09.014
PMID: 24113028
PMCID: PMC3919683
NLM abbreviation: Contemp Clin Trials
ISSN: 1551-7144
eISSN: 1559-2030
Publisher: Elsevier
Number of pages: 10
Grant note: Heart Foundation (Australia) National Health and Medical Research Council (Australia); National Health and Medical Research Council (NHMRC) of Australia P30AG028740; P30AG024832; U01AG029824 / NATIONAL INSTITUTE ON AGING; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute on Aging (NIA) National Cancer Institute; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Cancer Institute (NCI) National Institute on Aging; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute on Aging (NIA) Victorian Cancer Agency (Australia)
Language: English
Date published: 11/01/2013
Academic Unit: Family and Community Medicine; Pharmacy Practice and Science
Record Identifier: 9984297339402771

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