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Study design of ASPirin in reducing events in the elderly (ASPREE): a randomized, controlled trial

Grimm, RH, McNeil, JJ, Applegate, W, Beilin, L, Espinoza, S, Johnston, C, Kirpach, B, Margolis, K, Murray, A, Nelson, MR, Reid, CM, Shah, R, Storey, E, Tonkin, AM, Wilson, P, Wolfe, Rachel, Woods, RL, Abhayaratna, W, Ames, D, Cobiac, L, Donnan, G, Gibbs, P, Head, R, Krum, H, Ives, D, Jelnik, M, Malik, M, Williamson, J, Eaton, C, Weissfeld, J, MacRae, F, Rodriguez, LM, Newman, A, Demons, J, Workman, B, Wood, E, Satterfield, S, Ernst, M, Gilbertson, D, Lockery, JE, Hannah, J, Radziszewska, B, Thomas, A, Gill, Gerard, Jackson, C, Kidd, M and Russell, G 2013, Study design of ASPirin in reducing events in the elderly (ASPREE): a randomized, controlled trial, Contemporary clinical trials, vol. 36, no. 2, pp. 555-564, doi: 10.1016/j.cct.2013.09.014.

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Title Study design of ASPirin in reducing events in the elderly (ASPREE): a randomized, controlled trial
Author(s) Grimm, RH
McNeil, JJ
Applegate, W
Beilin, L
Espinoza, S
Johnston, C
Kirpach, B
Margolis, K
Murray, A
Nelson, MR
Reid, CM
Shah, R
Storey, E
Tonkin, AM
Wilson, P
Wolfe, Rachel
Woods, RL
Abhayaratna, W
Ames, D
Cobiac, L
Donnan, G
Gibbs, P
Head, R
Krum, H
Ives, D
Jelnik, M
Malik, M
Williamson, J
Eaton, C
Weissfeld, J
MacRae, F
Rodriguez, LM
Newman, A
Demons, J
Workman, B
Wood, E
Satterfield, S
Ernst, M
Gilbertson, D
Lockery, JE
Hannah, J
Radziszewska, B
Thomas, A
Gill, GerardORCID iD for Gill, Gerard orcid.org/0000-0003-1381-7426
Jackson, C
Kidd, M
Russell, G
Journal name Contemporary clinical trials
Volume number 36
Issue number 2
Start page 555
End page 564
Total pages 10
Publisher Elzevier
Place of publication Amsterdam, The Netherlands
Publication date 2013-11
ISSN 1551-7144
1559-2030
Keyword(s) Science & Technology
Life Sciences & Biomedicine
Medicine, Research & Experimental
Pharmacology & Pharmacy
Research & Experimental Medicine
Aspirin
Clinical trial
Aging
Dementia
Disability
Primary prevention
LOW-DOSE ASPIRIN
ALZHEIMER-DISEASE
CLINICAL-TRIALS
AFRICAN-AMERICANS
RISK
ASSOCIATION
RELIABILITY
PEOPLE
Summary 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.
Language eng
DOI 10.1016/j.cct.2013.09.014
Field of Research 110201 Cardiology (incl Cardiovascular Diseases)
111502 Clinical Pharmacology and Therapeutics
111716 Preventive Medicine
11 Medical And Health Sciences
Socio Economic Objective 920502 Health Related to Ageing
HERDC Research category C1.1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2013, Elsevier Inc.
Persistent URL http://hdl.handle.net/10536/DRO/DU:30068975

Document type: Journal Article
Collection: School of Medicine
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