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

R. Grimm; J. J. McNeil; W. Applegate; L. Beilin; S. Espinoza; C. I. 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; M. Jelnik; M. Malik; J. Williamson; C. Eaton; J. Weissfeld; F. MacRae; L. M. Rodriguez; R. Shah; A. Newman; J. Demons; B. Workman; E. Wood; S. Satterfield; M. Ernst; D. Gilbertson; J. E. Lockery; R. C. Shah; M. Ernst; J. Hannah; A. Newman; B. Radziszewska; R. Shah; A. Thomas; G. Gill; C. Jackson; M. Kidd; G. Russell; G. Pressman; V. Figueredo; M. Oberoi; M. Ahmad; S. Krstevska; C. Lawson; S. Katzman; J. Powell; M. Lang; P. Bolin; V. A. Atlanta; A. Le; T. Johnson; A. Thomas; D. Kruger; T. Obisesan; J. Allard; K. Dodd; B. Ott; P. Pemu; B. Radziszewska; E. Hadley; S. V. Romashkan; L. Palaniappan; P. Jose; T. Church; V. Myers; R. Monce; N. Britt; A. Gupta; J. Keller; R. C. Shah; B. Lewis; J. Shikany; R. Allman; S. Anton; M. Pahor; J. Burns; R. Swerdlow; H. Anderson; J. Wiggins; L. Nyquist; K. A. Peterson; A. B. Newman; H. Tindle; K. C. Johnson; C. Womack; L. Birnbaum; S. Nesbitt; E. Volpi; W. B. Applegate; J. Flack; B. Ference; M. Singh; P. Lichtenberg; J. Aloia; M. Mikhail; A. A. Anwarrulah; R. E. Trevaks; S. M. Fitzgerald; N. Stocks

doi:10.1016/j.cct.2013.09.014

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

R. Grimm, J. J. McNeil, W. Applegate, L. Beilin, S. Espinoza, C. I. 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. CobiacG. Donnan, P. Gibbs, R. Head, H. Krum, M. Jelnik, M. Malik, J. Williamson, C. Eaton, J. Weissfeld, F. MacRae, L. M. Rodriguez, R. Shah, A. Newman, J. Demons, B. Workman, E. Wood, S. Satterfield, M. Ernst, D. Gilbertson, J. E. Lockery, R. C. Shah, M. Ernst, J. Hannah, A. Newman, B. Radziszewska, R. Shah, A. Thomas, G. Gill, C. Jackson, M. Kidd, G. Russell, G. Pressman, V. Figueredo, M. Oberoi, M. Ahmad, S. Krstevska, C. Lawson, S. Katzman, J. Powell, M. Lang, P. Bolin, V. A. Atlanta, A. Le, T. Johnson, A. Thomas, D. Kruger, T. Obisesan, J. Allard, K. Dodd, B. Ott, P. Pemu, B. Radziszewska, E. Hadley, S. V. Romashkan, L. Palaniappan, P. Jose, T. Church, V. Myers, R. Monce, N. Britt, A. Gupta, J. Keller, R. C. Shah, B. Lewis, J. Shikany, R. Allman, S. Anton, M. Pahor, J. Burns, R. Swerdlow, H. Anderson, J. Wiggins, L. Nyquist, K. A. Peterson, A. B. Newman, H. Tindle, K. C. Johnson, C. Womack, L. Birnbaum, S. Nesbitt, E. Volpi, W. B. Applegate, J. Flack, B. Ference, M. Singh, P. Lichtenberg, J. Aloia, M. Mikhail, A. A. Anwarrulah, R. E. Trevaks, S. M. Fitzgerald, N. Stocks

Research output: Contribution to journal › Article › peer-review

208 Scopus citations

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 language	English (US)
Pages (from-to)	555-564
Number of pages	10
Journal	Contemporary Clinical Trials
Volume	36
Issue number	2
DOIs	https://doi.org/10.1016/j.cct.2013.09.014
State	Published - Nov 1 2013

Keywords

Aging
Aspirin
Clinical trial
Dementia
Disability
Primary prevention

ASJC Scopus subject areas

Pharmacology (medical)

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10.1016/j.cct.2013.09.014

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Grimm, R., McNeil, J. J., Applegate, W., Beilin, L., Espinoza, S., Johnston, C. I., Kirpach, B., Margolis, K., Murray, A., Nelson, M. R., Reid, C. M., Shah, R., Storey, E., Tonkin, A. M., Wilson, P., Wolfe, R., Woods, R. L., 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

Grimm, R, McNeil, JJ, Applegate, W, Beilin, L, Espinoza, S, Johnston, CI, Kirpach, B, Margolis, K, Murray, A, Nelson, MR, Reid, CM, Shah, R, Storey, E, Tonkin, AM, Wilson, P, Wolfe, R, Woods, RL, Abhayaratna, W, Ames, D, Cobiac, L, Donnan, G, Gibbs, P, Head, R, Krum, H, Jelnik, M, Malik, M, Williamson, J, Eaton, C, Weissfeld, J, MacRae, F, Rodriguez, LM, Shah, R, Newman, A, Demons, J, Workman, B, Wood, E, Satterfield, S, Ernst, M, Gilbertson, D, Lockery, JE, Shah, RC, Ernst, M, Hannah, J, Newman, A, Radziszewska, B, Shah, R, Thomas, A, Gill, G, Jackson, C, Kidd, M, Russell, G, Pressman, G, Figueredo, V, Oberoi, M, Ahmad, M, Krstevska, S, Lawson, C, Katzman, S, Powell, J, Lang, M, Bolin, P, Atlanta, VA, Le, A, Johnson, T, Thomas, A, Kruger, D, Obisesan, T, Allard, J, Dodd, K, Ott, B, Pemu, P, Radziszewska, B, Hadley, E, Romashkan, SV, Palaniappan, L, Jose, P, Church, T, Myers, V, Monce, R, Britt, N, Gupta, A, Keller, J, Shah, RC, Lewis, B, Shikany, J, Allman, R, Anton, S, Pahor, M, Burns, J, Swerdlow, R, Anderson, H, Wiggins, J, Nyquist, L, Peterson, KA, Newman, AB, Tindle, H, Johnson, KC, Womack, C, Birnbaum, L, Nesbitt, S, Volpi, E, Applegate, WB, Flack, J, Ference, B, Singh, M, Lichtenberg, P, Aloia, J, Mikhail, M, Anwarrulah, AA, Trevaks, RE, Fitzgerald, SM & Stocks, N 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. https://doi.org/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",

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.",

keywords = "Aging, Aspirin, Clinical trial, Dementia, Disability, Primary prevention",

author = "R. Grimm and McNeil, {J. J.} and W. Applegate and L. Beilin and S. Espinoza and Johnston, {C. I.} and B. Kirpach and K. Margolis and A. Murray and Nelson, {M. R.} and Reid, {C. M.} and R. Shah and E. Storey and Tonkin, {A. M.} and P. Wilson and R. Wolfe and Woods, {R. L.} and W. Abhayaratna and D. Ames and L. Cobiac and G. Donnan and P. Gibbs and R. Head and H. Krum and M. Jelnik and M. Malik and J. Williamson and C. Eaton and J. Weissfeld and F. MacRae and Rodriguez, {L. M.} and R. Shah and A. Newman and J. Demons and B. Workman and E. Wood and S. Satterfield and M. Ernst and D. Gilbertson and Lockery, {J. E.} and Shah, {R. C.} and M. Ernst and J. Hannah and A. Newman and B. Radziszewska and R. Shah and A. Thomas and G. Gill and C. Jackson and M. Kidd and G. Russell and G. Pressman and V. Figueredo and M. Oberoi and M. Ahmad and S. Krstevska and C. Lawson and S. Katzman and J. Powell and M. Lang and P. Bolin and Atlanta, {V. A.} and A. Le and T. Johnson and A. Thomas and D. Kruger and T. Obisesan and J. Allard and K. Dodd and B. Ott and P. Pemu and B. Radziszewska and E. Hadley and Romashkan, {S. V.} and L. Palaniappan and P. Jose and T. Church and V. Myers and R. Monce and N. Britt and A. Gupta and J. Keller and Shah, {R. C.} and B. Lewis and J. Shikany and R. Allman and S. Anton and M. Pahor and J. Burns and R. Swerdlow and H. Anderson and J. Wiggins and L. Nyquist and Peterson, {K. A.} and Newman, {A. B.} and H. Tindle and Johnson, {K. C.} and C. Womack and L. Birnbaum and S. Nesbitt and E. Volpi and Applegate, {W. B.} and J. Flack and B. Ference and M. Singh and P. Lichtenberg and J. Aloia and M. Mikhail and Anwarrulah, {A. A.} and Trevaks, {R. E.} and Fitzgerald, {S. M.} and N. Stocks",

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doi = "10.1016/j.cct.2013.09.014",

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T1 - Study design of ASPirin in Reducing Events in the Elderly (ASPREE)

T2 - A randomized, controlled trial

AU - Grimm, R.

AU - McNeil, J. J.

AU - Applegate, W.

AU - Beilin, L.

AU - Espinoza, S.

AU - Johnston, C. I.

AU - Kirpach, B.

AU - Margolis, K.

AU - Murray, A.

AU - Nelson, M. R.

AU - Reid, C. M.

AU - Shah, R.

AU - Storey, E.

AU - Tonkin, A. M.

AU - Wilson, P.

AU - Wolfe, R.

AU - Woods, R. L.

AU - Abhayaratna, W.

AU - Ames, D.

AU - Cobiac, L.

AU - Donnan, G.

AU - Gibbs, P.

AU - Head, R.

AU - Krum, H.

AU - Jelnik, M.

AU - Malik, M.

AU - Williamson, J.

AU - Eaton, C.

AU - Weissfeld, J.

AU - MacRae, F.

AU - Rodriguez, L. M.

AU - Shah, R.

AU - Newman, A.

AU - Demons, J.

AU - Workman, B.

AU - Wood, E.

AU - Satterfield, S.

AU - Ernst, M.

AU - Gilbertson, D.

AU - Lockery, J. E.

AU - Shah, R. C.

AU - Ernst, M.

AU - Hannah, J.

AU - Newman, A.

AU - Radziszewska, B.

AU - Shah, R.

AU - Thomas, A.

AU - Gill, G.

AU - Jackson, C.

AU - Kidd, M.

AU - Russell, G.

AU - Pressman, G.

AU - Figueredo, V.

AU - Oberoi, M.

AU - Ahmad, M.

AU - Krstevska, S.

AU - Lawson, C.

AU - Katzman, S.

AU - Powell, J.

AU - Lang, M.

AU - Bolin, P.

AU - Atlanta, V. A.

AU - Le, A.

AU - Johnson, T.

AU - Thomas, A.

AU - Kruger, D.

AU - Obisesan, T.

AU - Allard, J.

AU - Dodd, K.

AU - Ott, B.

AU - Pemu, P.

AU - Radziszewska, B.

AU - Hadley, E.

AU - Romashkan, S. V.

AU - Palaniappan, L.

AU - Jose, P.

AU - Church, T.

AU - Myers, V.

AU - Monce, R.

AU - Britt, N.

AU - Gupta, A.

AU - Keller, J.

AU - Shah, R. C.

AU - Lewis, B.

AU - Shikany, J.

AU - Allman, R.

AU - Anton, S.

AU - Pahor, M.

AU - Burns, J.

AU - Swerdlow, R.

AU - Anderson, H.

AU - Wiggins, J.

AU - Nyquist, L.

AU - Peterson, K. A.

AU - Newman, A. B.

AU - Tindle, H.

AU - Johnson, K. C.

AU - Womack, C.

AU - Birnbaum, L.

AU - Nesbitt, S.

AU - Volpi, E.

AU - Applegate, W. B.

AU - Flack, J.

AU - Ference, B.

AU - Singh, M.

AU - Lichtenberg, P.

AU - Aloia, J.

AU - Mikhail, M.

AU - Anwarrulah, A. A.

AU - Trevaks, R. E.

AU - Fitzgerald, S. M.

AU - Stocks, N.

PY - 2013/11/1

Y1 - 2013/11/1

N2 - 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.

AB - 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.

KW - Aging

KW - Aspirin

KW - Clinical trial

KW - Dementia

KW - Disability

KW - Primary prevention

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ER -

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

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