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

the ASPREE Investigator Group

Research output: Contribution to journalArticleResearchpeer-review

84 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

Cite this

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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.",
author = "Richard Grimm and McNeil, {John James} and Applegate, {William B} and Lawrie Beilin and Espinoza, {Sara E} and Johnston, {Colin Ivor} and Kirpach, {Brenda R} and Margolis, {Karen L} and Murray, {Anne M} and Mark Nelson and Reid, {Christopher Michael} and Reena Shah and Elsdon Storey and Tonkin, {Andrew Maxwell} and Wilson, {Peter W F} and Wolfe, {Rory St John} and Woods, {Robyn Lorraine} and Walter Abhayaratna and Ames, {David A} and Lynne Cobiac and Geoffrey Donnan and Peter Gibbs and Head, {Rachel Baublet} and Henry Krum and Ives, {Diane G} and Michael Jelinek and Malik, {Mobin A} and Williamson, {Jeff D} and Eaton, {Charles B} and Weissfeld, {Joel L} and Macrae, {Finlay A} and Rodriguez, {Luisa M} and Newman, {Anne B} and Demons, {Jamehl L} and Barbara Workman and Wood, {Erica Michelle} and Satterfield, {Suzanne A} and Ernst, {Michael E} and Gilbertson, {David T} and Jessica Lockery and Judy Hannah and Barbara Radziszewska and Thomas, {Adrian P} and Gerard Gill and Jackson, {Christine H} and M Kidd and Russell, {Garth S} and Gregg Pressman and Figueredo, {Vincent M} and Oberoi, {Mandeep S} and Mayraj Ahmad and Krstevska, {Shana S} and Lawson, {Carl J} and Shana Katzman and Powell, {Judy L} and Lang, {Michael C} and Paul Bolin and A Le and Theodore Johnson and Kruger, {Davida F} and Thomas Obisesan and Allard, {Jacques F} and Dodd, {Katherine S} and Ott, {Brian R} and Pemu, {Priscilla E} and Hadley, {Evan C} and Romashkan, {Sergei V} and Palaniappan, {Latha P} and Jose, {Powell O} and Church, {Timothy S} and Valerie Myers and Roland Monce and Nathan Britt and Gupta, {Alok K} and Keller, {Jeffrey N} and Lewis, {Bobby R} and Shikany, {James M} and Richard Allman and Stephen Anton and Marco Pahor and George Bergus and Burns, {Jeffrey M} and Swerdlow, {Russell Howard} and H Anderson and Jocelyn Wiggins and Linda Nyquist and Peterson, {Kevin A} and Tindle, {Hilary Aurora} and Johnson, {Karen Chandler} and Womack, {Catherine R} and Lee Birnbaum and Shawna Nesbitt and Elena Volpi and Flack, {John M} and Ference, {Brian A} and Singh, {Manmeet M} and Lichtenberg, {Peter A} and Aloia, {John F} and Mageda Mikhail and Anwarullah, {Ayesha A} and Hannan, {Ruth Elizabeth} and Fitzgerald, {Sharyn Margaret} and Nigel Stocks and {the ASPREE Investigator Group}",
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language = "English",
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Study design of ASPirin in Reducing Events in the Elderly (ASPREE): A randomized, controlled trial. / the ASPREE Investigator Group.

In: Contemporary Clinical Trials, Vol. 36, No. 2, 2013, p. 555-564.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Study design of ASPirin in Reducing Events in the Elderly (ASPREE): A randomized, controlled trial

AU - Grimm, Richard

AU - McNeil, John James

AU - Applegate, William B

AU - Beilin, Lawrie

AU - Espinoza, Sara E

AU - Johnston, Colin Ivor

AU - Kirpach, Brenda R

AU - Margolis, Karen L

AU - Murray, Anne M

AU - Nelson, Mark

AU - Reid, Christopher Michael

AU - Shah, Reena

AU - Storey, Elsdon

AU - Tonkin, Andrew Maxwell

AU - Wilson, Peter W F

AU - Wolfe, Rory St John

AU - Woods, Robyn Lorraine

AU - Abhayaratna, Walter

AU - Ames, David A

AU - Cobiac, Lynne

AU - Donnan, Geoffrey

AU - Gibbs, Peter

AU - Head, Rachel Baublet

AU - Krum, Henry

AU - Ives, Diane G

AU - Jelinek, Michael

AU - Malik, Mobin A

AU - Williamson, Jeff D

AU - Eaton, Charles B

AU - Weissfeld, Joel L

AU - Macrae, Finlay A

AU - Rodriguez, Luisa M

AU - Newman, Anne B

AU - Demons, Jamehl L

AU - Workman, Barbara

AU - Wood, Erica Michelle

AU - Satterfield, Suzanne A

AU - Ernst, Michael E

AU - Gilbertson, David T

AU - Lockery, Jessica

AU - Hannah, Judy

AU - Radziszewska, Barbara

AU - Thomas, Adrian P

AU - Gill, Gerard

AU - Jackson, Christine H

AU - Kidd, M

AU - Russell, Garth S

AU - Pressman, Gregg

AU - Figueredo, Vincent M

AU - Oberoi, Mandeep S

AU - Ahmad, Mayraj

AU - Krstevska, Shana S

AU - Lawson, Carl J

AU - Katzman, Shana

AU - Powell, Judy L

AU - Lang, Michael C

AU - Bolin, Paul

AU - Le, A

AU - Johnson, Theodore

AU - Kruger, Davida F

AU - Obisesan, Thomas

AU - Allard, Jacques F

AU - Dodd, Katherine S

AU - Ott, Brian R

AU - Pemu, Priscilla E

AU - Hadley, Evan C

AU - Romashkan, Sergei V

AU - Palaniappan, Latha P

AU - Jose, Powell O

AU - Church, Timothy S

AU - Myers, Valerie

AU - Monce, Roland

AU - Britt, Nathan

AU - Gupta, Alok K

AU - Keller, Jeffrey N

AU - Lewis, Bobby R

AU - Shikany, James M

AU - Allman, Richard

AU - Anton, Stephen

AU - Pahor, Marco

AU - Bergus, George

AU - Burns, Jeffrey M

AU - Swerdlow, Russell Howard

AU - Anderson, H

AU - Wiggins, Jocelyn

AU - Nyquist, Linda

AU - Peterson, Kevin A

AU - Tindle, Hilary Aurora

AU - Johnson, Karen Chandler

AU - Womack, Catherine R

AU - Birnbaum, Lee

AU - Nesbitt, Shawna

AU - Volpi, Elena

AU - Flack, John M

AU - Ference, Brian A

AU - Singh, Manmeet M

AU - Lichtenberg, Peter A

AU - Aloia, John F

AU - Mikhail, Mageda

AU - Anwarullah, Ayesha A

AU - Hannan, Ruth Elizabeth

AU - Fitzgerald, Sharyn Margaret

AU - Stocks, Nigel

AU - the ASPREE Investigator Group

PY - 2013

Y1 - 2013

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.

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JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

SN - 1551-7144

IS - 2

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