Study design of ASPirin in Reducing Events in the Elderly (ASPREE): A randomized, controlled trial
Autor: | E. Volpi, S. Katzman, A. A. Anwarrulah, B. Lewis, C. Womack, P. Wilson, Erica M. Wood, E. Hadley, J. Keller, M. Kidd, K. Dodd, Sharyn M. Fitzgerald, B. Ference, W. B. Applegate, Shawna D. Nesbitt, Walter P. Abhayaratna, S. V. Romashkan, M. Lang, V. A. Atlanta, Gerard Gill, J. Powell, T. Obisesan, Latha Palaniappan, M. Malik, A. Le, R. Swerdlow, C. Eaton, David Ames, J. Burns, H. Anderson, Elsdon Storey, Jessica E. Lockery, C. I. Johnston, Mark Nelson, J. Hannah, R. Head, Geoffrey A. Donnan, P. Bolin, T. Johnson, Andrew Tonkin, A. Newman, Christopher M. Reid, R. C. Shah, G. Pressman, A. Thomas, S. Satterfield, J. Weissfeld, Kevin A. Peterson, B. Radziszewska, J. Williamson, D. Gilbertson, John J McNeil, J. Flack, Jamehl S. Demons, K. Margolis, Nigel Stocks, Priscilla Pemu, J. Allard, James M. Shikany, Barbara Workman, L. Beilin, M. Singh, S. Anton, V. Figueredo, Peter Gibbs, P. Lichtenberg, Marco Pahor, M. Ernst, M. Ahmad, C. Jackson, Rory Wolfe, Sara E. Espinoza, M. Mikhail, F. MacRae, H. Krum, L. Cobiac, Lee A Birnbaum, J. Wiggins, V. Myers, W. Applegate, Nathan E. Britt, S. Krstevska, A. B. Newman, M. Oberoi, G. Russell, A. Gupta, D. Kruger, Robyn L. Woods, T. Church, R. E. Trevaks, B. Kirpach, Anne M Murray, R. Shah, Ron Monce, H. Tindle, M. Jelnik, L. M. Rodriguez, J. Aloia, B. Ott, L. Nyquist, R. Grimm, K. C. Johnson, C. Lawson, R. Allman, P. Jose |
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Rok vydání: | 2013 |
Předmět: |
Male
medicine.medical_specialty Activities of daily living Physical disability Risk Assessment Article law.invention Double-Blind Method Randomized controlled trial law Neoplasms Internal medicine Activities of Daily Living medicine Clinical endpoint Humans Dementia Cognitive Dysfunction Disabled Persons Pharmacology (medical) Mortality Depression (differential diagnoses) Aged Aspirin Depression business.industry Anti-Inflammatory Agents Non-Steroidal Australia General Medicine medicine.disease United States Clinical trial Cardiovascular Diseases Physical therapy Female Tablets Enteric-Coated Gastrointestinal Hemorrhage business medicine.drug |
Zdroj: | Contemporary Clinical Trials. 36:555-564 |
ISSN: | 1551-7144 |
DOI: | 10.1016/j.cct.2013.09.014 |
Popis: | 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. |
Databáze: | OpenAIRE |
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