Study design of ASPirin in Reducing Events in the Elderly (ASPREE): A randomized, controlled trial
Open accessAbstract
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 100mg 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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The ASPREE trial is a novel approach to assessing the utility of platelet medication in senior adults; its primary end point is disability-free life, including dementia and persistent disability, rather than thromboembolic events, bleeding, and traditional metrics.
“The ASPREE trial (Aspirin in Reducing Events in the Elderly) stands out as a novel approach to assessing the utility of platelet medication in senior adults.48 Instead of measuring thromboembolic events, bleeding, and the traditional metrics that one might expect, the primary end point is disability-free life, including dementia and persistent disability.”
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- Authors
- ASPREE Investigator Group
- Corresponding author
- ASPREE Investigator Group
- Venue
- Contemporary Clinical Trials
- Publisher
- Elsevier BV
- Published
- 2013-11
- Volume
- 36
- Issue
- 2
- Pages
- 555-564
- ISSN
- 1551-7144 (ISSN-L)
- PMC
- PMC3919683
- OpenAlex
- W1533850659
- Cited by
- 310
- References
- 45
- Citations by year
- 2026: 26 · 2025: 41 · 2024: 31 · 2023: 39 · 2022: 29 · 2021: 27 · 2020: 30 · 2019: 9 · 2018: 18 · 2017: 26 · 2016: 20 · 2015: 11 · 2014: 1 · 2013: 1 · 2012: 1
- FWCI
- 7.47
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Contemporary Clinical Trials (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- eCite Digital Repository (University of Tasmania) (submittedVersion)
- UWA Profiles and Research Repository (UWA) (submittedVersion)
- Adelaide Research & Scholarship (AR&S) (University of Adelaide) (submittedVersion)
- eSpace (Curtin University) (submittedVersion)
- Figshare (submittedVersion, cc-by)
- Lirias (KU Leuven) (submittedVersion)
- ANU Open Research (Australian National University) (submittedVersion)
- Funders
- Medical Research Council
- National Health and Medical Research Council
- National Institute on Aging (U01AG029824, P30AG028740, P30AG024832, P30AG044271)
- National Cancer Institute
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
- Health Sciences › Medicine › Pharmacology › Inflammatory mediators and NSAID effects
- Health Sciences › Medicine › Geriatrics and Gerontology › Pharmaceutical Practices and Patient Outcomes
- Keywords
- low-dose aspirin, primary prevention, older adults, dementia, mortality, cardiovascular events, cancer, bleeding risk, activities of daily living, healthy aging
- MeSH terms
- Activities of Daily Living, Aged, Anti-Inflammatory Agents, Non-Steroidal, Aspirin, Australia, Cardiovascular Diseases, Dementia, Depression, Double-Blind Method, Female, Persons with Disabilities, Gastrointestinal Hemorrhage, Humans, Male, Mortality, Neoplasms, Tablets, Enteric-Coated, United States, Risk Assessment, Cognitive Dysfunction
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