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


ASPREE Investigator Group,


Contemporary Clinical Trials, Volume: 36, No.: 2, Pages.: 555-564

Year of Publication



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.; © 2013. Published by Elsevier Inc. All rights reserved.

Bibtex Citation

@article{2013, doi = {10.1016/j.cct.2013.09.014}, url = {}, year = 2013, month = {nov}, publisher = {Elsevier {BV}}, volume = {36}, number = {2}, pages = {555--564}, title = {Study design of {ASPirin} in Reducing Events in the Elderly ({ASPREE}): A randomized, controlled trial}, journal = {Contemporary Clinical Trials} }


activities of daily living, administration & dosage, adverse effects, aged, aging, antiinflammatory agents nonsteroidal, aspirin, australia, cardiovascular diseases, chemically induced, clinical trial, dementia, depression, disability, disabled persons, doubleblind method, female, gastrointestinal hemorrhage, humans, male, mild cognitive impairment, mortality, neoplasms, prevention & control, primary prevention, risk assessment, statistics & numerical data, tablets entericcoated, therapeutic use, united states

Countries of Study

Australia, USA

Types of Study

Randomised Controlled Trial

Type of Outcomes

Cognition, Depression and Anxiety


Primary Care

Type of Interventions

Risk Factor Modification

Risk Factor Modifications

General population health promotion