Aspirin in Reducing Events in the Elderly (ASPREE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01038583|
Recruitment Status : Active, not recruiting
First Posted : December 24, 2009
Last Update Posted : April 5, 2021
|Condition or disease||Intervention/treatment|
|Functional Disability Dementia Heart Disease Stroke Cancer Bleeding Depression||Drug: 100 mg enteric-coated aspirin Drug: Placebo|
ASPREE (ASPirin in Reducing Events in the Elderly) is a joint US/Australian research project aiming to determine whether low-dose aspirin increases healthy life-span, defined as survival free of dementia and disability. ASPREE began in 2010 and completed recruitment in 2014. It is a randomized, double-blind, placebo-controlled, primary prevention trial of daily 100 mg of aspirin in a population of healthy older people in the United States (US) and Australia with a period of treatment averaging 4.5 years. ASPREE's primary outcome is length of survival free of dementia and disability and has secondary outcomes encompassing the major health issues related to aging. The trial involving 19,114 persons aged 70 and above (65 years and above for US minorities) is distinctive for its large size, methodological rigor and high participant retention rate in both countries.
ASPREE UNIQUE ASPECTS:
- It is the first large scale trial to incorporate dementia-free and disability-free survival as a primary outcome. This is now recognized as an appropriate goal of treatment in a primary prevention population of this age group. Within a clinical trial context disability-free survival incorporates an estimate of the overall benefits and risks of aspirin in a single outcome measure.
- It is one of the first primary prevention trials of aspirin to include cancer incidence, metastases or mortality as a pre-specified endpoint. Recent meta-analyses [Rothwell et al 2010, 2011, 2012] suggests that aspirin has a significant chemopreventive effect becoming evident after a period of 4+ years of aspirin treatment, but questions remain about the magnitude of benefit, and whether it applies to treatment of all cancers and to older people.
- It will provide information about the impact of aspirin on a range of other conditions (e.g, dementia, CVD, stroke, depression, bleeding) where aspirin has been claimed to have benefit (or risks).
The intervention phase of the trial ended in June 2017 after the NIA determined that it was highly unlikely that aspirin would show a benefit on the overall primary outcome within the planned 5-year time frame. The study is now entering a data cleaning and analysis phase and it is anticipated that the primary results were published in September 2018.
|Study Type :||Observational|
|Actual Enrollment :||19114 participants|
|Official Title:||Aspirin in Reducing Events in the Elderly|
|Actual Study Start Date :||January 2010|
|Actual Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||April 2024|
100 mg enteric-coated aspirin
Drug: 100 mg enteric-coated aspirin
100 mg enteric-coated aspirin, taken daily
100 mg enteric-coated placebo
- The primary endpoint is death from any cause or incident, dementia or persistent physical disability. [ Time Frame: every 6 months ]Dementia will be diagnosed based on DSM-IV criteria. Significant physical disability will be defined as a confirmed, and persisting for at least 6 months, self-report of 'a lot of difficulty', or 'inability to perform independently' any one of the 6 Katz basic Activities of Daily Living (ADLs).75
- All-cause mortality [ Time Frame: every 6 months ]
- Fatal and non fatal cardiovascular events including a) coronary heart disease death, b) non-fatal MI, c) fatal and non-fatal stroke and d) any hospitalization for heart failure [ Time Frame: every 6 months ]
- Fatal and non-fatal cancer, excluding non-melanoma skin cancer [ Time Frame: every 6 months ]
- Dementia [ Time Frame: every 6 months ]
- Mild Cognitive Impairment (MCI; assessed using the Modified Mini-Mental State Examination or 3MS 70 and other cognitive function measures - see below) [ Time Frame: every 6 months ]
- Physical disability [ Time Frame: every 6 months ]
- Major hemorrhagic events [ Time Frame: every 6 months ]
- Depression [ Time Frame: Annually ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038583
|Principal Investigator:||Anne Murray, MD, MSc||Berman Center for Outcomes and Clinical Research|
|Principal Investigator:||John McNeil, MBBS, PHD||Monash University|