Aspirin in Reducing Events in the Elderly

ASPREE BACKGROUND:

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:

1. 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.

2. 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.

3. 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.

Inclusion Criteria:

- Men and women

- African American and Hispanic persons age 65 or older

- Any person from another ethnic minority group and Caucasian persons age 70 or older

- Willing and able to provide informed consent, and willing to accept the study
requirements

Exclusion Criteria:

- A history of a diagnosed cardiovascular event

- A serious intercurrent illness likely to cause death within the next 5 years, such as
terminal cancer or obstructive airways disease

- A current or recurrent condition with a high risk of major bleeding, ex: cerebral
aneurysm

- Anemia

- Absolute contraindication or allergy to aspirin

- Current participation in a clinical trial

- Current continuous use of aspirin or other anti-platelet drug or anticoagulant for
secondary prevention. People with previous use of aspirin for primary prevention may
enter the trial, provided they agree to cease existing use of aspirin and understand
that they may be subsequently randomly allocated to low dose aspirin or placebo.

- A systolic blood pressure ≥180 mmHg and / or a diastolic blood pressure ≥105 mmHg

- A history of dementia

- Severe difficulty or an inability to perform any one of the 6 Katz ADLs

- Non-compliance to taking pill