Aspirin in Reducing Events in the Elderly-Extension (ASPREE-XT)

ASPREE-XT is a post-treatment, longitudinal observational follow-up study of ASPREE participants. Although the ASPREE trial medication was ceased, the study activity was not stopped and ASPREE participants are continuing with scheduled visits and phone calls. An observational follow-up phase (ASPREE-XT), began in January, 2018. This will enable the monitoring of possible delayed effects of aspirin treatment, primarily on cancer incidence, metastases and mortality. In addition to monitoring the incidence of malignancy within the ASPREE cohort, the opportunity will be taken to observe any other residual effects of aspirin on the endpoints being monitored in the cohort. Continuity of contact with study participants is the key to retention of the cohort for any ongoing or future studies.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Functional Disability Behavior Behavioral Symptoms Bleeding Brain Diseases Cancer Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dementia Depression Frailty Heart Disease Heart Diseases Hemorrhage Mental Disorders Neoplasms Nervous System Diseases Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Trials Unit, The Canberra Hospital, Garran, Australian Capital Territory, Australia

About this study

ASPREE-XT is a longitudinal, observational follow-on study of ASPREE participants.

The methodology of ASPREE-XT is based closely on ASPREE [ASPREE investigator group, 2013; www.aspree.org; McNeil et al. 2017]. Clinical, neurocognitive and physical function measurements, questionnaires for mood, quality of life, physical ability and collection of personal health, demographic and lifestyle details are the same in ASPREE-XT as those conducted and described for ASPREE.

Since ASPREE-XT is an observational study, the endpoints for ASPREE will be collected and adjudicated in a similar way for ASPREE-XT but will be referred to as ASPREE-XT Outcomes. These will not be divided into primary and secondary endpoints.

In 2018, participants were invited to enroll in ASPREE-XT. At the first ASPREE-XT study visit, or via mail, they were provided with an information sheet and consent form for the study Participants who wish to only be contacted by phone were provided with information and a consent form by mail with health and other study data collected by phone call.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Death from any cause or incident dementia or permanent physical disability.

Time frame: Planned 5-year time frame

These categories of disability are defined, respectively, as a) all-cause mortality, b) the assessment of dementia by DSM-IV criteria or c) the onset of 'a lot of difficulty' or 'inability' to perform independently, any one of 6 Katz ADLs.

Sponsors and collaborators

Lead sponsor

Anne Murray

Other

Collaborators

Bayer
Berman Center for Outcomes and Clinical Research
Monash University
National Cancer Institute (NCI)
National Health and Medical Research Council, Australia
National Institute on Aging (NIA)

Registry information

Important dates

Study start: 2019
Primary completion: 2026
Study completion: 2026
First posted: Nov 4, 2025
Registry last updated: Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting