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

October 31, 2025 updated by: Anne Murray
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Clinical Trials Unit, The Canberra Hospital
    • New South Wales
      • Wollongong, New South Wales, Australia, 2522
        • Illawarra Health and Medical Research Institute, University of Wollongong
    • South Australia
      • Adelaide, South Australia, Australia, 5005
        • Discipline of General Practice, School of Population Health, University of Adelaide
      • Mount Gambier, South Australia, Australia, 5290
        • Greater Green Triangle University
    • Tasmania
      • Burnie, Tasmania, Australia, 7320
        • University of Tasmania Rural Clinical School
      • Hobart, Tasmania, Australia, 7000
        • The Menzies Institute for Medical Research, University of Tasmania
      • Launceston, Tasmania, Australia, 7250
        • University of Tasmania Newnham Campus
    • Victoria
      • Bendigo, Victoria, Australia, 3550
        • Bendigo Regional Clinical School
      • Geelong, Victoria, Australia, 3220
        • Geelong Hospital
      • Mildura, Victoria, Australia, 3500
        • Monash Mildura Regional Clinical School
      • Mount Helen, Victoria, Australia, 3350
        • University of Ballarat
      • Traralgon, Victoria, Australia, 3844
        • Monash Gippsland Regional Clinical School
      • Warrnambool, Victoria, Australia, 3280
        • The South West Alliance of Rural Health (SWARH)
      • Wodonga, Victoria, Australia, 3690
        • Gateway Community Health
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • The University of Alabama at Birmingham
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20060
        • Howard University
    • Georgia
      • Atlanta, Georgia, United States, 30310
        • Morehouse School Of Medicine
      • Atlanta, Georgia, United States, 30322
        • Emory/ Atlanta VAMC
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Alzheimer's Disease Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center
      • Shreveport, Louisiana, United States, 71130
        • LSU Health Sciences- Shreveport
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • Minnesota
      • Minneapolis, Minnesota, United States, 55425
        • HealthPartners Research Institute
      • Saint Paul, Minnesota, United States, 55106
        • Phalen Village Clinic
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Wake Forest University Baptist Medical Center
      • Greenville, North Carolina, United States, 27834
        • The Brody School of Medicine at East Carolina University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Einstein Medical Center
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh Health Sciences Research Center
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Kent County Memorial Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • University of Tennessee Health Science Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center at Dallas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch
      • Harlingen, Texas, United States, 78550
        • Regional Academic Health Center
      • San Antonio, Texas, United States, 78229
        • UT Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Men and women recruited from the United States and Australia.

  • African American and Hispanic persons age 65 or older in the U.S.
  • 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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Placebo
Aspirin
100 mg enteric-coated aspirin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Planned 5-year time frame

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anne Murray

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Health and Medical Research Council, Australia
National Cancer Institute (NCI)
Bayer
National Institute on Aging (NIA)
Monash University
Berman Center for Outcomes and Clinical Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anne Murray, MD, MSc, Berman Center for Outcomes and Clinical Research
  • Principal Investigator: John McNeil, MBBS, PHD, Monash University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201904807
  • U19AG062682 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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