Aspirin in Reducing Events in the Elderly-Extension (ASPREE-XT)
2 other identifiers
observational
19,114
2 countries
36
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2019
Longer than P75 for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2019
CompletedFirst Submitted
Initial submission to the registry
October 31, 2025
CompletedFirst Posted
Study publicly available on registry
November 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedNovember 4, 2025
January 1, 2025
6.8 years
October 31, 2025
October 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Death from any cause or incident dementia or permanent physical disability.
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
Study Arms (2)
Aspirin
100 mg enteric-coated aspirin
Placebo
Placebo
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anne Murraylead
- National Health and Medical Research Council, Australiacollaborator
- Bayercollaborator
- Monash Universitycollaborator
- Berman Center for Outcomes and Clinical Researchcollaborator
- National Institute on Aging (NIA)collaborator
- National Cancer Institute (NCI)collaborator
Study Sites (36)
The University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Howard University
Washington D.C., District of Columbia, 20060, United States
Morehouse School of Medicine
Atlanta, Georgia, 30310, United States
Emory/ Atlanta VAMC
Atlanta, Georgia, 30322, United States
Rush Alzheimer's Disease Center
Chicago, Illinois, 60612, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
LSU Health Sciences- Shreveport
Shreveport, Louisiana, 71130, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Wayne State University
Detroit, Michigan, 48201, United States
HealthPartners Research Institute
Minneapolis, Minnesota, 55425, United States
Phalen Village Clinic
Saint Paul, Minnesota, 55106, United States
Wake Forest University Baptist Medical Center
Greensboro, North Carolina, 27408, United States
The Brody School of Medicine at East Carolina University
Greenville, North Carolina, 27834, United States
Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
University of Pittsburgh Health Sciences Research Center
Pittsburgh, Pennsylvania, 15260, United States
Kent County Memorial Hospital
Pawtucket, Rhode Island, 02860, United States
University of Tennessee Health Science Center
Memphis, Tennessee, 38105, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
Regional Academic Health Center
Harlingen, Texas, 78550, United States
UT Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Clinical Trials Unit, The Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Illawarra Health and Medical Research Institute, University of Wollongong
Wollongong, New South Wales, 2522, Australia
Discipline of General Practice, School of Population Health, University of Adelaide
Adelaide, South Australia, 5005, Australia
Greater Green Triangle University
Mount Gambier, South Australia, 5290, Australia
University of Tasmania Rural Clinical School
Burnie, Tasmania, 7320, Australia
The Menzies Institute for Medical Research, University of Tasmania
Hobart, Tasmania, 7000, Australia
University of Tasmania Newnham Campus
Launceston, Tasmania, 7250, Australia
Bendigo Regional Clinical School
Bendigo, Victoria, 3550, Australia
Geelong Hospital
Geelong, Victoria, 3220, Australia
Monash Mildura Regional Clinical School
Mildura, Victoria, 3500, Australia
University of Ballarat
Mount Helen, Victoria, 3350, Australia
Monash Gippsland Regional Clinical School
Traralgon, Victoria, 3844, Australia
The South West Alliance of Rural Health (SWARH)
Warrnambool, Victoria, 3280, Australia
Gateway Community Health
Wodonga, Victoria, 3690, Australia
Biospecimen
Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Murray, MD, MSc
Berman Center for Outcomes and Clinical Research
- PRINCIPAL INVESTIGATOR
John McNeil, MBBS, PHD
Monash University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator, Staff Endocrinologist
Study Record Dates
First Submitted
October 31, 2025
First Posted
November 4, 2025
Study Start
July 15, 2019
Primary Completion
April 30, 2026
Study Completion
April 30, 2026
Last Updated
November 4, 2025
Record last verified: 2025-01