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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Stroke; Cancer; Bleeding; Dementia; Frailty; Heart Disease; Functional Disability

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: Observational
• Enrollment (Actual): 19114

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Placebo
Aspirin; 100 mg enteric-coated aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Anne Murray
• Collaborators: 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: Principal Investigator: Anne Murray, MD, MSc, Berman Center for Outcomes and Clinical Research; Principal Investigator: John McNeil, MBBS, PHD, Monash University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: October 31, 2025
• First Submitted That Met QC Criteria: October 31, 2025
• First Posted (Estimated): November 4, 2025

Study Record Updates

• Last Update Posted (Estimated): November 4, 2025
• Last Update Submitted That Met QC Criteria: October 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Aspirin; Cancer; Healthy; Dementia; Australia; Prevention; Bleeding; Frailty; Functional Disability; Older Adult; Community-Dwelling; Over 70 years old; ASPREE; Aspirin in Reducing Events in the Elderly; Heart Disease/ Stroke
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Pathologic Processes; Behavioral Symptoms; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Frailty; Stroke; Neoplasms; Depression; Heart Diseases; Dementia; Hemorrhage
• Other Study ID 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