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

NCT07224347 · tracked via the Priya Life Science Australia tracker

Sponsor

Anne Murray

Phase

Observational

Started

2019-07-15

Last updated

2025-11-04

Condition(s) studied

Functional DisabilityDementiaHeart DiseaseStrokeCancerBleedingDepressionFrailty

Study 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.

Eligibility

Sex

ALL

Min age

65 Years

Max age

—

Healthy volunteers

Accepted

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

Primary outcome measure(s)

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

Trial sites (36)

Facility	City	Region
The University of Alabama at Birmingham	Birmingham	Alabama
Howard University	Washington D.C.	District of Columbia
Morehouse School of Medicine	Atlanta	Georgia
Emory/ Atlanta VAMC	Atlanta	Georgia
Rush Alzheimer's Disease Center	Chicago	Illinois
University of Iowa	Iowa City	Iowa
Pennington Biomedical Research Center	Baton Rouge	Louisiana
LSU Health Sciences- Shreveport	Shreveport	Louisiana
University of Michigan	Ann Arbor	Michigan
Wayne State University	Detroit	Michigan
HealthPartners Research Institute	Minneapolis	Minnesota
Phalen Village Clinic	Saint Paul	Minnesota
Wake Forest University Baptist Medical Center	Greensboro	North Carolina
The Brody School of Medicine at East Carolina University	Greenville	North Carolina
Einstein Medical Center	Philadelphia	Pennsylvania
University of Pittsburgh Health Sciences Research Center	Pittsburgh	Pennsylvania
Kent County Memorial Hospital	Pawtucket	Rhode Island
University of Tennessee Health Science Center	Memphis	Tennessee
University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
University of Texas Medical Branch	Galveston	Texas
Regional Academic Health Center	Harlingen	Texas
UT Health Science Center at San Antonio	San Antonio	Texas
Clinical Trials Unit, The Canberra Hospital	Garran	Australian Capital Territory
Illawarra Health and Medical Research Institute, University of Wollongong	Wollongong	New South Wales
Discipline of General Practice, School of Population Health, University of Adelaide	Adelaide	South Australia
Greater Green Triangle University	Mount Gambier	South Australia
University of Tasmania Rural Clinical School	Burnie	Tasmania
The Menzies Institute for Medical Research, University of Tasmania	Hobart	Tasmania
University of Tasmania Newnham Campus	Launceston	Tasmania
Bendigo Regional Clinical School	Bendigo	Victoria
Geelong Hospital	Geelong	Victoria
Monash Mildura Regional Clinical School	Mildura	Victoria
University of Ballarat	Mount Helen	Victoria
Monash Gippsland Regional Clinical School	Traralgon	Victoria
The South West Alliance of Rural Health (SWARH)	Warrnambool	Victoria
Gateway Community Health	Wodonga	Victoria

More Anne Murray trials in Australia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07224347 on ClinicalTrials.gov ↗ ← All trials in Australia