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

Running, not enrolling

Conditions studied: Functional Disability, Dementia, Heart Disease, Stroke, Cancer, Bleeding, Depression, Frailty

In brief

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.

Key facts

Study ID

NCT07224347

Run by

Anne Murray

People needed

19114

Starts

2019-07-15

Expected to finish

2026-04-30

Last updated by the study team

2025-11-04

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Einstein Medical Center — Philadelphia, Pennsylvania, United States
• UT Health Science Center at San Antonio — San Antonio, Texas, United States
• University of Pittsburgh Health Sciences Research Center — Pittsburgh, Pennsylvania, United States
• Kent County Memorial Hospital — Pawtucket, Rhode Island, United States
• Clinical Trials Unit, The Canberra Hospital — Garran, Australian Capital Territory, Australia
• Illawarra Health and Medical Research Institute, University of Wollongong — Wollongong, New South Wales, Australia
• Discipline of General Practice, School of Population Health, University of Adelaide — Adelaide, South Australia, Australia
• Greater Green Triangle University — Mount Gambier, South Australia, Australia
• University of Tasmania Rural Clinical School — Burnie, Tasmania, Australia
• The Menzies Institute for Medical Research, University of Tasmania — Hobart, Tasmania, Australia
• University of Tasmania Newnham Campus — Launceston, Tasmania, Australia
• Bendigo Regional Clinical School — Bendigo, Victoria, Australia
• Geelong Hospital — Geelong, Victoria, Australia
• Monash Mildura Regional Clinical School — Mildura, Victoria, Australia
• University of Ballarat — Mount Helen, Victoria, Australia
• Monash Gippsland Regional Clinical School — Traralgon, Victoria, Australia
• The South West Alliance of Rural Health (SWARH) — Warrnambool, Victoria, Australia
• Gateway Community Health — Wodonga, Victoria, Australia
• Howard University — Washington D.C., District of Columbia, United States
• Morehouse School of Medicine — Atlanta, Georgia, United States
• Emory/ Atlanta VAMC — Atlanta, Georgia, United States
• Rush Alzheimer's Disease Center — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
• LSU Health Sciences- Shreveport — Shreveport, Louisiana, United States

Full record on ClinicalTrials.gov

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