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

NCT ID: NCT07224347

Last Updated: 2025-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

19114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-15

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Functional Disability Dementia Heart Disease Stroke Cancer Bleeding Depression Frailty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Aspirin

100 mg enteric-coated aspirin

No interventions assigned to this group

Placebo

Placebo

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Health and Medical Research Council, Australia

OTHER

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role collaborator

Monash University

OTHER

Sponsor Role collaborator

Berman Center for Outcomes and Clinical Research

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Anne Murray

OTHER

Sponsor Role lead

Responsible Party

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Anne Murray

Principal Investigator, Staff Endocrinologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anne Murray, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Berman Center for Outcomes and Clinical Research

John McNeil, MBBS, PHD

Role: PRINCIPAL_INVESTIGATOR

Monash University

Locations

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The University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Howard University

Washington D.C., District of Columbia, United States

Site Status

Morehouse School of Medicine

Atlanta, Georgia, United States

Site Status

Emory/ Atlanta VAMC

Atlanta, Georgia, United States

Site Status

Rush Alzheimer's Disease Center

Chicago, Illinois, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

LSU Health Sciences- Shreveport

Shreveport, Louisiana, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

HealthPartners Research Institute

Minneapolis, Minnesota, United States

Site Status

Phalen Village Clinic

Saint Paul, Minnesota, United States

Site Status

Wake Forest University Baptist Medical Center

Greensboro, North Carolina, United States

Site Status

The Brody School of Medicine at East Carolina University

Greenville, North Carolina, United States

Site Status

Einstein Medical Center

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Health Sciences Research Center

Pittsburgh, Pennsylvania, United States

Site Status

Kent County Memorial Hospital

Pawtucket, Rhode Island, United States

Site Status

University of Tennessee Health Science Center

Memphis, Tennessee, United States

Site Status

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

University of Texas Medical Branch

Galveston, Texas, United States

Site Status

Regional Academic Health Center

Harlingen, Texas, United States

Site Status

UT Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

Clinical Trials Unit, The Canberra Hospital

Garran, Australian Capital Territory, Australia

Site Status

Illawarra Health and Medical Research Institute, University of Wollongong

Wollongong, New South Wales, Australia

Site Status

Discipline of General Practice, School of Population Health, University of Adelaide

Adelaide, South Australia, Australia

Site Status

Greater Green Triangle University

Mount Gambier, South Australia, Australia

Site Status

University of Tasmania Rural Clinical School

Burnie, Tasmania, Australia

Site Status

The Menzies Institute for Medical Research, University of Tasmania

Hobart, Tasmania, Australia

Site Status

University of Tasmania Newnham Campus

Launceston, Tasmania, Australia

Site Status

Bendigo Regional Clinical School

Bendigo, Victoria, Australia

Site Status

Geelong Hospital

Geelong, Victoria, Australia

Site Status

Monash Mildura Regional Clinical School

Mildura, Victoria, Australia

Site Status

University of Ballarat

Mount Helen, Victoria, Australia

Site Status

Monash Gippsland Regional Clinical School

Traralgon, Victoria, Australia

Site Status

The South West Alliance of Rural Health (SWARH)

Warrnambool, Victoria, Australia

Site Status

Gateway Community Health

Wodonga, Victoria, Australia

Site Status

Countries

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United States Australia

Other Identifiers

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U19AG062682

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201904807

Identifier Type: -

Identifier Source: org_study_id

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