Aspirin in Reducing Events in the Elderly-Extension (ASPREE-XT)
NCT ID: NCT07224347
Last Updated: 2025-11-04
Study Results
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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ACTIVE_NOT_RECRUITING
19114 participants
OBSERVATIONAL
2019-07-15
2026-04-30
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
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
* 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 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
65 Years
ALL
Yes
Sponsors
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National Health and Medical Research Council, Australia
OTHER
Bayer
INDUSTRY
Monash University
OTHER
Berman Center for Outcomes and Clinical Research
OTHER
National Institute on Aging (NIA)
NIH
National Cancer Institute (NCI)
NIH
Anne Murray
OTHER
Responsible Party
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Anne Murray
Principal Investigator, Staff Endocrinologist
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
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
University of Michigan
Ann Arbor, Michigan, United States
Wayne State University
Detroit, Michigan, United States
HealthPartners Research Institute
Minneapolis, Minnesota, United States
Phalen Village Clinic
Saint Paul, Minnesota, United States
Wake Forest University Baptist Medical Center
Greensboro, North Carolina, United States
The Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States
Einstein Medical Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Health Sciences Research Center
Pittsburgh, Pennsylvania, United States
Kent County Memorial Hospital
Pawtucket, Rhode Island, United States
University of Tennessee Health Science Center
Memphis, Tennessee, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Regional Academic Health Center
Harlingen, Texas, United States
UT Health Science Center at San Antonio
San Antonio, Texas, 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
Countries
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Other Identifiers
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201904807
Identifier Type: -
Identifier Source: org_study_id
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