Aspirin in Reducing Events in the Elderly (ASPREE)

April 2, 2021 updated by: Hennepin Healthcare Research Institute
ASPREE-XT is a post-treatment, longitudinal observational follow-up study of ASPREE participants [ASPREE Investigator Group, 2013; www.aspree.org; McNeil et al 2017]. 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

Intervention / Treatment

Detailed Description

ASPREE BACKGROUND:

ASPREE (ASPirin in Reducing Events in the Elderly) is a joint US/Australian research project aiming to determine whether low-dose aspirin increases healthy life-span, defined as survival free of dementia and disability. ASPREE began in 2010 and completed recruitment in 2014. It is a randomized, double-blind, placebo-controlled, primary prevention trial of daily 100 mg of aspirin in a population of healthy older people in the United States (US) and Australia with a period of treatment averaging 4.5 years. ASPREE's primary outcome is length of survival free of dementia and disability and has secondary outcomes encompassing the major health issues related to aging. The trial involving 19,114 persons aged 70 and above (65 years and above for US minorities) is distinctive for its large size, methodological rigor and high participant retention rate in both countries.

ASPREE UNIQUE ASPECTS:

  1. It is the first large scale trial to incorporate dementia-free and disability-free survival as a primary outcome. This is now recognized as an appropriate goal of treatment in a primary prevention population of this age group. Within a clinical trial context disability-free survival incorporates an estimate of the overall benefits and risks of aspirin in a single outcome measure.
  2. It is one of the first primary prevention trials of aspirin to include cancer incidence, metastases or mortality as a pre-specified endpoint. Recent meta-analyses [Rothwell et al 2010, 2011, 2012] suggests that aspirin has a significant chemopreventive effect becoming evident after a period of 4+ years of aspirin treatment, but questions remain about the magnitude of benefit, and whether it applies to treatment of all cancers and to older people.
  3. It will provide information about the impact of aspirin on a range of other conditions (e.g, dementia, CVD, stroke, depression, bleeding) where aspirin has been claimed to have benefit (or risks).

The intervention phase of the trial ended in June 2017 after the NIA determined that it was highly unlikely that aspirin would show a benefit on the overall primary outcome within the planned 5-year time frame. The study is now entering a data cleaning and analysis phase and it is anticipated that the primary results were published in September 2018.

Study Type

Observational

Enrollment (Actual)

19114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
    • California
      • Palo Alto, California, United States, 94301
        • Palo Alto Medical Foundation Research Institute
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard University
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida Department of Aging and Geriatrics
    • Georgia
      • Atlanta, Georgia, United States, 30310
        • Morehouse School of Medicine
      • Atlanta, Georgia, United States, 30322
        • Emory/ Atlanta VAMC
      • Augusta, Georgia, United States, 30912
        • Georgia Health Sciences University
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Alzheimer's Disease Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Kansas
      • Kansas City, Kansas, United States, 66106
        • Kansas University Medical Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center
      • Baton Rouge, Louisiana, United States, 70809
        • Mary Bird Perkins Our Lady of the Lake Cancer Center
      • New Orleans, Louisiana, United States, 70112
        • Tulane Medical Center
      • New Orleans, Louisiana, United States, 70112
        • LSU Health Sciences- New Orleans
      • Shreveport, Louisiana, United States, 71130
        • LSU Health Sciences- Shreveport
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Detroit, Michigan, United States, 48201
        • Wayne State University
      • Novi, Michigan, United States, 48377
        • Detroit Clinical Research Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55425
        • HealthPartners Research Institute
      • Saint Paul, Minnesota, United States, 55106
        • Phalen Village Clinic
    • New Jersey
      • Elizabeth, New Jersey, United States, 07202
        • Central Jersey Medical Center
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
    • 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 ECU
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh Health Sciences Research Center
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Memorial Hospital of Rhode Island
    • 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 TX 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Men and women recruited from the US and Australia.

  • African American and Hispanic persons age 65 or older in the US
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Placebo
Drug: Placebo
100 mg enteric-coated placebo
Aspirin
100 mg enteric-coated aspirin
Drug: 100 mg enteric-coated aspirin
100 mg enteric-coated aspirin, taken daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary endpoint is death from any cause or incident, dementia or persistent physical disability.
Time Frame: every 6 months
Dementia will be diagnosed based on DSM-IV criteria. Significant physical disability will be defined as a confirmed, and persisting for at least 6 months, self-report of 'a lot of difficulty', or 'inability to perform independently' any one of the 6 Katz basic Activities of Daily Living (ADLs).75
every 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: every 6 months
every 6 months
Fatal and non fatal cardiovascular events including a) coronary heart disease death, b) non-fatal MI, c) fatal and non-fatal stroke and d) any hospitalization for heart failure
Time Frame: every 6 months
every 6 months
Fatal and non-fatal cancer, excluding non-melanoma skin cancer
Time Frame: every 6 months
every 6 months
Dementia
Time Frame: every 6 months
every 6 months
Mild Cognitive Impairment (MCI; assessed using the Modified Mini-Mental State Examination or 3MS 70 and other cognitive function measures - see below)
Time Frame: every 6 months
every 6 months
Physical disability
Time Frame: every 6 months
every 6 months
Major hemorrhagic events
Time Frame: every 6 months
every 6 months
Depression
Time Frame: Annually
Annually

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hennepin Healthcare Research Institute

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

December 1, 2017

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

December 21, 2009

First Submitted That Met QC Criteria

December 23, 2009

First Posted (Estimate)

December 24, 2009

Study Record Updates

Last Update Posted (Actual)

April 5, 2021

Last Update Submitted That Met QC Criteria

April 2, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSR#09-3029
  • 3U01AG029824-07S2 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Working with ASPREE - for Data Access requests Monitored secure portal - development underway

IPD Sharing Time Frame

2019

IPD Sharing Access Criteria

Will be defined in the Working with ASPREE document

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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