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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01038583




Registration number
NCT01038583
Ethics application status
Date submitted
21/12/2009
Date registered
24/12/2009
Date last updated
5/04/2021

Titles & IDs
Public title
Aspirin in Reducing Events in the Elderly
Scientific title
Aspirin in Reducing Events in the Elderly
Secondary ID [1] 0 0
3U01AG029824-07S2
Secondary ID [2] 0 0
HSR#09-3029
Universal Trial Number (UTN)
Trial acronym
ASPREE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional Disability 0 0
Dementia 0 0
Heart Disease 0 0
Stroke 0 0
Cancer 0 0
Bleeding 0 0
Depression 0 0
Condition category
Condition code
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Alzheimer's disease
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - 100 mg enteric-coated aspirin
Treatment: Drugs - Placebo

Aspirin - 100 mg enteric-coated aspirin

Placebo - Placebo


Treatment: Drugs: 100 mg enteric-coated aspirin
100 mg enteric-coated aspirin, taken daily

Treatment: Drugs: Placebo
100 mg enteric-coated placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary endpoint is death from any cause or incident, dementia or persistent physical disability. - 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
Timepoint [1] 0 0
every 6 months
Secondary outcome [1] 0 0
All-cause mortality
Timepoint [1] 0 0
every 6 months
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
every 6 months
Secondary outcome [3] 0 0
Fatal and non-fatal cancer, excluding non-melanoma skin cancer
Timepoint [3] 0 0
every 6 months
Secondary outcome [4] 0 0
Dementia
Timepoint [4] 0 0
every 6 months
Secondary outcome [5] 0 0
Mild Cognitive Impairment (MCI; assessed using the Modified Mini-Mental State Examination or 3MS 70 and other cognitive function measures - see below)
Timepoint [5] 0 0
every 6 months
Secondary outcome [6] 0 0
Physical disability
Timepoint [6] 0 0
every 6 months
Secondary outcome [7] 0 0
Major hemorrhagic events
Timepoint [7] 0 0
every 6 months
Secondary outcome [8] 0 0
Depression
Timepoint [8] 0 0
Annually

Eligibility
Key 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
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,TAS,VIC
Recruitment hospital [1] 0 0
Clinical Trials Unit, The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Illawarra Health and Medical Research Institute, University of Wollongong - Wollongong
Recruitment hospital [3] 0 0
Discipline of General Practice, School of Population Health, University of Adelaide - Adelaide
Recruitment hospital [4] 0 0
Greater Green Triangle University - Mount Gambier
Recruitment hospital [5] 0 0
University of Tasmania Rural Clinical School - Burnie
Recruitment hospital [6] 0 0
The Menzies Institute for Medical Research, University of Tasmania - Hobart
Recruitment hospital [7] 0 0
University of Tasmania Newnham Campus - Launceston
Recruitment hospital [8] 0 0
Bendigo Regional Clinical School - Bendigo
Recruitment hospital [9] 0 0
Geelong Hospital - Geelong
Recruitment hospital [10] 0 0
Monash Mildura Regional Clinical School - Mildura
Recruitment hospital [11] 0 0
University of Ballarat - Mount Helen
Recruitment hospital [12] 0 0
Monash Gippsland Regional Clinical School - Traralgon
Recruitment hospital [13] 0 0
The South West Alliance of Rural Health (SWARH) - Warrnambool
Recruitment hospital [14] 0 0
Gateway Community Health - Wodonga
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2522 - Wollongong
Recruitment postcode(s) [3] 0 0
5005 - Adelaide
Recruitment postcode(s) [4] 0 0
5290 - Mount Gambier
Recruitment postcode(s) [5] 0 0
7320 - Burnie
Recruitment postcode(s) [6] 0 0
7000 - Hobart
Recruitment postcode(s) [7] 0 0
7250 - Launceston
Recruitment postcode(s) [8] 0 0
3550 - Bendigo
Recruitment postcode(s) [9] 0 0
3220 - Geelong
Recruitment postcode(s) [10] 0 0
3500 - Mildura
Recruitment postcode(s) [11] 0 0
3350 - Mount Helen
Recruitment postcode(s) [12] 0 0
3844 - Traralgon
Recruitment postcode(s) [13] 0 0
3280 - Warrnambool
Recruitment postcode(s) [14] 0 0
3690 - Wodonga
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Rhode Island
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Other
Name
Hennepin Healthcare Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Bayer
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Monash University
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Berman Center for Outcomes and Clinical Research
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Government body
Name [5] 0 0
National Institute on Aging (NIA)
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Government body
Name [6] 0 0
National Cancer Institute (NCI)
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01038583
Trial related presentations / publications
Barker AL, McNeil JJ, Seeman E, Ward SA, Sanders KM, Khosla S, Cumming RG, Pasco JA, Bohensky MA, Ebeling PR, Woods RL, Lockery JE, Wolfe R, Talevski J; ASPREE Investigator Group. A randomised controlled trial of low-dose aspirin for the prevention of fractures in healthy older people: protocol for the ASPREE-Fracture substudy. Inj Prev. 2016 Aug;22(4):297-301. doi: 10.1136/injuryprev-2015-041655. Epub 2015 May 21.
ASPREE Investigator Group. Study design of ASPirin in Reducing Events in the Elderly (ASPREE): a randomized, controlled trial. Contemp Clin Trials. 2013 Nov;36(2):555-64. doi: 10.1016/j.cct.2013.09.014. Epub 2013 Oct 7.
Public notes

Contacts
Principal investigator
Name 0 0
Anne Murray, MD, MSc
Address 0 0
Berman Center for Outcomes and Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications