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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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
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Scientific title
Aspirin in Reducing Events in the Elderly
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Secondary ID [1]
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3U01AG029824-07S2
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Secondary ID [2]
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HSR#09-3029
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Universal Trial Number (UTN)
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Trial acronym
ASPREE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Functional Disability
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Dementia
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Heart Disease
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Stroke
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Cancer
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Bleeding
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Depression
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Condition category
Condition code
Neurological
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Dementias
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Neurological
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Alzheimer's disease
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Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The primary endpoint is death from any cause or incident, dementia or persistent physical disability.
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Assessment method [1]
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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
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Timepoint [1]
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every 6 months
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Secondary outcome [1]
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All-cause mortality
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Assessment method [1]
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0
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Timepoint [1]
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every 6 months
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Secondary outcome [2]
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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
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Assessment method [2]
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Timepoint [2]
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every 6 months
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Secondary outcome [3]
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Fatal and non-fatal cancer, excluding non-melanoma skin cancer
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Assessment method [3]
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Timepoint [3]
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every 6 months
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Secondary outcome [4]
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Dementia
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Assessment method [4]
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Timepoint [4]
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every 6 months
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Secondary outcome [5]
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Mild Cognitive Impairment (MCI; assessed using the Modified Mini-Mental State Examination or 3MS 70 and other cognitive function measures - see below)
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Assessment method [5]
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Timepoint [5]
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every 6 months
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Secondary outcome [6]
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Physical disability
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Assessment method [6]
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Timepoint [6]
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every 6 months
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Secondary outcome [7]
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Major hemorrhagic events
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Assessment method [7]
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Timepoint [7]
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every 6 months
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Secondary outcome [8]
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Depression
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Assessment method [8]
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Timepoint [8]
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Annually
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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
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
19114
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,TAS,VIC
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Recruitment hospital [1]
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Clinical Trials Unit, The Canberra Hospital - Garran
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Recruitment hospital [2]
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Illawarra Health and Medical Research Institute, University of Wollongong - Wollongong
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Discipline of General Practice, School of Population Health, University of Adelaide - Adelaide
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Greater Green Triangle University - Mount Gambier
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Recruitment hospital [5]
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University of Tasmania Rural Clinical School - Burnie
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The Menzies Institute for Medical Research, University of Tasmania - Hobart
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Recruitment hospital [7]
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University of Tasmania Newnham Campus - Launceston
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Bendigo Regional Clinical School - Bendigo
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Recruitment hospital [9]
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Geelong Hospital - Geelong
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Recruitment hospital [10]
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Monash Mildura Regional Clinical School - Mildura
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Recruitment hospital [11]
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University of Ballarat - Mount Helen
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Recruitment hospital [12]
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Monash Gippsland Regional Clinical School - Traralgon
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Recruitment hospital [13]
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The South West Alliance of Rural Health (SWARH) - Warrnambool
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Recruitment hospital [14]
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Gateway Community Health - Wodonga
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2522 - Wollongong
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Recruitment postcode(s) [3]
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5005 - Adelaide
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Recruitment postcode(s) [4]
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5290 - Mount Gambier
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Recruitment postcode(s) [5]
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7320 - Burnie
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Recruitment postcode(s) [6]
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7000 - Hobart
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Recruitment postcode(s) [7]
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7250 - Launceston
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Recruitment postcode(s) [8]
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3550 - Bendigo
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Recruitment postcode(s) [9]
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3220 - Geelong
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Recruitment postcode(s) [10]
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3500 - Mildura
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Recruitment postcode(s) [11]
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3350 - Mount Helen
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Recruitment postcode(s) [12]
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3844 - Traralgon
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Recruitment postcode(s) [13]
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3280 - Warrnambool
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Recruitment postcode(s) [14]
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3690 - Wodonga
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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California
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District of Columbia
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Florida
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Georgia
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Illinois
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Iowa
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Kansas
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Louisiana
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Michigan
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Minnesota
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New Jersey
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New York
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North Carolina
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Pennsylvania
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Rhode Island
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Tennessee
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United States of America
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Texas
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Funding & Sponsors
Primary sponsor type
Other
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Name
Hennepin Healthcare Research Institute
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Address
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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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Bayer
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Monash University
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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Berman Center for Outcomes and Clinical Research
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Address [4]
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Other collaborator category [5]
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Government body
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Name [5]
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National Institute on Aging (NIA)
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Address [5]
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Other collaborator category [6]
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Government body
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Name [6]
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National Cancer Institute (NCI)
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01038583
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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.
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Public notes
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Contacts
Principal investigator
Name
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Anne Murray, MD, MSc
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Address
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Berman Center for Outcomes and Clinical Research
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01038583
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