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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01038583
Ethics application status
Date submitted
21/12/2009
Date registered
24/12/2009

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.
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
Sex
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
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
Accrual to date
Final
19114
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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Working with ASPREE - for Data Access requests Monitored secure portal - development underway

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
2019
Available to whom?
Will be defined in the Working with ASPREE document
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01038583