Condition category
Circulatory System
Date applied
03/05/2005
Date assigned
14/07/2005
Last edited
29/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.med.monash.edu.au/epidemiology/cardiores/aspree.html

Contact information

Type

Scientific

Primary contact

Prof John McNeil

ORCID ID

Contact details

Department of Epidemiology and Preventive Medicine
Monash University
Alfred Hospital
Commercial Rd
Melbourne
3004
Australia
+61 (0)3 9903 0555
john.mcneil@med.monash.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Aspirin in reducing events in the elderly: a randomised controlled trial

Acronym

ASPREE

Study hypothesis

Hypothesis amended as of 14/03/2008:
Null hypothesis: Low-dose aspirin does not prolong life free of mental or physical disability in those aged 70 years and over who has not manifested cardiovascular disease or dementia.

Provided at time of registration:
Null hypothesis: Low-dose aspirin has no overall benefit in those aged 70 years and over who do not have manifest cardiovascular disease or dementia.

Ethics approval

Added 20/02/2009:
1. The Royal Australasian College of General Practitioners Ethics Committee: approved 2002 (ref: NREEC 02/22b)
2. Monash University Human Research Ethics Committee: approved 2006 (ref: 2006/745MC)
3. The Tasmanian Human Research Ethics Committee: approved 2006 (ref: H0008933)
4. The Goulburn Valley Health Ethics & Research Committee, Shepparton: approved 2007 (ref: GVH-21/07)
5. The ACT Health Human Research Ethics Committee, Canberra: approved 2007 (ref: 11/07.997)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Condition

Mental and physical disability in the elderly

Intervention

Please note that, as of 14/03/2008, the anticipated end date of this trial was updated from 30/06/2005 to 31/12/2015.

Acetylsalicylic acid 100 mg: enteric coated unscored white tablet

Placebo of acetylsalicylic acid: enteric coated unscored white tablet with identical appearance

Intervention type

Drug

Phase

Not Applicable

Drug names

Acetylsalicylic acid

Primary outcome measures

Amended 02/03/2009:
1. Death from any cause, or
2. Incident dementia (defined according to the Diagnostic and Statistical Manual for Mental Disorders 4th edition (DSM-IV) criteria), or
3. Persistent physical disability (defined as the onset of a lot of difficulty to inability to perform any one of 6 Katz Activities of Daily Living)

Updated as of 14/03/2008:
1. Death from any cause
2. Death from incident dementia (defined according to the Diagnostic and Statistical Manual for Mental Disorders 4th edition (DSM-IV) criteria)
3. Death from persistent physical disability (defined as progression by at least 2 intervals on a 5-point scale of any one of the 6 Katz Activities of Daily Living)

Provided at time of registration:
1. Coronary artery disease death
2. Cardiac failure death (with coronary cause), and other coronary death
3. Cardiac failure death - due to heart failure (prior grade III-IV dyspnea New York Heart Association [NYHA]), with any defined non-coronary cause
4. Other vascular death
5. Non-coronary cardiac death
6. Cerebrovascular disease death
7. Non-fatal cardiovascular events
8. Non-fatal cerebrovascular events

Secondary outcome measures

Secondary outcome measures updated as of 14/03/2008:
1. All-cause mortality
2. Fatal and non-fatal cardiovascular events including:
2.1. Coronary heart disease death
2.3. Non-fatal myocardial infarction
2.3. Fatal and non-fatal stroke
2.4. Hospitalisation for heart failure
3. Fatal and non-fatal cancer, excluding non-melanomatous skin cancer
4. Dementia
5. Cognitive decline
6. Physical disability
7. Major haemorrhagic events

Secondary outcome measures provided at time of registration:
1. All-cause dementia – Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria
2. Cognitive decline - defined as 2 point decline on 3MSE supplemented by a Color Trail test
3. Clinically significant bleeding including gastrointestinal hemorrhages or hemorrhages at other sites that required transfusion, hospitalization and or surgery

Tertiary outcomes:
1. Haemorrhagic stroke
2. Transient ischaemic attack
3. Hospitalisation for unstable angina
4. Total mortality
5. Cognitive decline
6. Depression score
7. Quality of life
8. Disability
9. A fall in haemoglobin
10. Fatal and non-fatal cancer
11. Total hospitalisations
12. Hospitalisation for reasons other than primary endpoints
13. Institutionalisation
14. Cost-effectiveness of aspirin
15. Public health outcomes
16. Development of a multivariate model which predicts in different age strata (70-79 and 80+ years) the likelihood of death, dementia, disability, and self-assessed quality of life
17. Risk-benefit trade-off associated with the use of aspirin in different categories

Overall trial start date

01/03/2003

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

All subjects will be aged 70 years or more and capable of attending their usual family physician's clinic and providing informed consent.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

As of 20/02/2009: 19,000 (at time of registration: 20,500; as of 14/03/2008: 18,000)

Participant exclusion criteria

1. A history of cardiovascular morbidity defined as myocardial infarction, stroke, peripheral vascular disease, angina, transient ischaemic attack, greater than 50% carotid stenosis or previous carotid endarterectomy or stenting, coronary artery angioplasty or stenting, or coronary artery bypass grafting
2. A serious intercurrent illness likely to cause death within the next 5 years
3. A current or recurrent condition with a high risk of major bleeding e.g. cerebral aneurysm or cerebral arteriovenous (AV) malformation, any bleeding diathesis, gastrointestinal malignancy, peptic ulcer, liver disease, uraemia, aortic aneurysm or any other condition known to be associated with a high risk of serious bleeding
4. Absolute contraindication or allergy to aspirin
5. Current participation in a clinical trial
6. Current continuous use of aspirin or other anti-platelet drug or anticoagulant
7. A history of diabetes or dementia
8. In addition those who lie outside of tolerance levels of 8-104% during placebo run-in phase will not be randomised

The following criteria were added as of 14/03/2008:
9. An inability to perform independently one of the 6 Katz Activities of Daily Living (walking, bathing, dressing, transferring from chair or bed, toileting, eating)
10. Pill taking compliance below 80% on tablet count during a placebo run-in phase

The following criterion was amended to the below text as of 20/02/2009:
7. A history of dementia

Recruitment start date

01/03/2003

Recruitment end date

31/12/2015

Locations

Countries of recruitment

Australia

Trial participating centre

Department of Epidemiology and Preventive Medicine
Melbourne
3004
Australia

Sponsor information

Organisation

Monash University (Australia)

Sponsor details

Research and Graduate Programs Office
Faculty of Medicine
Nursing and Health Sciences
PO Box 64
Monash University
Victoria
3800
Australia
+61 (0)3 9905 1206
robyn.woods@med.monash.edu.au

Sponsor type

University/education

Website

http://www.monash.edu.au/

Funders

Funder type

Research council

Funder name

Australian National Health and Medical Research Council (NHMRC) (Australia) (ref: 334047)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Heart Foundation of Australia (Australia)

Alternative name(s)

Heart Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Australia

Funder name

Bayer AG (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2003 rationale in: http://www.ncbi.nlm.nih.gov/pubmed/14565783
2013 design in: http://www.ncbi.nlm.nih.gov/pubmed/24113028

Publication citations

  1. Rationale

    Nelson M, Reid C, Beilin L, Donnan G, Johnston C, Krum H, Storey E, Tonkin A, McNeil J, , Rationale for a trial of low-dose aspirin for the primary prevention of major adverse cardiovascular events and vascular dementia in the elderly: Aspirin in Reducing Events in the Elderly (ASPREE)., Drugs Aging, 2003, 20, 12, 897-903.

  2. Design

    Study design of ASPirin in Reducing Events in the Elderly (ASPREE): a randomized, controlled trial., Contemp Clin Trials, 2013, 36, 2, 555-564, doi: 10.1016/j.cct.2013.09.014.

Additional files

Editorial Notes