|
Welcome
|
|
23 May 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| ASPirin in Reducing Events in the Elderly |
| ISRCTN | ISRCTN83772183 |
| ClinicalTrials.gov identifier | |
| Public title | ASPirin in Reducing Events in the Elderly |
| Scientific title | Aspirin in reducing events in the elderly: a randomised controlled trial |
| Acronym | ASPREE |
| Serial number at source | N/A |
| 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. |
| Lay summary | |
| 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 |
| Countries of recruitment | Australia |
| Disease/condition/study domain | Mental and physical disability in the elderly |
| Participants - 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. |
| Participants - 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 |
| Anticipated start date | 01/03/2003 |
| Anticipated end date | 31/12/2015 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | As of 20/02/2009: 19,000 (at time of registration: 20,500; as of 14/03/2008: 18,000) |
| Interventions |
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 |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding |
1. Australian National Health and Medical Research Council (NHMRC) (Australia) (ref: 334047)
2. National Heart Foundation of Australia (Australia) 3. Bayer AG (Australia) |
| Trial website | http://www.med.monash.edu.au/epidemiology/cardiores/aspree.html |
| Publications | Study protocol on http://www.ncbi.nlm.nih.gov/pubmed/14565783 |
| Contact name | Prof John McNeil |
| Address |
Department of Epidemiology and Preventive Medicine
Monash University Alfred Hospital Commercial Rd |
| City/town | Melbourne |
| Zip/Postcode | 3004 |
| Country | Australia |
| Tel | +61 (0)3 9903 0555 |
| Fax | +61 (0)3 9903 0556 |
| john.mcneil@med.monash.edu.au | |
| Sponsor | Monash University (Australia) |
| Address |
Research and Graduate Programs Office
Faculty of Medicine, Nursing and Health Sciences PO Box 64 Monash University |
| City/town | Victoria |
| Zip/Postcode | 3800 |
| Country | Australia |
| Tel | +61 (0)3 9905 1206 |
| Fax | +61 (0)3 9905 4302 |
| robyn.woods@med.monash.edu.au | |
| Sponsor website: | http://www.monash.edu.au/ |
| Date applied | 03/05/2005 |
| Last edited | 02/03/2009 |
| Date ISRCTN assigned | 14/07/2005 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|