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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
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.
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
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/study/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.
Zhou Z, Nelson M, Ernst ME, Reid C, McNeil J, Tonkin A; ASPREE Investigator Group. Does Aspirin Prevent Incident Heart Failure in Healthy Older Adults? Examining the Evidence From the ASPREE Trial. Circ Heart Fail. 2022 Jun;15(6):e009511. doi: 10.1161/CIRCHEARTFAILURE.122.009511. Epub 2022 Apr 5. No abstract available.
Yan MK, Orchard SG, Adler NR, Wolfe R, McLean C, Rodriguez LM, Woods RL, Gibbs P, Chan AT, Haydon A, Mar VJ. Association between hypertension and cutaneous melanoma, and the effect of aspirin: extended follow-up of a large randomised controlled trial. Cancer Epidemiol. 2022 Aug;79:102173. doi: 10.1016/j.canep.2022.102173. Epub 2022 May 11.
Neumann JT, Thao LTP, Murray AM, Callander E, Carr PR, Nelson MR, Wolfe R, Woods RL, Reid CM, Shah RC, Newman AB, Williamson JD, Tonkin AM, McNeil JJ; ASPREE investigators. Prediction of disability-free survival in healthy older people. Geroscience. 2022 Jun;44(3):1641-1655. doi: 10.1007/s11357-022-00547-x. Epub 2022 Apr 14.
Islam RM, Bell RJ, Handelsman DJ, McNeil JJ, Nelson MR, Reid CM, Tonkin AM, Wolfe RS, Woods RL, Davis SR. Associations between blood sex steroid concentrations and risk of major adverse cardiovascular events in healthy older women in Australia: a prospective cohort substudy of the ASPREE trial. Lancet Healthy Longev. 2022 Feb;3(2):e109-e118. doi: 10.1016/S2666-7568(22)00001-0. Epub 2022 Feb 7. Erratum In: Lancet Healthy Longev. 2023 Aug;4(8):e373. doi: 10.1016/S2666-7568(23)00128-9.
Neumann JT, Riaz M, Bakshi A, Polekhina G, Thao LTP, Nelson MR, Woods RL, Abraham G, Inouye M, Reid CM, Tonkin AM, McNeil J, Lacaze P. Prognostic Value of a Polygenic Risk Score for Coronary Heart Disease in Individuals Aged 70 Years and Older. Circ Genom Precis Med. 2022 Feb;15(1):e003429. doi: 10.1161/CIRCGEN.121.003429. Epub 2021 Dec 24.
Yan MK, Wolfe R, Orchard SG, Ernst ME, Mar VJ. Effect of methotrexate on melanoma risk in older adults: Secondary analysis of a randomised controlled trial. Australas J Dermatol. 2022 Feb;63(1):114-115. doi: 10.1111/ajd.13727. Epub 2021 Sep 28. No abstract available.
Ernst ME, Fravel MA, Webb KL, Wetmore JB, Wolfe R, Chowdhury E, Reid CM, Woods RL, Beilin L, Margolis KL, Murray AM, Polkinghorne KR. Long-Term Blood Pressure Variability and Kidney Function in Participants of the ASPREE Trial. Am J Hypertens. 2022 Feb 1;35(2):173-181. doi: 10.1093/ajh/hpab143.
Lacaze P, Riaz M, Sebra R, Hooper AJ, Pang J, Tiller J, Polekhina G, Tonkin A, Reid C, Zoungas S, Murray AM, Nicholls S, Watts G, Schadt E, McNeil JJ. Protective lipid-lowering variants in healthy older individuals without coronary heart disease. Open Heart. 2021 Jul;8(2):e001710. doi: 10.1136/openhrt-2021-001710.
Ernst ME, Ryan J, Chowdhury EK, Margolis KL, Beilin LJ, Reid CM, Nelson MR, Woods RL, Shah RC, Orchard SG, Wolfe R, Storey E, Tonkin AM, Brodtmann A, McNeil JJ, Murray AM. Long-Term Blood Pressure Variability and Risk of Cognitive Decline and Dementia Among Older Adults. J Am Heart Assoc. 2021 Jul 6;10(13):e019613. doi: 10.1161/JAHA.120.019613. Epub 2021 Jun 26.
Neumann JT, Riaz M, Bakshi A, Polekhina G, Thao LTP, Nelson MR, Woods RL, Abraham G, Inouye M, Reid CM, Tonkin AM, Williamson JD, Donnan GA, Brodtmann A, Cloud GC, McNeil JJ, Lacaze P. Predictive Performance of a Polygenic Risk Score for Incident Ischemic Stroke in a Healthy Older Population. Stroke. 2021 Aug;52(9):2882-2891. doi: 10.1161/STROKEAHA.120.033670. Epub 2021 May 27.
Lockery JE, Broder JC, Ryan J, Stewart AC, Woods RL, Chong TT, Cloud GC, Murray A, Rigby JD, Shah R, Storey E, Ward SA, Wolfe R, Reid CM, Collyer TA, Ernst ME; ASPREE Investigator Group, ASPREE Investigator Group listed on www.aspree.org. A Cohort Study of Anticholinergic Medication Burden and Incident Dementia and Stroke in Older Adults. J Gen Intern Med. 2021 Jun;36(6):1629-1637. doi: 10.1007/s11606-020-06550-2. Epub 2021 Mar 22.
Islam RM, Bell RJ, Handelsman DJ, Robinson PJ, Wolfe R, Davis SR; ASPREE Investigator Group. Longitudinal changes over three years in sex steroid hormone levels in women aged 70 years and over. Clin Endocrinol (Oxf). 2021 Mar;94(3):443-448. doi: 10.1111/cen.14401. Epub 2021 Jan 2.
Ernst ME, Chowdhury EK, Beilin LJ, Margolis KL, Nelson MR, Wolfe R, Tonkin AM, Ryan J, Woods RL, McNeil JJ, Reid CM; ASPREE Investigator Group. Long-Term Blood Pressure Variability and Risk of Cardiovascular Disease Events Among Community-Dwelling Elderly. Hypertension. 2020 Dec;76(6):1945-1952. doi: 10.1161/HYPERTENSIONAHA.120.16209. Epub 2020 Nov 2.
Lockery JE, Ernst ME, Broder JC, Orchard SG, Murray A, Nelson MR, Stocks NP, Wolfe R, Reid CM, Liew D, Woods RL; ASPREE Investigator Group. Prescription Medication Use in Older Adults Without Major Cardiovascular Disease Enrolled in the Aspirin in Reducing Events in the Elderly (ASPREE) Clinical Trial. Pharmacotherapy. 2020 Oct;40(10):1042-1053. doi: 10.1002/phar.2461.
Orchard ER, Ward PGD, Chopra S, Storey E, Egan GF, Jamadar SD. Neuroprotective Effects of Motherhood on Brain Function in Late Life: A Resting-State fMRI Study. Cereb Cortex. 2021 Jan 5;31(2):1270-1283. doi: 10.1093/cercor/bhaa293.
Mahady SE, Margolis KL, Chan A, Polekhina G, Woods RL, Wolfe R, Nelson MR, Lockery JE, Wood EM, Reid C, Ernst ME, Murray A, Thao L, McNeil JJ. Major GI bleeding in older persons using aspirin: incidence and risk factors in the ASPREE randomised controlled trial. Gut. 2021 Apr;70(4):717-724. doi: 10.1136/gutjnl-2020-321585. Epub 2020 Aug 3.
Orchard SG, Lockery JE, Gibbs P, Polekhina G, Wolfe R, Zalcberg J, Haydon A, McNeil JJ, Nelson MR, Reid CM, Kirpach B, Murray AM, Woods RL; ASPREE Investigator Group. Cancer history and risk factors in healthy older people enrolling in the ASPREE clinical trial. Contemp Clin Trials. 2020 Sep;96:106095. doi: 10.1016/j.cct.2020.106095. Epub 2020 Jul 31.
Orchard ER, Ward PGD, Sforazzini F, Storey E, Egan GF, Jamadar SD. Relationship between parenthood and cortical thickness in late adulthood. PLoS One. 2020 Jul 28;15(7):e0236031. doi: 10.1371/journal.pone.0236031. eCollection 2020.
Ward PGD, Orchard ER, Oldham S, Arnatkeviciute A, Sforazzini F, Fornito A, Storey E, Egan GF, Jamadar SD. Individual differences in haemoglobin concentration influence bold fMRI functional connectivity and its correlation with cognition. Neuroimage. 2020 Nov 1;221:117196. doi: 10.1016/j.neuroimage.2020.117196. Epub 2020 Jul 25.
Ernst ME, Chowdhury EK, Nelson MR, Reid CM, Margolis KL, Beilin L, Stocks NP, Murray AM, Wolfe R, Lockery JE, Orchard SG, Woods RL, McNeil JJ; ASPREE Investigator Group. Antihypertensive medication use and blood pressure control among treated older adults. J Clin Hypertens (Greenwich). 2020 Aug;22(8):1406-1414. doi: 10.1111/jch.13934. Epub 2020 Jul 15.
Davis SR, Martinez-Garcia A, Robinson PJ, Handelsman DJ, Desai R, Wolfe R, Bell RJ; ASPREE Investigator Group. Estrone Is a Strong Predictor of Circulating Estradiol in Women Age 70 Years and Older. J Clin Endocrinol Metab. 2020 Sep 1;105(9):e3348-54. doi: 10.1210/clinem/dgaa429.
Berk M, Woods RL, Nelson MR, Shah RC, Reid CM, Storey E, Fitzgerald S, Lockery JE, Wolfe R, Mohebbi M, Dodd S, Murray AM, Stocks N, Fitzgerald PB, Mazza C, Agustini B, McNeil JJ. Effect of Aspirin vs Placebo on the Prevention of Depression in Older People: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Oct 1;77(10):1012-1020. doi: 10.1001/jamapsychiatry.2020.1214.
Ryan J, Storey E, Murray AM, Woods RL, Wolfe R, Reid CM, Nelson MR, Chong TTJ, Williamson JD, Ward SA, Lockery JE, Orchard SG, Trevaks R, Kirpach B, Newman AB, Ernst ME, McNeil JJ, Shah RC; ASPREE Investigator Group. Randomized placebo-controlled trial of the effects of aspirin on dementia and cognitive decline. Neurology. 2020 Jul 21;95(3):e320-e331. doi: 10.1212/WNL.0000000000009277. Epub 2020 Mar 25.
Ryan J, Woods RL, Murray AM, Shah RC, Britt CJ, Reid CM, Wolfe R, Nelson MR, Lockery JE, Orchard SG, Trevaks RE, Chong TJ, McNeil JJ, Storey E; ASPREE Investigator Group. Normative performance of older individuals on the Hopkins Verbal Learning Test-Revised (HVLT-R) according to ethno-racial group, gender, age and education level. Clin Neuropsychol. 2021 Aug;35(6):1174-1190. doi: 10.1080/13854046.2020.1730444. Epub 2020 Feb 26.
Lockery JE, Rigby J, Collyer TA, Stewart AC, Woods RL, McNeil JJ, Reid CM, Ernst ME; ASPREE Investigator Group. Optimising medication data collection in a large-scale clinical trial. PLoS One. 2019 Dec 27;14(12):e0226868. doi: 10.1371/journal.pone.0226868. eCollection 2019.
Chowdhury EK, Nelson MR, Ernst ME, Margolis KL, Beilin LJ, Johnston CI, Woods RL, Murray AM, Wolfe R, Storey E, Shah RC, Lockery JE, Tonkin AM, Newman AB, Williamson JD, Abhayaratna WP, Stocks NP, Fitzgerald SM, Orchard SG, Trevaks RE, Donnan GA, Grimm R, McNeil JJ, Reid CM; ASPREE Investigator Group. Factors Associated With Treatment and Control of Hypertension in a Healthy Elderly Population Free of Cardiovascular Disease: A Cross-sectional Study. Am J Hypertens. 2020 Apr 1;33(4):350-361. doi: 10.1093/ajh/hpz192.
McNeil JJ, Wolfe R, Woods RL, Tonkin AM, Donnan GA, Nelson MR, Reid CM, Lockery JE, Kirpach B, Storey E, Shah RC, Williamson JD, Margolis KL, Ernst ME, Abhayaratna WP, Stocks N, Fitzgerald SM, Orchard SG, Trevaks RE, Beilin LJ, Johnston CI, Ryan J, Radziszewska B, Jelinek M, Malik M, Eaton CB, Brauer D, Cloud G, Wood EM, Mahady SE, Satterfield S, Grimm R, Murray AM; ASPREE Investigator Group. Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly. N Engl J Med. 2018 Oct 18;379(16):1509-1518. doi: 10.1056/NEJMoa1805819. Epub 2018 Sep 16.
McNeil JJ, Woods RL, Nelson MR, Reid CM, Kirpach B, Wolfe R, Storey E, Shah RC, Lockery JE, Tonkin AM, Newman AB, Williamson JD, Margolis KL, Ernst ME, Abhayaratna WP, Stocks N, Fitzgerald SM, Orchard SG, Trevaks RE, Beilin LJ, Donnan GA, Gibbs P, Johnston CI, Ryan J, Radziszewska B, Grimm R, Murray AM; ASPREE Investigator Group. Effect of Aspirin on Disability-free Survival in the Healthy Elderly. N Engl J Med. 2018 Oct 18;379(16):1499-1508. doi: 10.1056/NEJMoa1800722. Epub 2018 Sep 16.
McNeil JJ, Nelson MR, Woods RL, Lockery JE, Wolfe R, Reid CM, Kirpach B, Shah RC, Ives DG, Storey E, Ryan J, Tonkin AM, Newman AB, Williamson JD, Margolis KL, Ernst ME, Abhayaratna WP, Stocks N, Fitzgerald SM, Orchard SG, Trevaks RE, Beilin LJ, Donnan GA, Gibbs P, Johnston CI, Radziszewska B, Grimm R, Murray AM; ASPREE Investigator Group. Effect of Aspirin on All-Cause Mortality in the Healthy Elderly. N Engl J Med. 2018 Oct 18;379(16):1519-1528. doi: 10.1056/NEJMoa1803955. Epub 2018 Sep 16.
Margolis KL, Mahady SE, Nelson MR, Ives DG, Satterfield S, Britt C, Ekram S, Lockery J, Schwartz EC, Woods RL, McNeil JJ, Wood EM. Development of a standardized definition for clinically significant bleeding in the ASPirin in Reducing Events in the Elderly (ASPREE) trial. Contemp Clin Trials Commun. 2018 May 22;11:30-36. doi: 10.1016/j.conctc.2018.05.015. eCollection 2018 Sep.
Ryan J, Woods RL, Britt C, Murray AM, Shah RC, Reid CM, Kirpach B, Wolfe RS, Nelson MR, Lockery JE, Orchard SG, Trevaks RE, McNeil JJ, Storey E; ASPREE Investigator Group. Normative performance of healthy older individuals on the Modified Mini-Mental State (3MS) examination according to ethno-racial group, gender, age, and education level. Clin Neuropsychol. 2019 May;33(4):779-797. doi: 10.1080/13854046.2018.1488996. Epub 2018 Jul 5.
Wolfe R, Murray AM, Woods RL, Kirpach B, Gilbertson D, Shah RC, Nelson MR, Reid CM, Ernst ME, Lockery J, Donnan GA, Williamson J, McNeil JJ. The aspirin in reducing events in the elderly trial: Statistical analysis plan. Int J Stroke. 2018 Apr;13(3):335-338. doi: 10.1177/1747493017741383. Epub 2017 Nov 7.
Ward SA, Storey E, Woods RL, Hamilton GS, Kawasaki R, Janke AL, Naughton MT, O'Donoghue F, Wolfe R, Wong TY, Reid CM, Abhayaratna WP, Stocks N, Trevaks R, Fitzgerald S, Hodgson LAB, Robman L, Workman B, McNeil JJ; ASPREE Study Group. The Study of Neurocognitive Outcomes, Radiological and Retinal Effects of Aspirin in Sleep Apnoea- rationale and methodology of the SNORE-ASA study. Contemp Clin Trials. 2018 Jan;64:101-111. doi: 10.1016/j.cct.2017.10.016. Epub 2017 Oct 31.
Reid CM, Storey E, Wong TY, Woods R, Tonkin A, Wang JJ, Kam A, Janke A, Essex R, Abhayaratna WP, Budge MM; ASPREE Study Group. Aspirin for the prevention of cognitive decline in the elderly: rationale and design of a neuro-vascular imaging study (ENVIS-ion). BMC Neurol. 2012 Feb 8;12:3. doi: 10.1186/1471-2377-12-3.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01038583