Clinical trial NCT01038583: Aspirin in Reducing Events in the Elderly
Official title: Aspirin in Reducing Events in the Elderly
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Functional Disability
Dementia
Heart Disease
Stroke
Cancer
Bleeding
Depression
Keywords: Aspirin
Prevention
Healthy
Over 70 years old
ASPREE
Aspirin in Reducing Events in the Elderly
Australia
Functional disability
Dementia
Heart Disease/ Stroke
Cancer
Bleeding
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
name: Bayer
name: Monash University
name: Berman Center for Outcomes and Clinical Research
name: National Institute on Aging (NIA)
name: National Cancer Institute (NCI)
First posted: 2009-12-24
Enrollment: 19114
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men and women recruited from the US and Australia.

* African American and Hispanic persons age 65 or older in the US
* 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

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.

Detailed description: ASPREE BACKGROUND:

ASPREE (ASPirin in Reducing Events in the Elderly) is a joint US/Australian research project aiming to determine whether low-dose aspirin increases healthy life-span, defined as survival free of dementia and disability. ASPREE began in 2010 and completed recruitment in 2014. It is a randomized, double-blind, placebo-controlled, primary prevention trial of daily 100 mg of aspirin in a population of healthy older people in the United States (US) and Australia with a period of treatment averaging 4.5 years. ASPREE's primary outcome is length of survival free of dementia and disability and has secondary outcomes encompassing the major health issues related to aging. The trial involving 19,114 persons aged 70 and above (65 years and above for US minorities) is distinctive for its large size, methodological rigor and high participant retention rate in both countries.

ASPREE UNIQUE ASPECTS:

1. It is the first large scale trial to incorporate dementia-free and disability-free survival as a primary outcome. This is now recognized as an appropriate goal of treatment in a primary prevention population of this age group. Within a clinical trial context disability-free survival incorporates an estimate of the overall benefits and risks of aspirin in a single outcome measure.
2. It is one of the first primary prevention trials of aspirin to include cancer incidence, metastases or mortality as a pre-specified endpoint. Recent meta-analyses \[Rothwell et al 2010, 2011, 2012\] suggests that aspirin has a significant chemopreventive effect becoming evident after a period of 4+ years of aspirin treatment, but questions remain about the magnitude of benefit, and whether it applies to treatment of all cancers and to older people.
3. It will provide information about the impact of aspirin on a range of other conditions (e.g, dementia, CVD, stroke, depression, bleeding) where aspirin has been claimed to have benefit (or risks).

The intervention phase of the trial ended in June 2017 after the NIA determined that it was highly unlikely that aspirin would show a benefit on the overall primary outcome within the planned 5-year time frame. The study is now entering a data cleaning and analysis phase and it is anticipated that the primary results were published in September 2018.

Eligibility criteria: 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

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

Primary outcomes:
measure: The primary endpoint is death from any cause or incident, dementia or persistent physical disability.
timeFrame: every 6 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: every 6 months
measure: 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
timeFrame: every 6 months
measure: Fatal and non-fatal cancer, excluding non-melanoma skin cancer
timeFrame: every 6 months
measure: Dementia
timeFrame: every 6 months
measure: Mild Cognitive Impairment (MCI; assessed using the Modified Mini-Mental State Examination or 3MS 70 and other cognitive function measures - see below)
timeFrame: every 6 months
measure: Physical disability
timeFrame: every 6 months
measure: Major hemorrhagic events
timeFrame: every 6 months
measure: Depression
timeFrame: Annually
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation Research Institute
state: California
city: Washington
country: United States
facility: Howard University
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida Department of Aging and Geriatrics
state: Florida
city: Atlanta
country: United States
facility: Morehouse School of Medicine
state: Georgia
city: Atlanta
country: United States
facility: Emory/ Atlanta VAMC
state: Georgia
city: Augusta
country: United States
facility: Georgia Health Sciences University
state: Georgia
city: Chicago
country: United States
facility: Rush Alzheimer's Disease Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Our Lady of the Lake Cancer Center
state: Louisiana
city: New Orleans
country: United States
facility: LSU Health Sciences- New Orleans
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Sciences- Shreveport
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Novi
country: United States
facility: Detroit Clinical Research Center
state: Michigan
city: Minneapolis
country: United States
facility: HealthPartners Research Institute
state: Minnesota
city: Saint Paul
country: United States
facility: Phalen Village Clinic
state: Minnesota
city: Elizabeth
country: United States
facility: Central Jersey Medical Center
state: New Jersey
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Greensboro
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Greenville
country: United States
facility: The Brody School of Medicine at ECU
state: North Carolina
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Health Sciences Research Center
state: Pennsylvania
city: Pawtucket
country: United States
facility: Memorial Hospital of Rhode Island
state: Rhode Island
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Galveston
country: United States
facility: University of TX Medical Branch
state: Texas
city: Harlingen
country: United States
facility: Regional Academic Health Center
state: Texas
city: San Antonio
country: United States
facility: UT Health Science Center at San Antonio
state: Texas
city: Garran
country: Australia
facility: Clinical Trials Unit, The Canberra Hospital
state: Australian Capital Territory
city: Wollongong
country: Australia
facility: Illawarra Health and Medical Research Institute, University of Wollongong
state: New South Wales
city: Adelaide
country: Australia
facility: Discipline of General Practice, School of Population Health, University of Adelaide
state: South Australia
city: Mount Gambier
country: Australia
facility: Greater Green Triangle University
state: South Australia
city: Burnie
country: Australia
facility: University of Tasmania Rural Clinical School
state: Tasmania
city: Hobart
country: Australia
facility: The Menzies Institute for Medical Research, University of Tasmania
state: Tasmania
city: Launceston
country: Australia
facility: University of Tasmania Newnham Campus
state: Tasmania
city: Bendigo
country: Australia
facility: Bendigo Regional Clinical School
state: Victoria
city: Geelong
country: Australia
facility: Geelong Hospital
state: Victoria
city: Mildura
country: Australia
facility: Monash Mildura Regional Clinical School
state: Victoria
city: Mount Helen
country: Australia
facility: University of Ballarat
state: Victoria
city: Traralgon
country: Australia
facility: Monash Gippsland Regional Clinical School
state: Victoria
city: Warrnambool
country: Australia
facility: The South West Alliance of Rural Health (SWARH)
state: Victoria
city: Wodonga
country: Australia
facility: Gateway Community Health
state: Victoria
Study officials:
affiliation: Berman Center for Outcomes and Clinical Research
name: Anne Murray, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Monash University
name: John McNeil, MBBS, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.