NCT01038583

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 Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
19,114

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
2 countries

47 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

April 5, 2021

Status Verified

April 1, 2021

Enrollment Period

7.9 years

First QC Date

December 21, 2009

Last Update Submit

April 2, 2021

Conditions

Keywords

AspirinPreventionHealthyOver 70 years oldASPREEAspirin in Reducing Events in the ElderlyAustraliaFunctional disabilityDementiaHeart Disease/ StrokeCancerBleeding

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is death from any cause or incident, dementia or persistent physical disability.

    Dementia will be diagnosed based on DSM-IV criteria. Significant physical disability will be defined as a confirmed, and persisting for at least 6 months, self-report of 'a lot of difficulty', or 'inability to perform independently' any one of the 6 Katz basic Activities of Daily Living (ADLs).75

    every 6 months

Secondary Outcomes (8)

  • All-cause mortality

    every 6 months

  • 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

    every 6 months

  • Fatal and non-fatal cancer, excluding non-melanoma skin cancer

    every 6 months

  • Dementia

    every 6 months

  • Mild Cognitive Impairment (MCI; assessed using the Modified Mini-Mental State Examination or 3MS 70 and other cognitive function measures - see below)

    every 6 months

  • +3 more secondary outcomes

Study Arms (2)

Aspirin

100 mg enteric-coated aspirin

Drug: 100 mg enteric-coated aspirin

Placebo

Placebo

Drug: Placebo

Interventions

100 mg enteric-coated aspirin, taken daily

Aspirin

100 mg enteric-coated placebo

Placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (47)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Palo Alto Medical Foundation Research Institute

Palo Alto, California, 94301, United States

Location

Howard University

Washington D.C., District of Columbia, 20060, United States

Location

University of Florida Department of Aging and Geriatrics

Gainesville, Florida, 32611, United States

Location

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

Location

Emory/ Atlanta VAMC

Atlanta, Georgia, 30322, United States

Location

Georgia Health Sciences University

Augusta, Georgia, 30912, United States

Location

Rush Alzheimer's Disease Center

Chicago, Illinois, 60612, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66106, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Mary Bird Perkins Our Lady of the Lake Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

LSU Health Sciences- New Orleans

New Orleans, Louisiana, 70112, United States

Location

Tulane Medical Center

New Orleans, Louisiana, 70112, United States

Location

LSU Health Sciences- Shreveport

Shreveport, Louisiana, 71130, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Detroit Clinical Research Center

Novi, Michigan, 48377, United States

Location

HealthPartners Research Institute

Minneapolis, Minnesota, 55425, United States

Location

Phalen Village Clinic

Saint Paul, Minnesota, 55106, United States

Location

Central Jersey Medical Center

Elizabeth, New Jersey, 07202, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Wake Forest University Baptist Medical Center

Greensboro, North Carolina, 27408, United States

Location

The Brody School of Medicine at ECU

Greenville, North Carolina, 27834, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

University of Pittsburgh Health Sciences Research Center

Pittsburgh, Pennsylvania, 15260, United States

Location

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, 02860, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38105, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

University of TX Medical Branch

Galveston, Texas, 77555, United States

Location

Regional Academic Health Center

Harlingen, Texas, 78550, United States

Location

UT Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Clinical Trials Unit, The Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

Illawarra Health and Medical Research Institute, University of Wollongong

Wollongong, New South Wales, 2522, Australia

Location

Discipline of General Practice, School of Population Health, University of Adelaide

Adelaide, South Australia, 5005, Australia

Location

Greater Green Triangle University

Mount Gambier, South Australia, 5290, Australia

Location

University of Tasmania Rural Clinical School

Burnie, Tasmania, 7320, Australia

Location

The Menzies Institute for Medical Research, University of Tasmania

Hobart, Tasmania, 7000, Australia

Location

University of Tasmania Newnham Campus

Launceston, Tasmania, 7250, Australia

Location

Bendigo Regional Clinical School

Bendigo, Victoria, 3550, Australia

Location

Geelong Hospital

Geelong, Victoria, 3220, Australia

Location

Monash Mildura Regional Clinical School

Mildura, Victoria, 3500, Australia

Location

University of Ballarat

Mount Helen, Victoria, 3350, Australia

Location

Monash Gippsland Regional Clinical School

Traralgon, Victoria, 3844, Australia

Location

The South West Alliance of Rural Health (SWARH)

Warrnambool, Victoria, 3280, Australia

Location

Gateway Community Health

Wodonga, Victoria, 3690, Australia

Location

Related Publications (58)

  • 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.

    PMID: 26002770BACKGROUND
  • 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.

    PMID: 24113028BACKGROUND
  • McQuilten ZK, Thao LTP, Bick AG, Byars S, Chan AT, Ford L, Leichter A, McNeil JJ, Murray AM, Murphy AJ, Orchard SG, Phung J, Ramshaw HS, Singh J, Tonkin AM, Umar A, Wolfe R, Wood EM, Woods RL, Lacaze P, Curtis DJ. Clonal Hematopoiesis and Cardiovascular Disease and Bleeding Risk and the Effectiveness of Aspirin. JAMA Cardiol. 2025 Dec 1;10(12):1257-1266. doi: 10.1001/jamacardio.2025.3756.

  • Thao LTP, Nguyen TL, Singh J, Byars SG, Bick AG, Ford L, Gibbs P, McNeil JJ, Murray AM, Orchard SG, Phung J, Umar A, Wood EM, Woods RL, Lacaze P, Chan AT, Curtis DJ, McQuilten ZK, Wolfe R. Low-Dose Aspirin for Individualized Cancer Prevention in Older Adults: A Secondary Analysis of the ASPREE Randomized Clinical Trial. JAMA Oncol. 2025 Nov 1;11(11):1348-1355. doi: 10.1001/jamaoncol.2025.3593.

  • Sheets KM, Webb KL, Woods RL, Orchard SG, Beilin L, Fravel MA, Reid CM, Polkinghorne KR, Wolfe R, Zhou Z, Ryan J, Murray AM, Ernst ME. Long-Term Blood Pressure Variability and Physical Performance in Older Adults. J Clin Hypertens (Greenwich). 2025 Sep;27(9):e70139. doi: 10.1111/jch.70139.

  • Sultana F, Islam RM, Davis SR. Associations between declining testosterone concentrations and cognitive performance in community-dwelling older Australian women: a prospective cohort study. Climacteric. 2025 Aug 14:1-7. doi: 10.1080/13697137.2025.2539854. Online ahead of print.

  • Brodtmann A, Cheng N, Werden E, Neumann J, Robb C, Fitzgerald SM, Wolfe R, Tonkin AM, Orchard SG, Ryan J, Woods RL, Gao C, McNeil JJ. Cognitive trajectories and incident atrial fibrillation in the ASPREE cohort. medRxiv [Preprint]. 2025 Aug 1:2025.08.01.25332579. doi: 10.1101/2025.08.01.25332579.

  • Fravel MA, Ernst ME, Woods RL, Orchard SG, Ganjali S, Wetmore JB, Reid C, Ryan J, Polkinghorne KR, Wolfe R, Nelson MR, Zoungas S, Zhou Z. Performance of the American Heart Association PREVENT Cardiovascular Risk Equations in Older Adults. Circ Cardiovasc Qual Outcomes. 2025 Jun;18(6):e011719. doi: 10.1161/CIRCOUTCOMES.124.011719. Epub 2025 Apr 28.

  • Ward SA, Storey E, Naughton MT, Wolfe R, Hamilton GS, Law M, Kawasaki R, Abhayaratna WP, Webb KL, O'Donoghue FJ, Gasevic D, Stocks NP, Trevaks RE, Robman LD, Kolbe S, Fitzgerald SM, Orchard SG, Wong TY, McNeil JJ, Reid CM, Sinclair B, Woods RL. Obstructive sleep apnea and cerebral small vessel disease in community-based older people: an aspirin in reducing events in the elderly imaging substudy. Sleep. 2025 Feb 10;48(2):zsae204. doi: 10.1093/sleep/zsae204.

  • Zhou Z, Webb KL, Nelson MR, Woods RL, Ernst ME, Murray AM, Chan AT, Tonkin A, Reid CM, Orchard SG, Kirpach B, Shah RC, Stocks N, Broder JC, Wolfe R. Short- and long-term impact of aspirin cessation in older adults: a target trial emulation. BMC Med. 2024 Jul 29;22(1):306. doi: 10.1186/s12916-024-03507-8.

  • Wang Y, Islam RM, Hussain SM, McNeil JJ, Davis SR. Associations Between Blood Concentrations of Sex Hormones and Physical Function in Community-Dwelling Older Women: A Prospective Cohort Study. J Gerontol A Biol Sci Med Sci. 2024 Apr 1;79(4):glad287. doi: 10.1093/gerona/glad287.

  • Zhou Z, Tonkin AM, Curtis AJ, Murray A, Zhu C, Reid CM, Williamson JD, Ryan J, McNeil JJ, Beilin LJ, Ernst ME, Stocks N, Lacaze P, Shah RC, Woods RL, Wolfe R, Gall S, Zoungas S, Orchard SG, Nelson MR. Low-Density-Lipoprotein Cholesterol and Mortality Outcomes Among Healthy Older Adults: A Post Hoc Analysis of ASPREE Trial. J Gerontol A Biol Sci Med Sci. 2024 Apr 1;79(4):glad268. doi: 10.1093/gerona/glad268.

  • Fravel MA, Ernst ME, Woods RL, Beilin L, Zhou Z, Orchard SG, Chowdhury E, Reid CM, Saifuddin Ekram A, Espinoza SE, Nelson MR, Stocks N, Polkinghorne KR, Wolfe R, Ryan J. Long-term blood pressure variability and frailty risk in older adults. J Hypertens. 2024 Feb 1;42(2):244-251. doi: 10.1097/HJH.0000000000003599. Epub 2023 Nov 20.

  • Yu C, Bakshi A, Watts GF, Renton AE, Fulton-Howard B, Goate AM, Natarajan P, Chasman DI, Robman L, Woods RL, Guymer R, Wolfe R, Thao LTP, McNeil JJ, Tonkin AM, Nicholls SJ, Lacaze P. Genome-Wide Association Study of Cardiovascular Resilience Identifies Protective Variation in the CETP Gene. J Am Heart Assoc. 2023 Nov 7;12(21):e031459. doi: 10.1161/JAHA.123.031459. Epub 2023 Nov 6.

  • Salih A, Ardissino M, Wagen AZ, Bard A, Szabo L, Ryten M, Petersen SE, Altmann A, Raisi-Estabragh Z. Genome-Wide Association Study of Pericardial Fat Area in 28 161 UK Biobank Participants. J Am Heart Assoc. 2023 Nov 7;12(21):e030661. doi: 10.1161/JAHA.123.030661. Epub 2023 Oct 27.

  • Islam RM, Bell RJ, Berk M, Handelsman DJ, McNeil JJ, Wolfe R, Woods RL, Davis SR. Associations between low sex hormone concentrations and depression in older women: An observational study. Maturitas. 2023 Oct;176:107822. doi: 10.1016/j.maturitas.2023.107822. Epub 2023 Aug 4.

  • McQuilten ZK, Thao LTP, Pasricha SR, Artz AS, Bailey M, Chan AT, Cohen HJ, Lockery JE, Murray AM, Nelson MR, Schneider HG, Wolfe R, Woods RL, Wood EM, McNeil JJ. Effect of Low-Dose Aspirin Versus Placebo on Incidence of Anemia in the Elderly : A Secondary Analysis of the Aspirin in Reducing Events in the Elderly Trial. Ann Intern Med. 2023 Jul;176(7):913-921. doi: 10.7326/M23-0675. Epub 2023 Jun 20.

  • Lockery JE, Collyer TA, Woods RL, Orchard SG, Murray A, Nelson MR, Stocks NP, Wolfe R, Moran C, Ernst ME; ASPREE Investigator Group. Potentially inappropriate medication use is associated with increased risk of incident disability in healthy older adults. J Am Geriatr Soc. 2023 Aug;71(8):2495-2505. doi: 10.1111/jgs.18353. Epub 2023 Apr 11.

  • Carr PR, Webb KL, Neumann JT, Thao LTP, Beilin LJ, Ernst ME, Fitzgibbon B, Gasevic D, Nelson MR, Newman AB, Orchard SG, Owen A, Reid CM, Stocks NP, Tonkin AM, Woods RL, McNeil JJ. Associations of body size with all-cause and cause-specific mortality in healthy older adults. Sci Rep. 2023 Mar 7;13(1):3799. doi: 10.1038/s41598-023-29586-w.

  • Orchard SG, Lockery JE, Broder JC, Ernst ME, Espinoza S, Gibbs P, Wolfe R, Polekhina G, Zoungas S, Loomans-Kropp HA, Woods RL; ASPREE Investigator Group. Association of metformin, aspirin, and cancer incidence with mortality risk in adults with diabetes. JNCI Cancer Spectr. 2023 Mar 1;7(2):pkad017. doi: 10.1093/jncics/pkad017.

  • Sultana F, Davis SR, Murray AM, Woods RL, McNeil JJ, Islam RM. Sex hormones, SHBG and cognitive performance among older Australian women: an observational study. Climacteric. 2023 Apr;26(2):121-128. doi: 10.1080/13697137.2023.2166824. Epub 2023 Jan 30.

  • Saifuddin Ekram ARM, Espinoza SE, Ernst ME, Ryan J, Beilin L, Stocks NP, Ward SA, McNeil JJ, Shah RC, Woods RL. The Association between Metabolic Syndrome, Frailty and Disability-Free Survival in Healthy Community-dwelling Older Adults. J Nutr Health Aging. 2023;27(1):1-9. doi: 10.1007/s12603-022-1860-2.

  • Ekram ARMS, Ryan J, Espinoza SE, Newman AB, Murray AM, Orchard SG, Fitzgerald SM, McNeil JJ, Ernst ME, Woods RL. The Association between Frailty and Dementia-Free and Physical Disability-Free Survival in Community-Dwelling Older Adults. Gerontology. 2023;69(5):549-560. doi: 10.1159/000528984. Epub 2023 Jan 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.

  • Polkinghorne KR, Wetmore JB, Thao LTP, Wolfe R, Woods RL, Ernst ME, Nelson MR, Reid CM, Shah RC, McNeil JJ, Murray AM. Effect of Aspirin on CKD Progression in Older Adults: Secondary Analysis From the ASPREE Randomized Clinical Trial. Am J Kidney Dis. 2022 Dec;80(6):810-813. doi: 10.1053/j.ajkd.2022.02.019. Epub 2022 Apr 14. No abstract available.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

DementiaHeart DiseasesStrokeNeoplasmsHemorrhageDepression

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCardiovascular DiseasesCerebrovascular DisordersVascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Anne Murray, MD, MSc

    Berman Center for Outcomes and Clinical Research

    PRINCIPAL INVESTIGATOR
  • John McNeil, MBBS, PHD

    Monash University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2009

First Posted

December 24, 2009

Study Start

January 1, 2010

Primary Completion

December 1, 2017

Study Completion

April 1, 2024

Last Updated

April 5, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

Working with ASPREE - for Data Access requests Monitored secure portal - development underway

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
2019
Access Criteria
Will be defined in the Working with ASPREE document

Locations