Clinical trial · Observational
Aspirin in Reducing Events in the Elderly
NCT01038583CI-TRIAL-00051047ASPREEunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bleeding | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Dementia | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Functional Disability | — | UNRESOLVED | — |
| Heart Disease | — | UNRESOLVED | — |
| Stroke | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 100 mg enteric-coated aspirin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Aspirin
- description
- 100 mg enteric-coated aspirin
- interventionNames
- Drug: 100 mg enteric-coated aspirin
- label
- Placebo
- description
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- The primary endpoint is death from any cause or incident, dementia or persistent physical disability.
- timeFrame
- every 6 months
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (64)
- BACKGROUNDBarker 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 26002770
- BACKGROUNDASPREE 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 24113028
- DERIVEDZhou Z, Yu C, Lacaze P, Wolfe R, Tonkin AM, Zhu C, Woods RL, Zheng J, Neumann JT, Nelson MR, Tran C, Beilin L, Tian F, Qiu P, Ryan J. Identifying Risk-De-Escalating Markers in PREVENT-Defined Intermediate-Risk Older Adults: Insights From ASPREE. Circ Popul Health Outcomes. 2026 Jul 2:e013687. doi: 10.1161/CIRCOUTCOMES.126.013687. Online ahead of print. PMID 42389765
- DERIVEDYu C, Hussain SM, Fransquet PD, Tran C, Tonkin AM, Nelson MR, Reid CM, Neumann JT, Williamson JD, Eaton CB, Hand P, Donnan GA, Brodtmann A, Cloud GC, McNeil JJ, Lacaze P. Polygenic Risk Identifies Older Adults Who May Benefit From Aspirin for the Primary Prevention of Ischemic Stroke. Stroke. 2026 Jul;57(7):2098-2107. doi: 10.1161/STROKEAHA.125.054979. Epub 2026 May 8. PMID 42100829
- DERIVEDRobb C, Carr PR, Ball J, Polekhina G, Clayton-Chubb D, George ES, Fitzpatrick J, Beilin LJ, Newman AB, Owen A, Orchard SG, Tran C, Ryan J, McNeil JJ. Association of Combined Lifestyle Behaviors With Healthspan in Older Adults. J Am Geriatr Soc. 2026 Jun;74(6):1614-1625. doi: 10.1111/jgs.70426. Epub 2026 May 7. PMID 42095703
- DERIVEDAbhayaratna WP, Reid CM, Webb KL, Wolfe R, Trevaks RE, Robman L, Ward SA, Law M, Sinclair B, Kolbe S, Budge MM, Wong TY, Tonkin A, McNeil JJ, Storey E, Woods RL. The effects of daily low-dose aspirin on white matter hyperintensity lesions and retinal vascular calibre in healthy older adults: the ENVIS-ion exploratory neuroimaging substudy of the ASPREE randomised clinical trial. Lancet Healthy Longev. 2026 Feb;7(2):100815. doi: 10.1016/j.lanhl.2025.100815. Epub 2026 Feb 14.