# ASPREE (ASPirin in Reducing Events in the Elderly)

Source: https://onco.cc/trials/aspree/  
OnCo record `aspree` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

In healthy older people, daily low-dose aspirin did not extend disability-free life and, unexpectedly, was linked with more cancer deaths. It changed guidelines against routine aspirin in the elderly.

## Summary

19,114 participants followed for a median 4.7 years. Aspirin did not reduce disability-free survival (HR 1.01) or cardiovascular events, increased major haemorrhage (HR 1.38), and was associated with higher all-cause mortality (HR 1.14, 95% CI 1.01-1.29), driven by cancer deaths (HR 1.31, 95% CI 1.10-1.56), particularly from advanced or metastatic cancers. Extended follow-up did not show a later emergence of cancer prevention. The finding contradicts long-term follow-up of earlier aspirin trials in middle-aged adults and is unexplained; hypotheses include a different effect of aspirin on established late-life cancers. It was central to the US Preventive Services Task Force 2022 decision to withdraw the recommendation for aspirin to prevent colorectal cancer.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-08
- Registry id: NCT01038583
- Phase: 3
- Setting: Community-dwelling adults aged 70+ (65+ for US Black and Hispanic participants) without cardiovascular disease, dementia or disability: aspirin 100 mg/day vs placebo
- Sponsor: Monash University / NIH National Institute on Aging
- Enrolled: 19114
- Result: All-cause mortality HR 1.14; cancer mortality HR 1.31; no cancer prevention.
- Outcomes: Death from cancer: Aspirin 295 events vs Placebo 227 events, HR 1.31
- Replication: Discordant with pooled long-term follow-up of cardiovascular aspirin trials in younger adults (reduced colorectal cancer mortality); age-dependence of the aspirin effect is now the working explanation.

## Sources

- ClinicalTrials.gov NCT01038583: https://clinicaltrials.gov/study/NCT01038583
- Mortality results (NEJM 2018): https://doi.org/10.1056/NEJMoa1803955

## Connected records

- fronts: [Diet, Exercise & Lifestyle](https://onco.cc/fronts/nutrition-lifestyle/), [Prevention & Risk](https://onco.cc/fronts/prevention/)
- technologies: [Aspirin for cancer prevention and adjuvant therapy](https://onco.cc/technologies/aspirin-cancer-prevention/), [Chemoprevention & risk-reducing surgery](https://onco.cc/technologies/chemoprevention/)
- drugs: [Aspirin](https://onco.cc/drugs/aspirin/)
- terms: [Hazard ratio (HR)](https://onco.cc/terms/hazard-ratio/)
- bottlenecks: [Failures are hidden](https://onco.cc/bottlenecks/b-negative-results/), [Older and multimorbid patients are excluded and undertreated](https://onco.cc/bottlenecks/b-aging-comorbidity/)
- key papers: [Effect of Aspirin on All-Cause Mortality in the Healthy Elderly](https://onco.cc/key-papers/paper-mcneil-n-engl-j-med/)
- roadmaps: [Cancer prevention roadmap: tobacco control and vaccines → biomarker-guided chemoprevention → interception in carriers](https://onco.cc/roadmaps/prevention-roadmap/)

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