ASPREE-XT (ASPirin in Reducing Events in the Elderly eXTension) study.
The ASPREE study, an N of 19,114 randomised controlled trial of low dose aspirin vs. placebo, showed no benefit for disability free survival in the elderly. There was also an excess of mortality in those taking aspirin and this was almost entirely driven by cancer deaths. Systematic reviews of cancer outcomes for the benefit of cancer suggest benefits may only accrue over a decade or more and not the median 4.7 years of observation in the trial.
A post-trial cohort study to investigate long-term legacy effects of aspirin on disability free survival, dementia, cognitive impairment, mortality, fatal and non-fatal cancer, physical disability, depression and major haemorrhagic events. Concurrently these and other diseases of ageing can be studied in a healthy ageing cohort. Data will be collected and endpoints adjudicated as for the ASPREE study giving an enriched longitudinal dataset.
From the beginning of February 2018 to the end of February 2019, 13,829 have consented to ASPREE-XT (not including verbal consent) of a possible 17,099 (excluding those who had withdrawn or died during the ASPREE study).
This will provide an opportunity to monitor the health of an initial healthy aged population well into quite advanced age. It will provide essential data on the burden of diseases and their possible risk and protective factors, aetiology, possible potential therapies and effectiveness of current therapies through participant characteristics, exposures, behavioural, genetic and biomarker changes from ASPREE trial entry (2010-2014) until 2024.