A Placebo Controlled Trial of Low Dose Aspirin in the Elderly
Download the ASPREE Protocol (PDF, 290kb) (version 2.0 06-03-2008)
ASPREE (ASPirin in Reducing Events in the Elderly) is a large-scale, double-blind primary prevention trial of aspirin versus placebo over a 5 year treatment period in 19,000 healthy elderly people aged 70 years and over. Its purpose is to determine whether low dose aspirin will extend the duration of disability-free life in an ageing population. The study will examine whether the potential benefits of this drug (particularly the prevention of heart disease, stroke and dementia) outweigh the risks of severe bleeding in this age group.
Low dose aspirin therapy has been shown to reduce the risk of vascular events in a wide range of primary and secondary settings and there is increasing evidence of its potential to reduce the rate of intellectual decline in older individuals and also the incidence of colorectal cancer. However, part of the benefit of aspirin may be offset by a variety of adverse effects. The balance of risks and benefits of aspirin has not been established in older subjects.
The primary outcome of ASPREE is to determine whether 100 mg of daily aspirin prolongs life free of dementia or significant physical disability in healthy older individuals. Additional aims are to investigate aspirin's effects on cardiovascular and cerebrovascular events, cognitive decline, haemorrhagic stroke, gastrointestinal and other clinically significant bleeds, carcinoma incidence and quality of life.
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