ASPirin in Reducing Events in the Elderly - Protocol

ASPREE is a double-blind, randomized, placebo-controlled primary prevention trial designed to assess whether daily active treatment of 100 mg enteric-coated aspirin will extend the duration of disability-free life in healthy participants aged 70 years and above except for Hispanic and African American minority groups in the U.S. where the minimum age of entry is 65 years. The study will examine whether the potential benefits of low dose aspirin (particularly the prevention of heart disease, stroke, certain cancers and dementia) outweigh the risks (particularly severe gastrointestinal bleeding and hemorrhagic stroke) in this age group. Participants will be eligible for the trial if they do not have a current clinical indication for (i.e. overt cardiovascular disease) or contraindication to (i.e. allergy or increased risk of bleeding) aspirin, do not have dementia, disability, low hemoglobin levels, or have a condition that is likely to be fatal during the 5 years of the trial and are capable of providing informed consent. Nineteen thousand participants will be required to provide 90% power of a true relative risk benefit of 0.90 for the primary endpoint (a composite of all-cause mortality, incident dementia and persistent physical disability) in an intention-to-treat analysis with an average follow-up of 5 years. The trial has received financial support from the U.S. National Institute on Aging (part of the National Institutes of Health), the National Health and Medical Research Council of Australia, the National Heart Foundation of Australia and the Victorian Cancer Agency. Bayer Pharma AG provides in kind support through the provision of low dose aspirin and matching placebo. The study will be carried out in community settings in the U.S. and Australia. In the U.S., 2,500 participants will be recruited through clinical trials networks in regional hub settings. In Australia, recruitment of 16,500 participants will take place through general practices with the participant’s usual treating General Practitioner (GP) as co-investigator.