Study population and trial design
physical disability, dementia, CVD
CARDIOVASCULAR DISEASE, CVD, PHYSICAL DISABILITY, EVENTS, EVENTS
The ASPirin in Reducing Events in the Elderly (ASPREE) study was a large, randomized, double-blind, placebo-controlled trial investigating the effect of 100 mg aspirin on disability-free survival in apparently healthy men and women who were 70 years of age or older (or ≥ 65 years of age for African Americans and Hispanics in the US). All participants were required to be in good health, with no prior cardiovascular disease (CVD) events, dementia or major physical disability and expected to survive for at least five years. Details of the ASPREE trial and the primary results of the study have been published previouslyThe trial was conducted according to the Australian National Statement on Ethical Conduct in Human Research, the Australian Code for the Responsible Conduct of Research, the 2008 Declaration of Helsinki, and the International Conference on Harmonization Good Clinical Practice E6 and was approved by institutional review boards at all sites. All participants provided written informed consent. The ASPREE study is registered on ClinicalTrials.gov (Trial registration number: ASPREE ClinicalTrials.gov number NCT01038583, 24/12/2009) and the International Standard Randomised Controlled Trial Number Registry (ISRCTN83772183). This study was reviewed and approved by the Monash University Human Research Ethics Committee (Project No. 24743).