The risk/benefit ratio of using statins for cardiovascular (CV) primary prevention in elderly people has not been established. The main objectives of the present study are to assess the cost-effectiveness of statin cessation and to examine the non-inferiority of statin cessation in terms of mortality in patients aged 75 and over treated with statins for primary prevention. Methods The Statins In The Elderly (SITE) Study is an ongoing 3-year follow-up, open-label comparative multi-centre

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... ed clinical trial that is being conducted in two parallel groups in outpatient primary care offices. Participants meeting the following criteria are being included: people aged 75 years and older being treated with statins as primary prevention for CV events who provide informed consent. After randomisation, patients in the statin-cessation strategy are instructed to withdraw their treatment. In the comparison strategy, patients continue their statin treatment at the usual dosage. The cost-effectiveness of the statin-cessation strategy compared to continuing statins will be estimated through the incremental cost per quality-adjusted life years (QALY) gained at 36 months based on the perspective of the French healthcare system. Overall mortality will be the primary clinical endpoint. We assumed that the mortality rate at 3 years will be 15%. The sample size was computed to achieve 90% power in showing the noninferiority of statin cessation, assuming a non-inferiority margin of 5% of the between-group difference in overall mortality. In total, the SITE study will include 2,430 individuals. Discussion There is some debate regarding the value of statins in people over 75 years old, especially for primary prevention, due to a lack of evidence of their