STAREE, a randomised controlled trial of atorvastatin vs. placebo for disability free survival and adverse cardiovascular events in the over 70s.

Problem

Statin use for primary prevention is recommended based on absolute CVD event risk. Most aged individuals are at high risk but have not been included in clinical trials addressing the balance of risk and benefits of statins for CVD and other important health outcomes.

Approach

Recruitment of 18,000 participants is underway through the recruitment of general practitioners as co-investigators using the same model as the recently completed ASPREE study (N = 19,114). In summary clinical records are screened by eligibility criteria and letters of invitation from their own GP are sent to patients requesting they call a toll-free contact number. On calling participants are further screened and given an appointment with a research assistant at the practice. At this visit informed consent is obtained and eligibility is checked, which includes a placebo run-in. Compliance is confirmed at a follow-up visit in 4 weeks.

Findings

As of 25/2/19 more than 2700 GPs have enrolled as co-investigators in all Australian states. Around 176,000 letters have been sent, 14,036 telephone interviews conducted and 6,526 have consented to be in the trial at a face-to-face screening visit. 4,709 participants have been randomised into the trial.

Consequences

STAREE will address the evidence gap in statin use for primary prevention in the aged. It will either justify its already common use or eliminate another ineffective medication from a population already burdened with polypharmacy. An opportunity exists for the UK primary care sector to participate in this trial.