STAREE is a clinical research study that is investigating whether a cholesterol lowering medication known as a statin can prolong good health and maintain independence amongst older people. STAREE will also investigate whether statin treatment can reduce the need for permanent residential care in this age group.
It is thought that statins may reduce decline in physical and mental function as well as reducing the incidence of heart disease, stroke and dementia. Therefore, statin treatment may help to preserve healthy, independent living for longer. All drugs, including statins, have side-effects. Most side-effects of statins are mild and temporary. However, it is not known if the benefits from taking statins outweigh the risk of adverse events in older people. STAREE will be the first clinical trial to investigate this.
You can take part in this study if you are aged 70 years or over, in good health and have no prior history of any of heart disease, stroke or diabetes.
If you would like to participate in this study, you will be invited for a visit with STAREE staff at your GP practice. During this visit:
- STAREE staff will explain what participation in STAREE involves;
- STAREE staff will ask you about your medical history and current medication use;
- You will be able to ask STAREE staff any questions you have about the study - if you decide to participate you will be asked to give your formal consent and will be given a pathology request form for blood and urine samples.
Once you have consented to participate in the study, you will be asked to take a tablet for 4 weeks and attend a second visit with the STAREE research staff.
If you agree to continue in the study:
- You will be required to take statin or placebo tablets every day for an average of five years.
- STAREE staff will regularly phone you during the study to discuss ongoing medical conditions and medication use.
- You will be required to attend annual study visits where you will undergo memory and physical ability tests, physical measurements, and update us on your medical conditions and medication use.
By participating in this study, you will help us learn more about the benefits and risks of statin use in people aged 70 years and over. This knowledge will guide the use of statins by millions of people worldwide. Participation of individuals such as you is vital for a successful study.
The trial has ethics approval from Monash University Human Research Ethics Committee, the RACGP National Research and Evaluation Committee, Curtin University Human Research Ethics Committee, University of Tasmania Human Research Ethics Committee and The University of Newcastle Human Research Ethics Committee.