STAREEA Study of STAtins for Reducing Events in the Elderly (STAREE)
Atorvastatin
+ Placebo (for Atorvastatin)
Mental Disorders+10
+ Brain Diseases
+ Cardiovascular Diseases
Prevention Study
Summary
Study start date: July 1, 2015
Actual date on which the first participant was enrolled.Statin therapy has been shown to reduce the risk of vascular events in younger individuals with manifest atherosclerotic disease or at high risk of vascular events. However, data derived from meta-analyses of existing trials suggests that the efficacy of statins may decline sharply amongst those over 70-75 years of age. Insufficient patients of this age group have been included in major trials to be certain of the benefit. Within this age group part of the benefit of statin therapy may be offset by adverse effects including myopathy, development of diabetes, cancer and cognitive impairment, all of which are more prevalent in the elderly in any event. The use of statins in the over 70 age group raises fundamental questions about the purpose of preventive drug therapy in this age group. When a preventive agent is used in the context of competing mortality, polypharmacy and a higher incidence of adverse effects its use should be justified by an improvement in quality of life or some other composite measure that demonstrates that the benefit outweighs other factors. STAREE will determine whether taking daily statin therapy (40 mg atorvastatin) will extend the length of a disability-free life, determined from survival outside permanent residential care, in healthy participants aged 70 years and above.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.9971 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Men and women aged ≥70 years living independently in the community * Willing and able to provide informed consent and accept the study requirements (Note: competent physical ability to participate in the trial is assessed using the KATZ ADL questionnaire) Exclusion Criteria: A history of cardiovascular disease (defined as myocardial infarction, stroke, peripheral vascular disease, angina, transient ischaemic attack, coronary artery angioplasty and/or stenting, coronary artery bypass grafting, carotid stenosis, abdominal aortic aneurysm or heart failure), * A history of dementia or a 3MS score \<78 on screening, * A history of diabetes, * Total cholesterol \>7.5 mmol/L, * Moderate or severe chronic kidney disease (persistent proteinuria (Urine albumin:creatinine ratio \>30mg/mmol or Urine protein:creatinine ratios \>45 mg/mmol)45 and/or eGFR \<45ml/min/1.73m2), * Moderate or severe liver disease (persistent elevations of transaminases of more than 3 times the upper limit of the normal laboratory reference range), * Serious inter-current illness likely to cause death within the next 5 years such as terminal cancer or obstructive airways disease, * Current participation in a clinical trial, * Absolute contraindication to statin therapy, * Current use of statin therapy or other lipid lowering therapy for primary prevention and unwilling to stop therapy, * Current long term or permanent use of the following cytochrome P450 (CYP) 3A4 inhibitors : Amiodarone, Boceprevir, Cimetidine, Cyclosporin, Danazol, Fosamprenavir, Indinavir, Lopinavir + Ritonavir, Erythromycin, Fluconazole, Itraconazole, Ketoconazole.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 6 locations
Victoria
Melbourne, AustraliaSouth Australia
Adelaide, AustraliaQueensland
Brisbane, Australia