A Clinical Trial of STAtin Therapy for Reducing Events in the Elderly (STAREE)
Study Details
Study Description
Brief Summary
The STAREE study will examine whether treatment with statin (atorvastatin 40mg) compared with placebo will prolong overall survival or disability free survival amongst healthy elderly people (≥70 years).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Atorvastatin 40 mg atorvastatin (2 x 20 mg atorvastatin), taken orally once daily |
Drug: Atorvastatin
Atorvastatin 20 mg tablet
Other Names:
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| Placebo Comparator: Placebo Placebo (2 x 20 mg placebo) taken orally once daily |
Drug: Placebo (for Atorvastatin)
Inactive pill manufactured to mimic Atorvastatin 20 mg tablet
Other Names:
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Outcome Measures
Primary Outcome Measures
- (i) to death or development of dementia (as measured by cognitive function tests) or development of disability (as measured by the KATZ ADL test), or (ii) to a major fatal or non-fatal cardiovascular event. [Time from randomisation to a primary endpoint]
The primary endpoint is either the time from randomisation (i) to death or development of dementia (as measured by cognitive function tests) or development of disability (as measured by the KATZ ADL33 test), or (ii) to a major fatal or non-fatal cardiovascular event.
Secondary Outcome Measures
- Cardiovascular death [From date of randomisation until the date of a death to a cardiovascular cause]
Fatal cardiovascular events
- Fatal and Non-fatal Mycocardial infarction [From date of randomisation until the date of of diagnosis of a myocardial infarction]
Fatal and non-fatal
- Hospitalisations [From date of randomisation until the date of hospitalisation]
Hospitalisation reasons and length of stay
- New onset diabetes [From date of randomisation until the date of diagnosis of diabetes]
New diagnosis of diabetes
- Fatal and Non-fatal Cancer [From date of randomisation until the date of death due to cancer or date of first date of first cancer event]
Fatal and Non-fatal Cancer (excluding non-melanoma skin cancer)
- Cognitive decline [From date of randomisation until the date of a change in the 3Ms resulting in a diagnosis of cognitive decline]
Cognitive decline as assessed using the 3MS excluding depression
- Quality of life measured by the Short Form Health Survey (SF-36) [Assessed annually]
Quality of life (measured by the Short Form Health Survey (SF-36) administered at every second year of follow-up).
- Cost-effectiveness of statin [Up to 60 months]
Cost-effectiveness of statin
- Fatal and Non-fatal Stroke [From date of randomisation until the date of a diagnoses stroke]
Fatal and Non-fatal Stroke can be a) haemorrhagic or b) thromboembolic
- Approved need for permanent residential care [Approved need for residential care as reported by the Aged care assessment team]
ACAS report
- All cause dementia [All cause dementia as assessed by cognitive tests]
All-cause dementia (COWAT, Stroop test, Trail Making Test, HVLT-R, SDMT, ADAS-Cog, Lurian overlapping figures)
- Frailty/Disability [As assesed using the KATZ-ADL]
KATZ-ADL administered every 6 months
Eligibility Criteria
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 or heart failure),
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A history of dementia or a 3MS score <78 on screening,
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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),
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Moderate or severe liver disease (persistent elevations of transaminases of more than 3 times the upper limit of the normal laboratory reference range),
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Serious inter-current illness likely to cause death within the next 5 years such as terminal cancer or obstructive airways disease,
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Current participation in a clinical trial (Note: If yes, this is only an exclusion if other trial involves taking a drug or another intervention)
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Absolute contraindication to statin therapy,
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Current use of statin therapy or other lipid lowering therapy for primary prevention and unwilling to stop therapy,
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tasmania | Hobart | Tasmania | Australia | |
| 2 | Victoria | Melbourne | Victoria | Australia | |
| 3 | South Australia | Adelaide | Western Australia | Australia | |
| 4 | Queensland | Brisbane | Australia | ||
| 5 | New South Wales | Newcastle | Australia | ||
| 6 | Western Australia | Perth | Australia |
Sponsors and Collaborators
- Monash University
- National Health and Medical Research Council, Australia
- National Heart Foundation, Australia
Investigators
- Principal Investigator: Sophia Zoungas, MBBS, FRACP, Monash University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NHMRC 1068146