A Clinical Trial of STAtin Therapy for Reducing Events in the Elderly (STAREE) (STAREE)
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|ClinicalTrials.gov Identifier: NCT02099123|
Recruitment Status : Enrolling by invitation
First Posted : March 28, 2014
Last Update Posted : August 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Independent Living Disability Free Survival Elderly Healthy||Drug: Atorvastatin Drug: Placebo (for Atorvastatin)||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Study of STAtins for Reducing Events in the Elderly (STAREE)|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
40 mg atorvastatin (2 x 20 mg atorvastatin), taken orally once daily
Atorvastatin 20 mg tablet
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
- (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 Frame: 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.
- Cardiovascular death [ Time Frame: From date of randomisation until the date of a death to a cardiovascular cause ]Fatal cardiovascular events
- Mycocardial infarction [ Time Frame: From date of randomisation until the date of of diagnosis of a myocardial infarction ]
- Hospitalisations [ Time Frame: From date of randomisation until the date of hospitalisation ]Hospitalisation reasons and length of stay
- New onset diabetes [ Time Frame: From date of randomisation until the date of diagnosis of diabetes ]New diagnosis of diabetes
- Fatal and Non-fatal Cancer [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 60 months ]Cost-effectiveness of statin
- Stroke [ Time Frame: From date of randomisation until the date of a diagnoses stroke ]Stroke can be a) haemorrhagic or b) thromboembolic
- Approved need for permanent residential care [ Time Frame: Approved need for residential care as reported by the Aged care assessment team ]ACAS report
- All cause dementia [ Time Frame: 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 [ Time Frame: As assesed using the KATZ-ADL ]KATZ-ADL administered every 6 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099123
|Hobart, Tasmania, Australia|
|Melbourne, Victoria, Australia|
|New South Wales|
|Principal Investigator:||Sophia Zoungas, MBBS, FRACP||Monash University|