A Clinical Trial of STAtin Therapy for Reducing Events in the Elderly (STAREE) (STAREE)

Study Description

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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
Independent Living; Disability Free Survival; Elderly; Healthy	Drug: Atorvastatin; Drug: Placebo (for Atorvastatin)	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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	18000 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
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

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Atorvastatin; 40 mg atorvastatin (2 x 20 mg atorvastatin), taken orally once daily	Drug: Atorvastatin; 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

Outcome Measures

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Primary Outcome Measures :

1. (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.

Secondary Outcome Measures :

1. Cardiovascular death [ Time Frame: From date of randomisation until the date of a death to a cardiovascular cause ]
   Fatal cardiovascular events
2. Mycocardial infarction [ Time Frame: From date of randomisation until the date of of diagnosis of a myocardial infarction ]
3. Hospitalisations [ Time Frame: From date of randomisation until the date of hospitalisation ]
   Hospitalisation reasons and length of stay
4. New onset diabetes [ Time Frame: From date of randomisation until the date of diagnosis of diabetes ]
   New diagnosis of diabetes
5. 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)
6. 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
7. 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).
8. Cost-effectiveness of statin [ Time Frame: Up to 60 months ]
   Cost-effectiveness of statin
9. Stroke [ Time Frame: From date of randomisation until the date of a diagnoses stroke ]
   Stroke can be a) haemorrhagic or b) thromboembolic
10. Approved need for permanent residential care [ Time Frame: Approved need for residential care as reported by the Aged care assessment team ]
    ACAS report
11. 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)
12. Frailty/Disability [ Time Frame: As assesed using the KATZ-ADL ]
    KATZ-ADL administered every 6 months

Eligibility Criteria

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Ages Eligible for Study:	70 Years and older (Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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),

• 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 (Note: If yes, this is only an exclusion if other trial involves taking a drug or another intervention)
• 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.

Contacts and Locations

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Locations

Australia, Tasmania
Tasmania
Hobart, Tasmania, Australia
Australia, Victoria
Victoria
Melbourne, Victoria, Australia
Australia
Queensland
Brisbane, Australia
New South Wales
Newcastle, Australia
Western Australia
Perth, Australia

Sponsors and Collaborators

Monash University

National Health and Medical Research Council, Australia

Investigators

Principal Investigator:	Sophia Zoungas, MBBS, FRACP	Monash University

More Information

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Responsible Party:	Sophia Zoungas, Associate Professor Sophia Zoungas, Monash University
ClinicalTrials.gov Identifier:	NCT02099123 History of Changes
Other Study ID Numbers:	NHMRC 1068146
First Posted:	March 28, 2014
Last Update Posted:	August 22, 2017
Last Verified:	August 2017

Keywords provided by Sophia Zoungas, Monash University:

Survival; Functional Disability; Cardiovascular Disease	Diabetes; Dementia; Cancer

Additional relevant MeSH terms:

Atorvastatin Calcium; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites	Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors