Clinical trial NCT02099123: A Clinical Trial of STAtin Therapy for Reducing Events in the Elderly (STAREE)
Official title: A Study of STAtins for Reducing Events in the Elderly (STAREE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Independent Living
Disability Free Survival
Elderly
Healthy
Keywords: Survival
Functional Disability
Cardiovascular Disease
Diabetes
Dementia
Cancer
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
name: National Heart Foundation, Australia
First posted: 2014-03-28
Enrollment: 9971
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The STAREE study will examine whether treatment with statin (atorvastatin 40mg) compared with placebo will prolong disability free survival and reduce major cardiovascular events amongst healthy elderly people (≥70 years).

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.

Eligibility 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.

Primary outcomes:
measure: Disability free survival - death or development of dementia or development of persistent physical disability
timeFrame: Time from randomisation to a primary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
measure: Major cardiovascular events
timeFrame: Time from randomisation to a primary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Secondary outcomes:
measure: A composite of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke
timeFrame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
measure: Cardiovascular death
timeFrame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
measure: Fatal and Non-fatal Mycocardial infarction
timeFrame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
measure: Hospitalisations
timeFrame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
measure: Fatal and Non-fatal Cancer
timeFrame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
measure: Other cognitive impairment
timeFrame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
measure: Quality of life measured by the Short Form Health Survey (SF-36)
timeFrame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
measure: Cost-effectiveness of statin
timeFrame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
measure: Fatal and Non-fatal Stroke
timeFrame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
measure: Approved need for permanent residential care
timeFrame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
measure: Dementia
timeFrame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
measure: Persistent physical disability
timeFrame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
measure: All cause death
timeFrame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
measure: Heart failure
timeFrame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
measure: Atrial fibrillation
timeFrame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
measure: Revascularisation procedure
timeFrame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Other outcomes:
measure: New onset diabetes
timeFrame: Time from randomisation to a secondary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Locations:
city: Hobart
country: Australia
facility: Tasmania
state: Tasmania
city: Melbourne
country: Australia
facility: Victoria
state: Victoria
city: Adelaide
country: Australia
facility: South Australia
state: Western Australia
city: Brisbane
country: Australia
facility: Queensland
city: Newcastle
country: Australia
facility: New South Wales
city: Perth
country: Australia
facility: Western Australia
Study officials:
affiliation: Monash University
name: Sophia Zoungas, MBBS, FRACP
role: PRINCIPAL_INVESTIGATOR
References: