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

Phase 4Active Not RecruitingNCT02099123

Monash University9,971 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

9,971

Conditions

Independent Living Disability Free Survival Elderly Healthy

Interventions

AtorvastatinDRUG

Atorvastatin 20 mg tablet

Placebo (for Atorvastatin)DRUG

Inactive pill manufactured to mimic Atorvastatin 20 mg tablet

Eligibility

Sex: ALLMin age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (6)

Tasmania

Hobart, Tasmania, Australia

Victoria

Melbourne, Victoria, Australia

South Australia

Adelaide, Western Australia, Australia

Queensland

Brisbane, Australia

New South Wales

Outcomes

Primary Outcomes

Disability free survival - death or development of dementia or development of persistent physical disability

Defined as survival free of dementia or persistent physical disability (as derived from the endpoints of all-cause mortality, dementia and physical disability)

Time frame: 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.

Major cardiovascular events

Defined as the first occurrence of a cardiovascular death or a non-fatal myocardial infarction or stroke or coronary revascularisation

Time frame: 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

A composite of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke

Time frame: 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.

Cardiovascular death

Fatal cardiovascular events

Time frame: 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.

Fatal and Non-fatal Mycocardial infarction

Fatal and non-fatal

Time frame: 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.

Hospitalisations

Hospitalisation reasons and length of stay

Data from ClinicalTrials.gov

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