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

Healthy Clinical Trial

— STAREE  

Official title:

A Study of STAtins for Reducing Events in the Elderly (STAREE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02099123
• Other study ID #: NHMRC 1068146
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 2015
• Est. completion date: December 2025

Study information

• Verified date: March 2023
• Source: Monash University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9971
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disability Free Survival
• Elderly
• Healthy
• Independent Living

Intervention

Drug:
• Atorvastatin
Atorvastatin 20 mg tablet
• Placebo (for Atorvastatin)
Inactive pill manufactured to mimic Atorvastatin 20 mg tablet

Locations

Country	Name	City	State
Australia	South Australia	Adelaide	Western Australia
Australia	Queensland	Brisbane
Australia	Tasmania	Hobart	Tasmania
Australia	Victoria	Melbourne	Victoria
Australia	New South Wales	Newcastle
Australia	Western Australia	Perth

Sponsors (3)

Lead Sponsor	Collaborator
Monash University	National Health and Medical Research Council, Australia, National Heart Foundation, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	New onset diabetes	New diagnosis of diabetes	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.
Primary	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 from randomisation to a primary endpoint or censoring at the end of study follow-up which is anticipated to be an average 6 years.
Primary	Major cardiovascular events	Defined as the first occurrence of a non-fatal myocardial infarction, non-fatal stroke or cardiovascular death	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	Cardiovascular death	Fatal cardiovascular events	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.
Secondary	Fatal and Non-fatal Mycocardial infarction	Fatal and non-fatal	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.
Secondary	Hospitalisations	Hospitalisation reasons and length of stay	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.
Secondary	Fatal and Non-fatal Cancer	Fatal and Non-fatal Cancer (excluding non-melanoma skin cancer)	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.
Secondary	Other cognitive impairment	Cognitive decline as assessed using cognitive tests excluding depression	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.
Secondary	Quality of life measured by the Short Form Health Survey (SF-36)	Quality of life (measured by the Short Form Health Survey (SF-36) administered at every second year of follow-up).	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.
Secondary	Cost-effectiveness of statin	Cost-effectiveness of statin	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.
Secondary	Fatal and Non-fatal Stroke	Fatal and Non-fatal Stroke can be a) haemorrhagic or b) thromboembolic	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.
Secondary	Approved need for permanent residential care	ACAS report	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.
Secondary	Dementia	All-cause dementia (COWAT, Stroop test, Trail Making Test, HVLT-R, SDMT, ADAS-Cog, Lurian overlapping figures) or external diagnosis	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.
Secondary	Persistent physical disability	KATZ-ADL administered every 6 months or external diagnosis	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.
Secondary	All cause death	All cause death	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.
Secondary	Heart failure	Heart failure	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.
Secondary	Atrial fibrillation	Atrial fibrillation	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.
Secondary	Revascularisation procedure	Revascularisation procedure	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.