NCT02099123

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

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 9,971 (actual)
• Sponsor: Monash University · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Independent Living
• Disability Free Survival
• Elderly
• Healthy

Interventions

Type	Name	Description
DRUG	Atorvastatin	Atorvastatin 20 mg tablet
DRUG	Placebo (for Atorvastatin)	Inactive pill manufactured to mimic Atorvastatin 20 mg tablet

Timeline

• Start date: 2015-07-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2014-03-28
• Last updated: 2024-11-21

Locations

6 sites across 1 country: Australia