A Study of STAtins for Reducing Events in the Elderly (STAREE)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 9,971
- 试验地点
- 6
- 主要终点
- Disability free survival - death or development of dementia or development of persistent physical disability
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Atorvastatin
40 mg atorvastatin (2 x 20 mg atorvastatin), taken orally once daily
干预措施: Atorvastatin (Drug)
Placebo
Placebo (2 x 20 mg placebo) taken orally once daily
干预措施: Placebo (for Atorvastatin) (Drug)
结局指标
主要结局
Disability free survival - death or development of dementia or development of persistent physical disability
时间窗: 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.
Defined as survival free of dementia or persistent physical disability (as derived from the endpoints of all-cause mortality, dementia and physical disability)
Major cardiovascular events
时间窗: 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.
Defined as the first occurrence of a cardiovascular death or a non-fatal myocardial infarction or stroke or coronary revascularisation
次要结局
- A composite of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke(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(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(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(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 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.)
- Other cognitive impairment(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.)
- Quality of life measured by the Short Form Health Survey (SF-36)(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.)
- 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.)
- Fatal and Non-fatal Stroke(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.)
- Approved need for permanent residential care(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.)
- Dementia(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.)
- Persistent physical disability(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.)
- 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.)
- 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.)
- 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.)
- 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.)
研究者
Sophia Zoungas
Professor Sophia Zoungas
Monash University