Aspirin in Reducing Events in the Elderly
试验速览
- 阶段
- 不适用
- 入组人数
- 19,114
- 试验地点
- 47
- 主要终点
- The primary endpoint is death from any cause or incident, dementia or persistent physical disability.
研究概览
简要总结
ASPREE-XT is a post-treatment, longitudinal observational follow-up study of ASPREE participants [ASPREE Investigator Group, 2013; www.aspree.org; McNeil et al 2017]. Although the ASPREE trial medication was ceased, the study activity was not stopped and ASPREE participants are continuing with scheduled visits and phone calls. An observational follow-up phase (ASPREE-XT), began in January, 2018. This will enable the monitoring of possible delayed effects of aspirin treatment, primarily on cancer incidence, metastases and mortality. In addition to monitoring the incidence of malignancy within the ASPREE cohort, the opportunity will be taken to observe any other residual effects of aspirin on the endpoints being monitored in the cohort. Continuity of contact with study participants is the key to retention of the cohort for any ongoing or future studies.
详细描述
ASPREE BACKGROUND:
ASPREE (ASPirin in Reducing Events in the Elderly) is a joint US/Australian research project aiming to determine whether low-dose aspirin increases healthy life-span, defined as survival free of dementia and disability. ASPREE began in 2010 and completed recruitment in 2014. It is a randomized, double-blind, placebo-controlled, primary prevention trial of daily 100 mg of aspirin in a population of healthy older people in the United States (US) and Australia with a period of treatment averaging 4.5 years. ASPREE's primary outcome is length of survival free of dementia and disability and has secondary outcomes encompassing the major health issues related to aging. The trial involving 19,114 persons aged 70 and above (65 years and above for US minorities) is distinctive for its large size, methodological rigor and high participant retention rate in both countries.
ASPREE UNIQUE ASPECTS:
- It is the first large scale trial to incorporate dementia-free and disability-free survival as a primary outcome. This is now recognized as an appropriate goal of treatment in a primary prevention population of this age group. Within a clinical trial context disability-free survival incorporates an estimate of the overall benefits and risks of aspirin in a single outcome measure.
- It is one of the first primary prevention trials of aspirin to include cancer incidence, metastases or mortality as a pre-specified endpoint. Recent meta-analyses [Rothwell et al 2010, 2011, 2012] suggests that aspirin has a significant chemopreventive effect becoming evident after a period of 4+ years of aspirin treatment, but questions remain about the magnitude of benefit, and whether it applies to treatment of all cancers and to older people.
- It will provide information about the impact of aspirin on a range of other conditions (e.g, dementia, CVD, stroke, depression, bleeding) where aspirin has been claimed to have benefit (or risks).
The intervention phase of the trial ended in June 2017 after the NIA determined that it was highly unlikely that aspirin would show a benefit on the overall primary outcome within the planned 5-year time frame. The study is now entering a data cleaning and analysis phase and it is anticipated that the primary results were published in September 2018.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women
- •African American and Hispanic persons age 65 or older
- •Any person from another ethnic minority group and Caucasian persons age 70 or older
- •Willing and able to provide informed consent, and willing to accept the study requirements
排除标准
- •A history of a diagnosed cardiovascular event
- •A serious intercurrent illness likely to cause death within the next 5 years, such as terminal cancer or obstructive airways disease
- •A current or recurrent condition with a high risk of major bleeding, ex: cerebral aneurysm
- •Absolute contraindication or allergy to aspirin
- •Current participation in a clinical trial
- •Current continuous use of aspirin or other anti-platelet drug or anticoagulant for secondary prevention. People with previous use of aspirin for primary prevention may enter the trial, provided they agree to cease existing use of aspirin and understand that they may be subsequently randomly allocated to low dose aspirin or placebo.
- •A systolic blood pressure ≥180 mmHg and / or a diastolic blood pressure ≥105 mmHg
- •A history of dementia
- •Severe difficulty or an inability to perform any one of the 6 Katz ADLs
- •Non-compliance to taking pill
研究组 & 干预措施
Aspirin
100 mg enteric-coated aspirin
干预措施: 100 mg enteric-coated aspirin (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The primary endpoint is death from any cause or incident, dementia or persistent physical disability.
时间窗: every 6 months
Dementia will be diagnosed based on DSM-IV criteria. Significant physical disability will be defined as a confirmed, and persisting for at least 6 months, self-report of 'a lot of difficulty', or 'inability to perform independently' any one of the 6 Katz basic Activities of Daily Living (ADLs).75
次要结局
- All-cause mortality(every 6 months)
- Fatal and non fatal cardiovascular events including a) coronary heart disease death, b) non-fatal MI, c) fatal and non-fatal stroke and d) any hospitalization for heart failure(every 6 months)
- Fatal and non-fatal cancer, excluding non-melanoma skin cancer(every 6 months)
- Dementia(every 6 months)
- Mild Cognitive Impairment (MCI; assessed using the Modified Mini-Mental State Examination or 3MS 70 and other cognitive function measures - see below)(every 6 months)
- Physical disability(every 6 months)
- Major hemorrhagic events(every 6 months)
- Depression(Annually)