Aspirin in Reducing Events in the Elderly
- Conditions
- CancerFunctional DisabilityDementiaHeart DiseaseStrokeBleedingDepression
- Interventions
- Drug: Placebo
- Registration Number
- NCT01038583
- Lead Sponsor
- Hennepin Healthcare Research Institute
- Brief Summary
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.
- Detailed Description
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:
1. 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.
2. 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.
3. 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 19114
- 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
- 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
- Anemia
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo Aspirin 100 mg enteric-coated aspirin 100 mg enteric-coated aspirin
- Primary Outcome Measures
Name Time Method The primary endpoint is death from any cause or incident, dementia or persistent physical disability. 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (47)
Detroit Clinical Research Center
🇺🇸Novi, Michigan, United States
Wake Forest University Baptist Medical Center
🇺🇸Greensboro, North Carolina, United States
University of TX Medical Branch
🇺🇸Galveston, Texas, United States
University of Pittsburgh Health Sciences Research Center
🇺🇸Pittsburgh, Pennsylvania, United States
LSU Health Sciences- Shreveport
🇺🇸Shreveport, Louisiana, United States
Phalen Village Clinic
🇺🇸Saint Paul, Minnesota, United States
Emory/ Atlanta VAMC
🇺🇸Atlanta, Georgia, United States
Mary Bird Perkins Our Lady of the Lake Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
Georgia Health Sciences University
🇺🇸Augusta, Georgia, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Central Jersey Medical Center
🇺🇸Elizabeth, New Jersey, United States
Howard University
🇺🇸Washington, District of Columbia, United States
Morehouse School of Medicine
🇺🇸Atlanta, Georgia, United States
University of Florida Department of Aging and Geriatrics
🇺🇸Gainesville, Florida, United States
LSU Health Sciences- New Orleans
🇺🇸New Orleans, Louisiana, United States
Regional Academic Health Center
🇺🇸Harlingen, Texas, United States
The Brody School of Medicine at ECU
🇺🇸Greenville, North Carolina, United States
Tulane Medical Center
🇺🇸New Orleans, Louisiana, United States
University of Tennessee Health Science Center
🇺🇸Memphis, Tennessee, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Discipline of General Practice, School of Population Health, University of Adelaide
🇦🇺Adelaide, South Australia, Australia
Monash Gippsland Regional Clinical School
🇦🇺Traralgon, Victoria, Australia
Clinical Trials Unit, The Canberra Hospital
🇦🇺Garran, Australian Capital Territory, Australia
Geelong Hospital
🇦🇺Geelong, Victoria, Australia
Greater Green Triangle University
🇦🇺Mount Gambier, South Australia, Australia
University of Tasmania Rural Clinical School
🇦🇺Burnie, Tasmania, Australia
Rush Alzheimer's Disease Center
🇺🇸Chicago, Illinois, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
UT Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
HealthPartners Research Institute
🇺🇸Minneapolis, Minnesota, United States
Palo Alto Medical Foundation Research Institute
🇺🇸Palo Alto, California, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Illawarra Health and Medical Research Institute, University of Wollongong
🇦🇺Wollongong, New South Wales, Australia
University of Tasmania Newnham Campus
🇦🇺Launceston, Tasmania, Australia
The Menzies Institute for Medical Research, University of Tasmania
🇦🇺Hobart, Tasmania, Australia
Bendigo Regional Clinical School
🇦🇺Bendigo, Victoria, Australia
Monash Mildura Regional Clinical School
🇦🇺Mildura, Victoria, Australia
Gateway Community Health
🇦🇺Wodonga, Victoria, Australia
University of Ballarat
🇦🇺Mount Helen, Victoria, Australia
The South West Alliance of Rural Health (SWARH)
🇦🇺Warrnambool, Victoria, Australia
Memorial Hospital of Rhode Island
🇺🇸Pawtucket, Rhode Island, United States