Aspirin in Reducing Events in the Elderly

Stroke Clinical Trial

— ASPREE  

Official title:

Aspirin in Reducing Events in the Elderly

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01038583
• Other study ID #: HSR#09-3029
• Secondary ID: 3U01AG029824-07S
• Status: Active, not recruiting
• Start date: January 2010
• Est. completion date: April 2024

Study information

• Verified date: April 2021
• Source: Hennepin Healthcare Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 19114
• Est. completion date: April 2024
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Bleeding
• Cancer
• Dementia
• Depression
• Functional Disability
• Heart Disease
• Heart Diseases
• Hemorrhage
• Stroke

Intervention

Drug:
• 100 mg enteric-coated aspirin
100 mg enteric-coated aspirin, taken daily
• Placebo
100 mg enteric-coated placebo

Locations

Country	Name	City	State
Australia	Discipline of General Practice, School of Population Health, University of Adelaide	Adelaide	South Australia
Australia	Bendigo Regional Clinical School	Bendigo	Victoria
Australia	University of Tasmania Rural Clinical School	Burnie	Tasmania
Australia	Clinical Trials Unit, The Canberra Hospital	Garran	Australian Capital Territory
Australia	Geelong Hospital	Geelong	Victoria
Australia	The Menzies Institute for Medical Research, University of Tasmania	Hobart	Tasmania
Australia	University of Tasmania Newnham Campus	Launceston	Tasmania
Australia	Monash Mildura Regional Clinical School	Mildura	Victoria
Australia	Greater Green Triangle University	Mount Gambier	South Australia
Australia	University of Ballarat	Mount Helen	Victoria
Australia	Monash Gippsland Regional Clinical School	Traralgon	Victoria
Australia	The South West Alliance of Rural Health (SWARH)	Warrnambool	Victoria
Australia	Gateway Community Health	Wodonga	Victoria
Australia	Illawarra Health and Medical Research Institute, University of Wollongong	Wollongong	New South Wales
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory/ Atlanta VAMC	Atlanta	Georgia
United States	Morehouse School of Medicine	Atlanta	Georgia
United States	Georgia Health Sciences University	Augusta	Georgia
United States	Mary Bird Perkins Our Lady of the Lake Cancer Center	Baton Rouge	Louisiana
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Rush Alzheimer's Disease Center	Chicago	Illinois
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Wayne State University	Detroit	Michigan
United States	Central Jersey Medical Center	Elizabeth	New Jersey
United States	University of Florida Department of Aging and Geriatrics	Gainesville	Florida
United States	University of TX Medical Branch	Galveston	Texas
United States	Wake Forest University Baptist Medical Center	Greensboro	North Carolina
United States	The Brody School of Medicine at ECU	Greenville	North Carolina
United States	Regional Academic Health Center	Harlingen	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Kansas University Medical Center	Kansas City	Kansas
United States	University of Tennessee Health Science Center	Memphis	Tennessee
United States	Winthrop University Hospital	Mineola	New York
United States	HealthPartners Research Institute	Minneapolis	Minnesota
United States	LSU Health Sciences- New Orleans	New Orleans	Louisiana
United States	Tulane Medical Center	New Orleans	Louisiana
United States	Detroit Clinical Research Center	Novi	Michigan
United States	Palo Alto Medical Foundation Research Institute	Palo Alto	California
United States	Memorial Hospital of Rhode Island	Pawtucket	Rhode Island
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	University of Pittsburgh Health Sciences Research Center	Pittsburgh	Pennsylvania
United States	Phalen Village Clinic	Saint Paul	Minnesota
United States	UT Health Science Center at San Antonio	San Antonio	Texas
United States	LSU Health Sciences- Shreveport	Shreveport	Louisiana
United States	Howard University	Washington	District of Columbia

Sponsors (7)

Lead Sponsor	Collaborator
Hennepin Healthcare Research Institute	Bayer, Berman Center for Outcomes and Clinical Research, Monash University, National Cancer Institute (NCI), National Health and Medical Research Council, Australia, National Institute on Aging (NIA)

Countries where clinical trial is conducted

United States,  Australia, 

References & Publications (2)

ASPREE Investigator Group. Study design of ASPirin in Reducing Events in the Elderly (ASPREE): a randomized, controlled trial. Contemp Clin Trials. 2013 Nov;36(2):555-64. doi: 10.1016/j.cct.2013.09.014. Epub 2013 Oct 7. — View Citation

Barker AL, McNeil JJ, Seeman E, Ward SA, Sanders KM, Khosla S, Cumming RG, Pasco JA, Bohensky MA, Ebeling PR, Woods RL, Lockery JE, Wolfe R, Talevski J; ASPREE Investigator Group. A randomised controlled trial of low-dose aspirin for the prevention of fractures in healthy older people: protocol for the ASPREE-Fracture substudy. Inj Prev. 2016 Aug;22(4):297-301. doi: 10.1136/injuryprev-2015-041655. Epub 2015 May 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is death from any cause or incident, dementia or persistent physical disability.	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	every 6 months
Secondary	All-cause mortality		every 6 months
Secondary	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
Secondary	Fatal and non-fatal cancer, excluding non-melanoma skin cancer		every 6 months
Secondary	Dementia		every 6 months
Secondary	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
Secondary	Physical disability		every 6 months
Secondary	Major hemorrhagic events		every 6 months
Secondary	Depression		Annually

External Links

•   Public ASPREE website