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Aspirin in Reducing Events in the Elderly (ASPREE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01038583
Recruitment Status : Active, not recruiting
First Posted : December 24, 2009
Last Update Posted : May 30, 2019
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Bayer
Monash University
Berman Center for Outcomes and Clinical Research
National Institute on Aging (NIA)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Hennepin Healthcare Research Institute.

Tracking Information
First Submitted Date December 21, 2009
First Posted Date December 24, 2009
Last Update Posted Date May 30, 2019
Actual Study Start Date January 2010
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2018)
The primary endpoint is death from any cause or incident, dementia or persistent physical disability. [ Time Frame: 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
Original Primary Outcome Measures
 (submitted: December 23, 2009)
The primary endpoint is death from any cause or incident, dementia or persistent physical disability. [ Time Frame: every 3-6 months ]
Change History Complete list of historical versions of study NCT01038583 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 8, 2014)
  • All-cause mortality [ Time Frame: 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 [ Time Frame: every 6 months ]
  • Fatal and non-fatal cancer, excluding non-melanoma skin cancer [ Time Frame: every 6 months ]
  • Dementia [ Time Frame: 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) [ Time Frame: every 6 months ]
  • Physical disability [ Time Frame: every 6 months ]
  • Major hemorrhagic events [ Time Frame: every 6 months ]
  • Depression [ Time Frame: Annually ]
Original Secondary Outcome Measures
 (submitted: December 23, 2009)
  • All-cause mortality [ Time Frame: every 3-6 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 [ Time Frame: every 3-6 months ]
  • Fatal and non-fatal cancer, excluding non-melanoma skin cancer [ Time Frame: every 3-6 months ]
  • Dementia [ Time Frame: every 3-6 months ]
  • Mild Cognitive Impairment (MCI; assessed using the Modified Mini-Mental State Examination or 3MS 70 and other cognitive function measures - see below) [ Time Frame: every 3-6 months ]
  • Physical disability [ Time Frame: every 3-6 months ]
  • Major hemorrhagic events [ Time Frame: every 3-6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Aspirin in Reducing Events in the Elderly
Official Title Aspirin in Reducing Events in the Elderly
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population

Men and women recruited from the US and Australia.

  • African American and Hispanic persons age 65 or older in the US
  • 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
Condition
  • Functional Disability
  • Dementia
  • Heart Disease
  • Stroke
  • Cancer
  • Bleeding
  • Depression
Intervention
  • Drug: 100 mg enteric-coated aspirin
    100 mg enteric-coated aspirin, taken daily
  • Drug: Placebo
    100 mg enteric-coated placebo
Study Groups/Cohorts
  • Aspirin
    100 mg enteric-coated aspirin
    Intervention: Drug: 100 mg enteric-coated aspirin
  • Placebo
    Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: December 17, 2018)
19114
Original Estimated Enrollment
 (submitted: December 23, 2009)
19000
Estimated Study Completion Date April 2024
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01038583
Other Study ID Numbers HSR#09-3029
3U01AG029824-07S2 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Working with ASPREE - for Data Access requests Monitored secure portal - development underway
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: 2019
Access Criteria: Will be defined in the Working with ASPREE document
Responsible Party Hennepin Healthcare Research Institute.
Study Sponsor Hennepin Healthcare Research Institute.
Collaborators
  • National Health and Medical Research Council, Australia
  • Bayer
  • Monash University
  • Berman Center for Outcomes and Clinical Research
  • National Institute on Aging (NIA)
  • National Cancer Institute (NCI)
Investigators
Principal Investigator: Anne Murray, MD, MSc Berman Center for Outcomes and Clinical Research
Principal Investigator: John McNeil, MBBS, PHD Monash University
PRS Account Hennepin Healthcare Research Institute.
Verification Date May 2019