Aspirin in Reducing Events in the Elderly (ASPREE)

This study is currently recruiting participants.
Verified October 2013 by Minneapolis Medical Research Foundation
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Bayer
Monash University
Berman Center for Outcomes and Clinical Research
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT01038583
First received: December 21, 2009
Last updated: October 18, 2013
Last verified: October 2013

December 21, 2009
October 18, 2013
January 2010
August 2016   (final data collection date for primary outcome measure)
The primary endpoint is death from any cause or incident, dementia or persistent physical disability. [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]
The primary endpoint is death from any cause or incident, dementia or persistent physical disability. [ Time Frame: every 3-6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01038583 on ClinicalTrials.gov Archive Site
  • All-cause mortality [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Fatal and non-fatal cancer, excluding non-melanoma skin cancer [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]
  • Dementia [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Physical disability [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]
  • Major hemorrhagic events [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]
  • All-cause mortality [ Time Frame: every 3-6 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Fatal and non-fatal cancer, excluding non-melanoma skin cancer [ Time Frame: every 3-6 months ] [ Designated as safety issue: Yes ]
  • Dementia [ Time Frame: every 3-6 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Physical disability [ Time Frame: every 3-6 months ] [ Designated as safety issue: Yes ]
  • Major hemorrhagic events [ Time Frame: every 3-6 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Aspirin in Reducing Events in the Elderly
Aspirin in Reducing Events in the Elderly

The ASPREE study will examine whether the potential benefits of low dose aspirin (particularly preventing heart disease, stroke, certain cancers and dementia) outweigh the risks (particularly bleeding) in people over age 65.

ASPREE will determine whether taking a daily low-dose aspirin will extend the length of a disability-free life in healthy participants aged 65 years and above.

Low dose aspirin therapy has been shown to reduce the risk of vascular events, largely in middle-aged people. There is also some evidence of its potential to reduce the rate of intellectual decline and certain types cancers in older participants. However, part of the benefit of aspirin may be offset by adverse effects, such as those related to its potential to cause bleeding.

The balance of risks and benefits of low dose aspirin has not been established in older persons. Previous studies on the effects of aspirin in primary prevention have mainly focused on cardiovascular outcomes. In the elderly, these alone may not be the most appropriate measure of benefit associated with aspirin treatment. Prolonging a life free of functional disability in a healthy aging population would be the most desirable benefit of aspirin as a preventative medicine.

ASPREE will determine whether taking a daily low-dose aspirin will extend the length of a disability-free life in healthy participants aged 65 years and above.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Functional Disability
  • Dementia
  • Heart Disease
  • Stroke
  • Cancer
  • Bleeding
  • Drug: 100 mg enteric-coated aspirin
    100 mg enteric-coated aspirin, taken daily
  • Drug: Placebo
    100 mg enteric-coated placebo
  • Active Comparator: Aspirin
    100 mg enteric-coated aspirin
    Intervention: Drug: 100 mg enteric-coated aspirin
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
19000
August 2016
August 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women
  • African American and Hispanic persons age 65 or older
  • Any person from another ethnic minority group age 70 or older
  • Willing and able to provide informed consent, and willing to accept the study requirements

[ASPREE has completed enrollment of Caucasian participants in the US.]

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
Both
65 Years and older
Yes
Contact: Nathan J Tessum 612-341-7907 ntessum@bermancenter.org
Contact: Brenda Kirpach 612-341-7922 bkirpach@bermancenter.org
United States
 
NCT01038583
1U01AG029824-01A2
Yes
Minneapolis Medical Research Foundation
Minneapolis Medical Research Foundation
  • National Health and Medical Research Council, Australia
  • Bayer
  • Monash University
  • Berman Center for Outcomes and Clinical Research
  • National Institute on Aging (NIA)
Principal Investigator: Richard Grimm, MD, PHD Berman Center for Outcomes and Clinical Research
Principal Investigator: John McNeil, MD Monash University
Minneapolis Medical Research Foundation
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP