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Aspirin in Reducing Events in the Elderly (ASPREE)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01038583
First Posted: December 24, 2009
Last Update Posted: July 21, 2017
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.
Collaborators:
National Health and Medical Research Council, Australia
Bayer
Monash University
Berman Center for Outcomes and Clinical Research
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation
  Purpose

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.


Condition Intervention Phase
Functional Disability Dementia Heart Disease Stroke Cancer Bleeding Depression Drug: 100 mg enteric-coated aspirin Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Aspirin in Reducing Events in the Elderly

Resource links provided by NLM:


Further study details as provided by Minneapolis Medical Research Foundation:

Primary Outcome Measures:
  • The primary endpoint is death from any cause or incident, dementia or persistent physical disability. [ Time Frame: every 6 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 19000
Study Start Date: January 2010
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aspirin
100 mg enteric-coated aspirin
Drug: 100 mg enteric-coated aspirin
100 mg enteric-coated aspirin, taken daily
Placebo Comparator: Placebo
Placebo
Drug: Placebo
100 mg enteric-coated placebo

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038583


  Show 51 Study Locations
Sponsors and Collaborators
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)
Investigators
Principal Investigator: Anne Murray, MD, MSc Berman Center for Outcomes and Clinical Research
Principal Investigator: John McNeil, MBBS, PHD Monash University
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT01038583     History of Changes
Other Study ID Numbers: HSR#09-3029
3U01AG029824-02S1 ( U.S. NIH Grant/Contract )
First Submitted: December 21, 2009
First Posted: December 24, 2009
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by Minneapolis Medical Research Foundation:
Aspirin
Prevention
Healthy
Over 65 years old
ASPREE
Aspirin in Reducing Events in the Elderly
Australia
Functional disability
Dementia
Heart Disease/ Stroke
Cancer
Bleeding

Additional relevant MeSH terms:
Heart Diseases
Dementia
Hemorrhage
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Pathologic Processes
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics