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. Identifier: NCT01038583
Recruitment Status : Active, not recruiting
First Posted : December 24, 2009
Last Update Posted : July 21, 2017
National Health and Medical Research Council, Australia
Monash University
Berman Center for Outcomes and Clinical Research
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation

Brief Summary:

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19000 participants
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
Study Start Date : January 2010
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia
Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: Aspirin
100 mg enteric-coated aspirin
Drug: 100 mg enteric-coated aspirin
100 mg enteric-coated aspirin, taken daily

Placebo Comparator: Placebo
Drug: Placebo
100 mg enteric-coated placebo

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

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: every 6 months ]
  2. 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 ]
  3. Fatal and non-fatal cancer, excluding non-melanoma skin cancer [ Time Frame: every 6 months ]
  4. Dementia [ Time Frame: every 6 months ]
  5. 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 ]
  6. Physical disability [ Time Frame: every 6 months ]
  7. Major hemorrhagic events [ Time Frame: every 6 months ]
  8. Depression [ Time Frame: Annually ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT01038583

  Hide Study Locations
United States, Alabama
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Palo Alto Medical Foundation Research Institute
Palo Alto, California, United States, 94301
United States, District of Columbia
Howard University
Washington, D.C., District of Columbia, United States, 20060
United States, Florida
University of Florida Department of Aging and Geriatrics
Gainesville, Florida, United States, 32611
United States, Georgia
Morehouse School of Medicine
Atlanta, Georgia, United States, 30310
Emory/ Atlanta VAMC
Atlanta, Georgia, United States, 30322
Georgia Health Sciences University
Augusta, Georgia, United States, 30912
United States, Illinois
Rush Alzheimer's Disease Center
Chicago, Illinois, United States, 60612
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66106
United States, Louisiana
Baton Rouge General
Baton Rouge, Louisiana, United States, 70801
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Mary Bird Perkins Our Lady of the Lake Cancer Center
Baton Rouge, Louisiana, United States, 70809
Mary Bird Perkins St. Tammany Parish Hospital
Covington, Louisiana, United States, 70433
Mary Bird Perkins Terrebonne General Hospital
Houma, Louisiana, United States, 70360
LSU Health Sciences- New Orleans
New Orleans, Louisiana, United States, 70112
Tulane Medical Center
New Orleans, Louisiana, United States, 70112
LSU Health Sciences- Shreveport
Shreveport, Louisiana, United States, 71130
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Wayne State University
Detroit, Michigan, United States, 48201
Henry Ford Health System
Detroit, Michigan, United States, 48202
Detroit Clinical Research Center
Novi, Michigan, United States, 48377
United States, Minnesota
Health Partners Research Foundation
Minneapolis, Minnesota, United States, 55425
Phalen Village Clinic
Saint Paul, Minnesota, United States, 55106
United States, New Jersey
Central Jersey Medical Center
Elizabeth, New Jersey, United States, 07202
New Jersey Medical College
Newark, New Jersey, United States, 07103
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
United States, North Carolina
Wake Forest University Baptist Medical Center
Greensboro, North Carolina, United States, 27408
The Brody School of Medicine at ECU
Greenville, North Carolina, United States, 27834
United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
University of Pittsburgh Health Sciences Research Center
Pittsburgh, Pennsylvania, United States, 15260
United States, Rhode Island
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States, 02860
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38105
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
University of TX Medical Branch
Galveston, Texas, United States, 77555
Regional Academic Health Center
Harlingen, Texas, United States, 78550
UT Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Australia, Australian Capital Territory
Clinical Trials Unit, The Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Illawarra Health and Medical Research Institute, University of Wollongong
Wollongong, New South Wales, Australia, 2522
Australia, South Australia
Discipline of General Practice, School of Population Health, University of Adelaide
Adelaide, SA 5005, South Australia, Australia, 5005
Greater Green Triangle University
Mount Gambier, South Australia, Australia, 5290
Australia, Tasmania
University of Tasmania Rural Clinical School
Burnie, Tasmania, Australia, 7320
The Menzies Institute for Medical Research, University of Tasmania
Hobart, Tasmania, Australia, 7000
University of Tasmania Newnham Campus
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Bendigo Regional Clinical School
Bendigo, Victoria, Australia, 3550
Geelong Hospital
Geelong, Victoria, Australia, 3220
Monash Mildura Regional Clinical School
Mildura West, Victoria, Australia, 3500
University of Ballarat
Mount Helen, Victoria, Australia, 3350
Monash Gippsland Regional Clinical School
Traralgon, Victoria, Australia, 3844
The South West Alliance of Rural Health (SWARH)
Warrnambool, Victoria, Australia, 3280
Gateway Community Health
Wodonga, Victoria, Australia, 3690
Sponsors and Collaborators
Minneapolis Medical Research Foundation
National Health and Medical Research Council, Australia
Monash University
Berman Center for Outcomes and Clinical Research
National Institute on Aging (NIA)
Principal Investigator: Anne Murray, MD, MSc Berman Center for Outcomes and Clinical Research
Principal Investigator: John McNeil, MBBS, PHD Monash University

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

Keywords provided by Minneapolis Medical Research Foundation:
Over 65 years old
Aspirin in Reducing Events in the Elderly
Functional disability
Heart Disease/ Stroke

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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