Aspirin in Reducing Events in the Elderly (ASPREE)

This study is ongoing, but not recruiting participants.
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: December 8, 2014
Last verified: December 2014
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]
  • Depression [ Time Frame: Annually ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038583

  Hide Study Locations
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, District of Columbia, United States, 20060
United States, Florida
University of Florida Department of Aging and Geriatrics
Gainsville, Florida, United States, 32611
United States, Georgia
Emory/ Atlanta VAMC
Atlanta, Georgia, United States, 30322
Morehouse School of Medicine
Atlanta, Georgia, United States, 30310
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
Mary Bird Perkins Our Lady of the Lake Cancer Center
Baton Rouge, Louisiana, United States, 70809
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Mary Bird Perkins St. Tammany Parish Hospital
Covington, Louisiana, United States, 70433
Mary Bird Perkins Terrebonne General Hospital
Houma, Louisiana, United States, 70360
Tulane Medical Center
New Orleans, Louisiana, United States, 70112
LSU Health Sciences- New Orleans
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
Henry Ford Health System
Detroit, Michigan, United States, 48202
Wayne State University
Detroit, Michigan, United States, 48201
Detroit Clinical Research Center
Novi, Michigan, United States, 48377
United States, Minnesota
Health Partners Research Foundation
Minneapolis, Minnesota, United States, 55425
Phalen Village Clinic
St. 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
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
Winthrop University Hospital
Mineola, New York, United States, 11501
Queens Cancer Medical Center
Queens, New York, United States, 11432
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
Meharry Medical College
Nashville, Tennessee, United States, 57208
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
Sponsors and Collaborators
Minneapolis Medical Research Foundation
National Health and Medical Research Council, Australia
Bayer
Monash University
Berman Center for Outcomes and Clinical Research
Investigators
Principal Investigator: Richard Grimm, MD, PHD Berman Center for Outcomes and Clinical Research
Principal Investigator: John McNeil, MBBS, PHD Monash University
  More Information

Additional Information:
No publications provided by Minneapolis Medical Research Foundation

Additional 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
Study First Received: December 21, 2009
Last Updated: December 8, 2014
Health Authority: United States: Institutional Review Board

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
Cardiovascular Diseases
Aspirin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2015