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Aspirin in Reducing Events in the Elderly


Phase 4
65 Years
N/A
Open (Enrolling)
Both
Functional Disability, Dementia, Heart Disease, Stroke, Cancer, Bleeding

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Trial Information

Aspirin in Reducing Events in the Elderly


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

The primary endpoint is death from any cause or incident, dementia or persistent physical disability.

Outcome Time Frame:

every 3-6 months

Safety Issue:

Yes

Principal Investigator

Richard Grimm, MD, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Berman Center for Outcomes and Clinical Research

Authority:

United States: Institutional Review Board

Study ID:

1U01AG029824-01A2

NCT ID:

NCT01038583

Start Date:

January 2010

Completion Date:

August 2016

Related Keywords:

  • Functional Disability
  • Dementia
  • Heart Disease
  • Stroke
  • Cancer
  • Bleeding
  • Aspirin
  • Prevention
  • Healthy
  • Over 65 years old
  • ASPREE
  • Aspirin in Reducing Events in the Elderly
  • Australia
  • Functional disability
  • Dementia
  • Heart Disease/ Stroke
  • Cancer
  • Bleeding
  • Dementia
  • Heart Diseases
  • Hemorrhage
  • Stroke

Name

Location
The University of Alabama at Birmingham Birmingham, Alabama  35294
University of Iowa Iowa City, Iowa  52242
University of Michigan Ann Arbor, Michigan  48109-0624
Winthrop University Hospital Mineola, New York  11501
University of Texas Southwestern Medical Center at Dallas Dallas, Texas  75235-8897
Howard University Washington, District of Columbia  20059
Memorial Hospital of Rhode Island Pawtucket, Rhode Island  02860
Henry Ford Health System Detroit, Michigan  48202
Wayne State University Detroit, Michigan  48202
Albert Einstein Medical Center Philadelphia, Pennsylvania  19141
Kansas University Medical Center Kansas City,, Kansas  66160-7390
Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157
UT Health Science Center at San Antonio San Antonio, Texas  78258
Morehouse School of Medicine Atlanta, Georgia  30310-1495
Pennington Biomedical Research Center Baton Rouge, Louisiana  70808
Palo Alto Medical Foundation Research Institute Palo Alto, California  94301
Health Partners Research Foundation Minneapolis, Minnesota  55440
University of Florida Department of Aging and Geriatrics Gainsville, Florida  32611
Rush Alzheimer's Disease Center Chicago, Illinois  60612
Phalen Village Clinic St. Paul, Minnesota  55106
University of Pittsburgh Health Sciences Research Center Pittsburgh, Pennsylvania  
Detroit Clinical Research Center Farmington Hills, Michigan  48336
University of Tennessee Health Science Center Memphis, Tennessee  38105
Emory/ Atlanta VAMC Atlanta, Georgia  30322
Central Jersey Medical Center Elizabeth, New Jersey  07202
The Brody School of Medicine at ECU Greenville, North Carolina  27834
University of TX Medical Branch Galveston, Texas  77555