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Aspirin in Reducing Events in the Elderly

Information source: Minneapolis Medical Research Foundation
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Functional Disability; Dementia; Heart Disease; Stroke; Cancer; Bleeding; Depression

Intervention: 100 mg enteric-coated aspirin (Drug); Placebo (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Minneapolis Medical Research Foundation

Official(s) and/or principal investigator(s):
Richard Grimm, MD, PHD, Principal Investigator, Affiliation: Berman Center for Outcomes and Clinical Research
John McNeil, MBBS, PHD, Principal Investigator, Affiliation: Monash University

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.

Clinical Details

Official title: Aspirin in Reducing Events in the Elderly

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

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

Secondary outcome:

All-cause mortality

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

Fatal and non-fatal cancer, excluding non-melanoma skin cancer

Dementia

Mild Cognitive Impairment (MCI; assessed using the Modified Mini-Mental State Examination or 3MS 70 and other cognitive function measures - see below)

Physical disability

Major hemorrhagic events

Depression

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

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

The University of Alabama at Birmingham, Birmingham, Alabama 35294, United States

Palo Alto Medical Foundation Research Institute, Palo Alto, California 94301, United States

Howard University, Washington, District of Columbia 20060, United States

University of Florida Department of Aging and Geriatrics, Gainsville, Florida 32611, United States

Emory/ Atlanta VAMC, Atlanta, Georgia 30322, United States

Morehouse School of Medicine, Atlanta, Georgia 30310, United States

Georgia Health Sciences University, Augusta, Georgia 30912, United States

Rush Alzheimer's Disease Center, Chicago, Illinois 60612, United States

University of Iowa, Iowa City, Iowa 52242, United States

Kansas University Medical Center, Kansas City, Kansas 66106, United States

Baton Rouge General, Baton Rouge, Louisiana 70801, United States

Mary Bird Perkins Our Lady of the Lake Cancer Center, Baton Rouge, Louisiana 70809, United States

Pennington Biomedical Research Center, Baton Rouge, Louisiana 70808, United States

Mary Bird Perkins St. Tammany Parish Hospital, Covington, Louisiana 70433, United States

Mary Bird Perkins Terrebonne General Hospital, Houma, Louisiana 70360, United States

LSU Health Sciences- New Orleans, New Orleans, Louisiana 70112, United States

Tulane Medical Center, New Orleans, Louisiana 70112, United States

LSU Health Sciences- Shreveport, Shreveport, Louisiana 71130, United States

University of Michigan, Ann Arbor, Michigan 48109, United States

Henry Ford Health System, Detroit, Michigan 48202, United States

Wayne State University, Detroit, Michigan 48201, United States

Detroit Clinical Research Center, Novi, Michigan 48377, United States

Health Partners Research Foundation, Minneapolis, Minnesota 55425, United States

Phalen Village Clinic, St. Paul, Minnesota 55106, United States

Central Jersey Medical Center, Elizabeth, New Jersey 07202, United States

New Jersey Medical College, Newark, New Jersey 07103, United States

SUNY Downstate Medical Center, Brooklyn, New York 11203, United States

Winthrop University Hospital, Mineola, New York 11501, United States

Queens Cancer Medical Center, Queens, New York 11432, United States

Wake Forest University Baptist Medical Center, Greensboro, North Carolina 27408, United States

The Brody School of Medicine at ECU, Greenville, North Carolina 27834, United States

Albert Einstein Medical Center, Philadelphia, Pennsylvania 19141, United States

University of Pittsburgh Health Sciences Research Center, Pittsburgh, Pennsylvania 15260, United States

Memorial Hospital of Rhode Island, Pawtucket, Rhode Island 02860, United States

University of Tennessee Health Science Center, Memphis, Tennessee 38105, United States

Meharry Medical College, Nashville, Tennessee 57208, United States

University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75390, United States

University of TX Medical Branch, Galveston, Texas 77555, United States

Regional Academic Health Center, Harlingen, Texas 78550, United States

UT Health Science Center at San Antonio, San Antonio, Texas 78229, United States

Additional Information

Public ASPREE website

Starting date: January 2010
Last updated: December 8, 2014

Page last updated: August 20, 2015

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