Aspirin in Reducing Events in the Elderly

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

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

Phase: Phase 4

Status: 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, MD, Principal Investigator, Affiliation: Monash University

Overall contact:
Nathan J Tessum, Phone: 612-341-7907, Email: ntessum@bermancenter.org

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 70.

ASPREE will determine whether taking a daily low-dose aspirin will extend the length of a disability-free life in healthy participants aged 70 years and above.

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

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 70 years and above.

Minimum age: 70 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men and women 70 years of age and over

- 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

Nathan J Tessum, Phone: 612-341-7907, Email: ntessum@bermancenter.org

The University of Alabama at Birmingham, Birmingham, Alabama 35294, United States; Recruiting
Richard Allman, MD, Principal Investigator

University of Florida Department of Aging and Geriatrics, Gainsville, Florida 32611, United States; Recruiting
Marco Pahor, MD, Principal Investigator

Rush Alzheimer's Disease Center, Chicago, Illinois 60612, United States; Recruiting
Raj Shah, MD, Principal Investigator

University of Iowa, Iowa City, Iowa, United States; Recruiting
Michael Ernst, MD, Principal Investigator

Wayne State University, Detroit, Michigan 48201, United States; Recruiting
John Flack, MD, Principal Investigator

Henry Ford Health System, Detroit, Michigan 48202, United States; Recruiting
Abraham Thomas, MD, Principal Investigator

Health Partners Research Foundation, Minneapolis, Minnesota 55425, United States; Recruiting
Karen Margolis, MD, Principal Investigator

Phalen Village Clinic, St. Paul, Minnesota 55106, United States; Recruiting
Kevin Peterson, MD, Principal Investigator

Lovelace Clinic Foundation, Albuquerque, New Mexico 87106, United States; Recruiting
Robert White, MD, Principal Investigator

University of North Carolina Chapel Hill, Chapel Hill, North Carolina, United States; Recruiting
Jane Bizbe-Whitehead, MD, Principal Investigator

Wake Forest University Baptist Medical Center, Greensboro, North Carolina 27408, United States; Recruiting
Jamehl Demons, MD, Principal Investigator

Wake Forest School of Medicine, Winston-Salem, North Carolina 27157, United States; Recruiting
Jeff Williamson, MD, Principal Investigator

Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina 27157, United States; Recruiting
Hal Atkinson, MD, Principal Investigator

University of Pittsburgh Health Sciences Research Center, Pittsburgh, Pennsylvania, United States; Recruiting
Anne Newman, MD, MPH, Principal Investigator

University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, United States; Recruiting
Shawna Nesbitt, MD, MS, Principal Investigator

South Texas College, McAllen, Texas 78501, United States; Recruiting
Mukul Ganguli, MD, Principal Investigator

UT Health Science Center at San Antonio, San Antonio, Texas 78229, United States; Recruiting
Michael Parchman, MD, Principal Investigator

Starting date: January 2010
Last updated: October 3, 2012