Aspirin in Reducing Events in the Elderly (ASPREE)

This study is currently recruiting participants.

Verified April 2013 by Minneapolis Medical Research Foundation

Sponsor:

Collaborators:

National Health and Medical Research Council, Australia

Bayer

Monash University

Berman Center for Outcomes and Clinical Research

National Institute on Aging (NIA)

Information provided by (Responsible Party):

Minneapolis Medical Research Foundation

ClinicalTrials.gov Identifier:

NCT01038583

First received: December 21, 2009

Last updated: April 11, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 21, 2009

Last Updated Date

April 11, 2013

Start Date ^ICMJE

January 2010

Estimated Primary Completion Date

August 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary endpoint is death from any cause or incident, dementia or persistent physical disability. [ Time Frame: every 3-6 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01038583 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

All-cause mortality [ Time Frame: every 3-6 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 3-6 months ] [ Designated as safety issue: Yes ]
Fatal and non-fatal cancer, excluding non-melanoma skin cancer [ Time Frame: every 3-6 months ] [ Designated as safety issue: Yes ]
Dementia [ Time Frame: every 3-6 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 3-6 months ] [ Designated as safety issue: Yes ]
Physical disability [ Time Frame: every 3-6 months ] [ Designated as safety issue: Yes ]
Major hemorrhagic events [ Time Frame: every 3-6 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Aspirin in Reducing Events in the Elderly

Official Title ^ICMJE

Aspirin in Reducing Events in the Elderly

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.

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 ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Functional Disability
Dementia
Heart Disease
Stroke
Cancer
Bleeding

Intervention ^ICMJE

Drug: 100 mg enteric-coated aspirin
100 mg enteric-coated aspirin, taken daily
Drug: Placebo
100 mg enteric-coated placebo

Study Arm (s)

Active Comparator: Aspirin
100 mg enteric-coated aspirin

Intervention: Drug: 100 mg enteric-coated aspirin
Placebo Comparator: Placebo
Placebo

Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

19000

Estimated Completion Date

August 2016

Estimated Primary Completion Date

August 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

65 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Nathan J Tessum	612-341-7907	ntessum@bermancenter.org
Contact: Brenda Kirpach	612-341-7922	bkirpach@bermancenter.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01038583

Other Study ID Numbers ^ICMJE

1U01AG029824-01A2

Has Data Monitoring Committee

Yes

Responsible Party

Minneapolis Medical Research Foundation

Study Sponsor ^ICMJE

Minneapolis Medical Research Foundation

Collaborators ^ICMJE

National Health and Medical Research Council, Australia
Bayer
Monash University
Berman Center for Outcomes and Clinical Research
National Institute on Aging (NIA)

Investigators ^ICMJE

Principal Investigator:	Richard Grimm, MD, PHD	Berman Center for Outcomes and Clinical Research
Principal Investigator:	John McNeil, MD	Monash University

Information Provided By

Minneapolis Medical Research Foundation

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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