Aspirin in Reducing Events in the Elderly (ASPREE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Minneapolis Medical Research Foundation
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: May 16, 2014
Last verified: May 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
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 ]

Estimated Enrollment: 19000
Study Start Date: January 2010
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (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 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
  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

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

  Show 40 Study Locations
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, MD 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: 1U01AG029824-01A2
Study First Received: December 21, 2009
Last Updated: May 16, 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:
Dementia
Heart Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System 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 October 22, 2014