Aspirin in Reducing Events in the Elderly "ASPREE"

Active, not recruiting

Phase 4 Results N/A

Trial Description

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.

Conditions

Interventions

  • Aspirin Drug
    Other Names: clopidogrel; combination aspirin-dipyridamole
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2; antipyretic
  • Placebo Drug
    Intervention Desc: 100 mg enteric-coated placebo
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Placebo
  • 100 mg enteric-coated aspirin Drug
    Intervention Desc: 100 mg enteric-coated aspirin, taken daily
    ARM 1: Kind: Experimental
    Label: Aspirin
    Description: 100 mg enteric-coated aspirin

Trial Design

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

Patient Involvement

Patient will be randomized to one of two arms: 1) 100 mg enteric-coated aspirin or 2) placebo drug. Patient will have a baseline physical exam, Modified Mini-Mental State Examination and Katz ADLs. Patients will be followed for 3-6 months and then reassessed.

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary endpoint is death from any cause or incident, dementia or persistent physical disability.
Secondary 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; physical disability; and major hemorrhagic events.
Secondary All-cause mortality every 3-6 months Yes
Secondary 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 every 3-6 months Yes
Secondary Fatal and non-fatal cancer, excluding non-melanoma skin cancer every 3-6 months Yes
Secondary Dementia every 3-6 months Yes
Secondary Mild Cognitive Impairment (MCI; assessed using the Modified Mini-Mental State Examination or 3MS 70 and other cognitive function measures - see below) every 3-6 months Yes
Secondary Physical disability every 3-6 months Yes
Secondary Major hemorrhagic events every 3-6 months Yes
Secondary Depression Annually No

Sponsors