Aspirin in Reducing Events in the Elderly (ASPREE)
This study is currently recruiting participants.
Verified April 2013 by Minneapolis Medical Research Foundation
Sponsor:
Minneapolis Medical Research Foundation
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: April 11, 2013
Last verified: April 2013
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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 3-6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 19000 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | August 2016 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038583
Show 27 Study Locations
Contacts
| Contact: Nathan J Tessum | 612-341-7907 | ntessum@bermancenter.org |
| Contact: Brenda Kirpach | 612-341-7922 | bkirpach@bermancenter.org |
Show 27 Study LocationsSponsors 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: | April 11, 2013 |
| 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 Hemorrhage Stroke Brain Diseases Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Cardiovascular Diseases Pathologic Processes Cerebrovascular Disorders Vascular Diseases Aspirin Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013