Aspirin in Reducing Events in the Elderly (ASPREE)
Aspirin in Reducing Events in the Elderly (ASPREE)
Overall Status:
Recruiting
Brief 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 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.
Patient Qualifications:
| Min Age | Gender | Healthy Volunteers |
|---|---|---|
70 Years | Both | Accepts Healthy Volunteers |
Inclusion Criteria:
- Men and women 70 years of age and over
Exclusion Criteria:
- History of a diagnosed cardiovascular event
- Serious intercurrent illness likely to cause death within the next 5 years, such as terminal cancer or obstructive airways disease
- Current or recurrent condition with a high risk of major bleeding, for example, cerebral aneurysm
- Anemia
- Current participation in a clinical trial
- Systolic blood pressure of ≥180 mmHg and/or diastolic blood pressure of ≥105 mmHg
- History of dementia
- Severe difficulty or inability to perform any one of the 6 Katz activities of daily living
- Noncompliance to taking pill
- Absolute contraindication or allergy to aspirin
- Current continuous use of aspirin or other antiplatelet 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
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, these benefits may be offset by adverse effects, such as potential 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 outcomes 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 preventive medicine.
Central Contact Information:
If you are interested in joining ASPREE, please contact a location near you from the list below. For more information about this trial, visit the ASPREE website.
Locations:
| Map Marker | City | State | Zip Code | Status | |
|---|---|---|---|---|---|
Geolocation is 0, 0 | Site | Birmingham | Alabama | 35294 | Recruiting |
Geolocation is 0, 0 | Site | Palo Alto | California | 94301 | Recruiting |
Geolocation is 0, 0 | Site | Washington | District of Columbia | 20060 | Recruiting |
Geolocation is 0, 0 | Site | Gainsville | Florida | 32611 | Recruiting |
Geolocation is 0, 0 | Site | Atlanta | Georgia | 30322 | Recruiting |
Geolocation is 0, 0 | Site | Atlanta | Georgia | 30310 | Recruiting |
Geolocation is 0, 0 | Site | Chicago | Illinois | 60612 | Recruiting |
Geolocation is 0, 0 | Site | Iowa City | Iowa | 52242 | Recruiting |
Geolocation is 0, 0 | Site | Kansas City | Kansas | 66106 | Recruiting |
Geolocation is 0, 0 | Site | Baton Rouge | Louisiana | 70808 | Recruiting |
Geolocation is 0, 0 | Site | Ann Arbor | Michigan | 48109 | Recruiting |
Geolocation is 0, 0 | Site | Detroit | Michigan | 48202 | Active, not recruiting |
Geolocation is 0, 0 | Site | Detroit | Michigan | 48201 | Recruiting |
Geolocation is 0, 0 | Site | Novi | Michigan | 48377 | Recruiting |
Geolocation is 0, 0 | Site | Minneapolis | Minnesota | 55425 | Recruiting |
Geolocation is 0, 0 | Site | St. Paul | Minnesota | 55106 | Recruiting |
Geolocation is 0, 0 | Site | Elizabeth | New Jersey | 07202 | Recruiting |
Geolocation is 0, 0 | Site | Mineola | New York | 11501 | Recruiting |
Geolocation is 0, 0 | Site | Greensboro | North Carolina | 27408 | Recruiting |
Geolocation is 0, 0 | Site | Greenville | North Carolina | 27834 | Recruiting |
Geolocation is 0, 0 | Site | Philadelphia | Pennsylvania | 19141 | Recruiting |
Geolocation is 0, 0 | Site | Pittsburgh | Pennsylvania | 15260 | Recruiting |
Geolocation is 0, 0 | Site | Pawtucket | Rhode Island | 02860 | Recruiting |
Geolocation is 0, 0 | Site | Memphis | Tennessee | 38105 | Recruiting |
Geolocation is 0, 0 | Site | Dallas | Texas | 75390 | Recruiting |
Geolocation is 0, 0 | Site | Galveston | Texas | 77555 | Recruiting |
Geolocation is 0, 0 | Site | San Antonio | Texas | 78229 | Recruiting |
Lead Sponsor:
| Agency |
|---|
Minneapolis Medical Research Foundation |
Collaborator Sponsor:
| Agency |
|---|
National Health and Medical Research Council, Australia |
Bayer |
Monash University |
Berman Center for Outcomes and Clinical Research |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Richard Grimm, MD, PhD | Principal Investigator | Berman Center for Outcomes and Clinical Research |
John McNeil, MD | Principal Investigator | Monash University |
Study Contact:
| Name | Phone | |
|---|---|---|
Nathan J. Tessum | 612-341-7907 | |
Brenda Kirpach | 612-341-7922 |
Locations
ClinicalTrials.gov ID
NCT01038583 (follow link to view full record on ct.gov in new window)
Official Title:
Aspirin in Reducing Events in the Elderly
Study Start Date:
January 2010
Study End Date:
August 2016
Enrollment:
19000
