Aspirin in Reducing Events in the Elderly

Status unconfirmed · Has a placebo group

Conditions studied: Functional Disability, Dementia, Heart Disease, Stroke, Cancer, Bleeding, Depression

In brief

ASPREE-XT is a post-treatment, longitudinal observational follow-up study of ASPREE participants \[ASPREE Investigator Group, 2013; www.aspree.org; McNeil et al 2017\]. Although the ASPREE trial medication was ceased, the study activity was not stopped and ASPREE participants are continuing with scheduled visits and phone calls. An observational follow-up phase (ASPREE-XT), began in January, 2018. This will enable the monitoring of possible delayed effects of aspirin treatment, primarily on cancer incidence, metastases and mortality. In addition to monitoring the incidence of malignancy within the ASPREE cohort, the opportunity will be taken to observe any other residual effects of aspirin on the endpoints being monitored in the cohort. Continuity of contact with study participants is the key to retention of the cohort for any ongoing or future studies.

Key facts

Study ID

NCT01038583

Run by

Hennepin Healthcare Research Institute

People needed

19114

Starts

2010-01-01

Expected to finish

2024-04-01

Last updated by the study team

2021-04-05

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men and women
• African American and Hispanic persons age 65 or older
• Any person from another ethnic minority group and Caucasian persons age 70 or older
• Willing and able to provide informed consent, and willing to accept the study requirements

You may not qualify if…

• 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

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• Palo Alto Medical Foundation Research Institute — Palo Alto, California, United States
• Howard University — Washington D.C., District of Columbia, United States
• University of Florida Department of Aging and Geriatrics — Gainesville, Florida, United States
• Morehouse School of Medicine — Atlanta, Georgia, United States
• Emory/ Atlanta VAMC — Atlanta, Georgia, United States
• Georgia Health Sciences University — Augusta, Georgia, United States
• Rush Alzheimer's Disease Center — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
• Mary Bird Perkins Our Lady of the Lake Cancer Center — Baton Rouge, Louisiana, United States
• LSU Health Sciences- New Orleans — New Orleans, Louisiana, United States
• Tulane Medical Center — New Orleans, Louisiana, United States
• LSU Health Sciences- Shreveport — Shreveport, Louisiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Wayne State University — Detroit, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Detroit Clinical Research Center — Novi, Michigan, United States
• HealthPartners Research Institute — Minneapolis, Minnesota, United States
• Phalen Village Clinic — Saint Paul, Minnesota, United States
• Central Jersey Medical Center — Elizabeth, New Jersey, United States
• Winthrop University Hospital — Mineola, New York, United States
• Wake Forest University Baptist Medical Center — Greensboro, North Carolina, United States
• The Brody School of Medicine at ECU — Greenville, North Carolina, United States

Full record on ClinicalTrials.gov

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