Aspirin in Reducing Events in the Elderly

• Status: Active, not recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hennepin Healthcare Research Institute; Minneapolis Medical Research Foundation
• Collaborators: Bayer; Berman Center for Outcomes and Clinical Research; Monash University; National Cancer Institute (NCI); National Health and Medical Research Council, Australia; National Institute on Aging (NIA)
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• 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

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