Aspirin in Reducing Events in the Elderly-Extension (ASPREE-XT)

Aspirin in Reducing Events in the Elderly-Extension (ASPREE-XT)

ASPREE-XT is a post-treatment, longitudinal observational follow-up study of ASPREE participants. 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.

ASPREE-XT is a longitudinal, observational follow-on study of ASPREE participants.

The methodology of ASPREE-XT is based closely on ASPREE [ASPREE investigator group, 2013; www.aspree.org; McNeil et al. 2017]. Clinical, neurocognitive and physical function measurements, questionnaires for mood, quality of life, physical ability and collection of personal health, demographic and lifestyle details are the same in ASPREE-XT as those conducted and described for ASPREE.

Since ASPREE-XT is an observational study, the endpoints for ASPREE will be collected and adjudicated in a similar way for ASPREE-XT but will be referred to as ASPREE-XT Outcomes. These will not be divided into primary and secondary endpoints.

In 2018, participants were invited to enroll in ASPREE-XT. At the first ASPREE-XT study visit, or via mail, they were provided with an information sheet and consent form for the study Participants who wish to only be contacted by phone were provided with information and a consent form by mail with health and other study data collected by phone call.

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