NCT07224347

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 19,114 (actual)
• Sponsor: Anne Murray · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Functional Disability
• Dementia
• Heart Disease
• Stroke
• Cancer
• Bleeding
• Depression
• Frailty

Timeline

• Start date: 2019-07-15
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2025-11-04
• Last updated: 2025-11-04

Locations

36 sites across 2 countries: United States, Australia