Clinical trial · Observational
Aspirin in Reducing Events in the Elderly-Extension (ASPREE-XT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bleeding | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Dementia | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Frailty | — | UNRESOLVED | — |
| Functional Disability | — | UNRESOLVED | — |
| Heart Disease | — | UNRESOLVED | — |
| Stroke | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Aspirin
- description
- 100 mg enteric-coated aspirin
- label
- Placebo
- description
- Placebo
Primary outcomes (1)
- measure
- Death from any cause or incident dementia or permanent physical disability.
- timeFrame
- Planned 5-year time frame
- description
- These categories of disability are defined, respectively, as a) all-cause mortality, b) the assessment of dementia by DSM-IV criteria or c) the onset of 'a lot of difficulty' or 'inability' to perform independently, any one of 6 Katz ADLs.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available