ASPirin in Reducing Events in the Elderly
- Conditions
- Mental and physical disability in the elderlyCirculatory SystemCardiovascular disease
- Registration Number
- ISRCTN83772183
- Lead Sponsor
- Monash University (Australia)
- Brief Summary
2003 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/14565783 rationale 2013 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/24113028 design 2016 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/27587328 rationale for ASPREE-D substudy 2017 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/28329340 baseline characteristics 2018 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/29097299 rationale for SNORE-ASA sub-study 2018 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/30023457 development of a standardized definition for clinically significant bleeding (added 03/07/2019) 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30221596 results (added 03/07/2019) 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30221597 results (added 03/07/2019) 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30221595 results (added 03/07/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31815652 results (added 10/12/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29976121 results (added 01/04/2020) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31881040 results (added 02/04/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32739494/ results (added 04/08/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33131315/ results (added 03/11/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32667729/ (added 26/05/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/32912103/ (added 29/06/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33754317/ (added 29/06/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34176293/ (added 29/06/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33351205/ (added 30/07/2021) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33078479/ (added 01/09/2021) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32100619/ (added 26/11/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36716780/ (added 31/01/2023) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37494038/ Secondary analysis (added 27/07/2023) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/38009310/ Secondary analysis (added 27/11/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 19114
Current inclusion criteria as of 13/01/2017:
1. African American and Hispanic men and women 65 years of age and over (in the USA), all other men and women 70 years of age and over
2. Willing and able to provide informed consent, and willing to accept the study requirements
Previous inclusion criteria:
All subjects will be aged 70 years or more and capable of attending their usual family physician's clinic and providing informed consent
Current exclusion criteria as of 13/01/2017:
1. A history of a diagnosed cardiovascular event defined as MI, congestive heart failure, angina pectoris (± nitrate use), stroke, transient ischemic attack, >50% carotid stenosis or previous carotid endarterectomy or stenting, coronary artery angioplasty or stenting, coronary artery bypass grafting, or abdominal aortic aneurysm
2. A clinical diagnosis of atrial fibrillation
3. A serious intercurrent illness likely to cause death within the next 5 years, such as terminal cancer or obstructive airways disease
4. A current or recurrent condition with a high risk of major bleeding, e.g. cerebral aneurysm or cerebral AV malformation, any bleeding diathesis, gastrointestinal malignancy, recent peptic ulcer, liver disease, esophageal varicosities, uremia, aortic aneurysm or any other condition known to be associated with a high risk of serious bleeding
5. Anemia, i.e. hemoglobin level below the normal value for the gender of the participant (males: <12 g/dL, females: <11 g/dL) (Note: Hemoglobin levels within the normal range in a participant taking therapy for anemia will not be an exclusion criterion).
6. Absolute contraindication or allergy to aspirin
7. Current participation in a clinical trial
8. Current continuous use of aspirin for secondary prevention
9. Current continuous use of other anti-platelet drug or anticoagulant
10. A systolic blood pressure =180 mmHg and / or a diastolic blood pressure =105 mmHg
11. A history of dementia or a Modified Mini-Mental State Examination (3MS) score ? 77 as measured at Visit 1: Lifestyle Profile and Screening
12. Severe difficulty or an inability to perform any one of the 6 Katz ADLs, as determined at Visit 1: Lifestyle Profile and Screening
13. Pill-taking compliance below 80% during the placebo run-in phase.
Previous exclusion criteria:
1. A history of cardiovascular morbidity defined as myocardial infarction, stroke, peripheral vascular disease, angina, transient ischaemic attack, greater than 50% carotid stenosis or previous carotid endarterectomy or stenting, coronary artery angioplasty or stenting, or coronary artery bypass grafting
2. A serious intercurrent illness likely to cause death within the next 5 years
3. A current or recurrent condition with a high risk of major bleeding e.g. cerebral aneurysm or cerebral arteriovenous (AV) malformation, any bleeding diathesis, gastrointestinal malignancy, peptic ulcer, liver disease, uraemia, aortic aneurysm or any other condition known to be associated with a high risk of serious bleeding
4. Absolute contraindication or allergy to aspirin
5. Current participation in a clinical trial
6. Current continuous use of aspirin or other anti-platelet drug or anticoagulant
7. A history of diabetes or dementia
8. In addition those who lie outside of tolerance levels of 8-104% during placebo run-in phase will not be randomised
The following criteria were added as of 14/03/2008:
9. An inability to perform independently one of the 6 Katz Activities of Daily Living (walking, bathing, dressing, transferring from chair or
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method