Mental and physical disability in the elderly Circulatory System Cardiovascular disease
Conditions
Interventions
Acetylsalicylic acid 100 mg: enteric coated unscored white tablet
Placebo of acetylsalicylic acid: enteric coated unscored white tablet with identical appearance
Sponsors
Monash University (Australia)
Eligibility
Sex/Gender
All
Age
65 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 bed, toileting, eating) 10. Pill taking compliance below 80% on tablet count during a placebo run-in phase The following criterion was amended to the below text as of 20/02/2009: 7. A history of dementia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amended 02/03/2009: 1. Death from any cause 2. Incident dementia, defined according to the Diagnostic and Statistical Manual for Mental Disorders 4th edition (DSM-IV) criteria 3. Persistent physical disability, defined as the onset of a lot of difficulty to inability to perform any one of 6 Katz Activities of Daily Living Updated as of 14/03/2008: 1. Death from any cause 2. Death from incident dementia, defined according to the Diagnostic and Statistical Manual for Mental Disorders 4th edition (DSM-IV) criteria 3. Death from persistent physical disability, defined as progression by at least 2 intervals on a 5-point scale of any one of the 6 Katz Activities of Daily Living Provided at time of registration: 1. Coronary artery disease death 2. Cardiac failure death (with coronary cause), and other coronary death 3. Cardiac failure death - due to heart failure (prior grade III-IV dyspnea New York Heart Association [NYHA]), with any defined non-coronary cause 4. Other vascular death 5. Non-coronary cardiac death 6. Cerebrovascular disease death 7. Non-fatal cardiovascular events 8. Non-fatal cerebrovascular events | — |
Secondary
| Measure | Time frame |
|---|---|
| Added 13/01/2017: Secondary outcome measures since 2009: 1. All-cause mortality 2. Fatal and non-fatal cardiovascular events including a) coronary heart disease death, b) non-fatal MI, c) fatal and non-fatal stroke, and d) any hospitalization for heart failure 3. Fatal and non-fatal cancer, excluding non-melanoma skin cancer 4. Dementia (added in 2013) 5. Mild cognitive impairment 6. Physical disability 7. Depression 8. Major hemorrhagic events Secondary outcome measures updated as of 14/03/2008: 1. All-cause mortality 2. Fatal and non-fatal cardiovascular events including: 2.1. Coronary heart disease death 2.3. Non-fatal myocardial infarction 2.3. Fatal and non-fatal stroke 2.4. Hospitalisation for heart failure 3. Fatal and non-fatal cancer, excluding non-melanomatous skin cancer 4. Dementia 5. Cognitive decline 6. Physical disability 7. Major haemorrhagic events Secondary outcome measures provided at time of registration: 1. All-cause dementia ? Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria 2. Cognitive decline - defined as 2 point decline on 3MSE supplemented by a Color Trail test 3. Clinically significant bleeding including gastrointestinal hemorrhages or hemorrhages at other sites that required transfusion, hospitalization and or surgery Current tertiary outcome measures as of 29/08/2018: 1. Cognitive function 2. Physical performance 3. Quality of life 4. Haemoglobin levels 5. Hospitalisations - total and for reasons other than endpoints 6. Urinary albumin:creatinine ratio Original tertiary outcome measures: 1. Haemorrhagic stroke 2. Transient ischaemic attack 3. Hospitalisation for unstable angina 4. Total mortality 5. Cognitive decline 6. Depression score 7. Quality of life 8. Disability 9. A fall in haemoglobin 10. Fatal and non-fatal cancer 11. Total hospitalisations 12. Hospitalisation for reasons other than primary endpoints 13. Institutionalisation 14. Cost-effectiveness of aspirin 15. Public health | — |
Countries
Australia, United States of America
Outcome results
None listed