ATTACK: Aspirin To Target Arterial events in Chronic Kidney disease
Chronic kidney disease (Stages 1-4)
Current interventions as of 11/01/2021: Eligible participants, based on prior results of blood and urine tests, will be randomised (open label randomisation) 1:1 to general practitioner (GP) prescription of aspirin (treatment arm 1) vs no prescription (and avoidance of aspirin) (treatment arm 2), stratified by age, diabetes and chronic kidney disease (CKD) severity. Treatment arm 1 will receive 75 mg aspirin (non-enteric coated) to be taken daily, whereas treatment arm 2 will receive no aspirin and will be asked to avoid aspirin. Participants will take the study medication for between 2.5 and 6 years, depending on when they are enrolled into the study. Follow-up will be until 1827 endpoints have occurred (this is anticipated 6 years after the recruitment start date, or 2.5 years following the recruitment end date). Previous interventions: Eligible participants, based on results of blood and urine tests taken at screening, will be randomised (open label randomisation) 1:1 to general practitioner (GP) prescription of aspirin (treatment arm 1) vs no prescription (and avoidance of aspirin) (treatment arm 2), stratified by age, diabetes and chronic kidney disease (CKD) severity. Treatment arm 1 will receive 75 mg aspirin (non-enteric coated) to be taken daily, whereas treatment arm 2 will receive no aspirin and will be asked to avoid aspirin. Participants will take the study medication for between 2.5 and 6 years, depending on when they are enrolled into the study. Follow-up will be until 1827 endpoints have occurred (this is anticipated 6 years after the recruitment start date, or 2.5 years following the recruitment end date).
Current inclusion criteria as of 20/03/2024: 1. Males and females aged 18 years and over at the date of screening 2. Subjects with CKD (reduced eGFR and/or albuminuria) defined as: 2.1. Estimated glomerular filtration rate [eGFR] <60mL/min/1.73m2 for at least 90 days, and/or 2.2. Kidney disease code on the GP electronic patient AND most recent eGFR in CKD-defining range (<60mL/min/1.73m2), and/or 2.3. Albuminuria or proteinuria (defined as urine albumin:creatinine ratio [ACR] ≥3mg/mmol, and/or urine protein:creatinine ratio [PCR] ≥15mg/mmol, and/or +protein or greater on reagent strip) 3. Subjects who are willing to give permission for their paper and electronic medical records to be accessed by trial investigators 4. Subjects who are willing to be contacted and interviewed by trial investigators 5. Subjects who can communicate well with the investigator or designee, understand the requirements of the study and understand and sign the written informed consent _____ Previous inclusion criteria as of 11/01/2021: 1. Aged 18 years or over at the date of screening 2. Subjects with CKD, defined by at least one of the following: 2.1. Decreased estimated glomerular filtration rate [eGFR] for at least 90 days (defined as eGFR <60mL/min/1.73m2), and/or 2.2. Albuminuria or (where there are no measurements of albuminuria) proteinuria for at least 90 days (defined as urine albumin:creatinine ratio [ACR] ≥3mg/mmol, and/or urine protein: creatinine ratio [PCR] ≥15mg/mmol , and/or +protein or greater on reagent strip [and in all cases where the most recent qualifying result is ACR ≥3mg/mmol or PCR ≥15mg/mmol]), and/or 2.3. CKD formally diagnosed/coded on the GP electronic patient AND most recent quantitative tests within last 15 months and in CKD-defining range (eGFR <60mL/min/1.73m2 and/or ACR ≥3mg/mmol, and/or PCR ≥15mg/mmol) 3. Willing to give permission for their paper and electronic medical records to be accessed and abstracted by trial investigators for the duration of
Current exclusion criteria as of 20/03/2024: 1. CKD GFR category 5 2. Pre-existing CVD: 2.1. Angina 2.2. Myocardial infarction 2.3. Stroke (ischaemic and haemorrhagic (intracerebral/subarachnoid)) 2.4. Transient ischemic attack 2.5. Significant peripheral vascular disease 2.6. Coronary or peripheral revascularisation for atherosclerotic disease 3. Pre-existing condition associated with increased risk of bleeding other than CKD: 4. Subjects currently prescribed anticoagulants or antiplatelet agent, or taking over the counter (OTC) aspirin continuously 5. Currently and regularly taking other drugs with a potentially serious interaction with aspirin 6. Known allergy to aspirin or definite previous clinically important adverse reaction to aspirin 7. Poorly controlled hypertension (latest recorded systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥105 mmHg) 8. Subjects with other conditions which in the opinion of their General Practitioner (GP) would preclude prescription of aspirin in routine clinical practice such as significant anaemia or thrombocytopenia 9. Pregnant or likely to become pregnant during the study period 10. Malignancy that is life-threatening or likely to limit prognosis, other life-threatening co-morbidity, or terminal illness 11. Behaviour or lifestyle would render them less likely to comply with study medication 13. In prison 14. Currently participating in another interventional clinical trial or who have taken part in a trial in the last 3 months _____ Previous participant exclusion criteria as of 08/01/2021: 1. CKD GFR category 5 2. Pre-existing CVD: 2.1. Angina 2.2. Myocardial infarction 2.3. Stroke (ischaemic and haemorrhagic (intracerebral/subarachnoid)) 2.4. Transient ischemic attack 2.5. Significant peripheral vascular disease 2.6. Coronary or peripheral revascularisation for atherosclerotic disease Aortic aneurysm is not an exclusion criterion 3. Pre-existing condition associated with increased risk of bleeding other th