Aspirin To Target Arterial Events In Chronic Kidney Disease (ATTACK)

TITLE Aspirin To Target Arterial events in Chronic Kidney Disease ACRONYM ATTACK CHIEF INVESTIGATORS Professor Hugh Gallagher Professor Paul Roderick OBJECTIVES To test the hypothesis that the addition of 75mg aspirin once daily to usual care reduces the risk of major vascular events in patients with chronic kidney disease (CKD) who do not have pre-existing cardiovascular disease (CVD) TRIAL CONFIGURATION Open label, multi-centre study SETTING Primary care SAMPLE SIZE ESTIMATE 24,684 patients (12,342 per arm). A total of 1,779 major vascular events overall are required. NUMBER OF PARTICIPANTS We expect to invite approximately 165,000 patients in order to recruit the 24,684 required. Of these 12,342 will be randomised to aspirin 75 mg once daily and 12,342 to no additional treatment. INCLUSION CRITERIA 1.Males and females aged 18+ at the date of screening 2.Subjects with diagnosed CKD: • decreased estimated glomerular filtration rate [eGFR] for at least 90 days (defined as eGFR <60mL/min/1.73m2), and/or • 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 • 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.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 EXCLUSION CRITERIA 1.Subjects with CKD GFR category 5 2.Subjects with pre-existing cardiovascular disease (angina, myocardial infarction, stroke, transient ischaemic attack, significant peripheral vascular disease, coronary or peripheral revascularisation for atherosclerotic disease) 3.Subjects with a current pre-existing condition associated with increased risk of bleeding 4.Subjects currently prescribed anticoagulants or antiplatelet agent 5.Subjects who are currently taking drugs with a clinically significant interaction with aspirin 6.Subjects with a known allergy to aspirin or a previous clinically important adverse reaction 7.Subjects with poorly controlled hypertension (latest recorded systolic blood pressure [BP] =180 mmHg and/or diastolic BP =105 mmHg) 8.Subjects with other conditions which in the opinion of their General Practitioner would preclude prescription of aspirin in routine clinical practice, for example significant anaemia or thrombocytopenia 9.Subjects who are pregnant or likely to become pregnant during the study period 10.Subjects with malignancy that is life-threatening or likely to limit prognosis, other life-threatening co-morbidity, or terminal illness 11.Subjects whose behaviour or lifestyle would render them less likely to comply with study medication 12.Subjects in prison 13.Subjects currently participating in another interventional clinical trial or who have taken part in a trial in the previous three months DESCRIPTION OF INTERVENTIONS Suitable participants will be randomised to: receive 75mg non-enteric coated aspirin once daily in addition to their usual medication; or no additional treatment DURATION OF STUDY The trial will continue until 1,779 major vascular events have occurred (this is anticipated 6 years after the recruitment start date, or 2.5 years following the recruitment end date) RANDOMISATION AND BLINDING Eligible participants will be randomised (open label randomisation) 1:1