Aspirin to Target Arterial Events in Chronic Kidney Disease

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to find out whether people with chronic kidney disease [CKD] should take low dose aspirin to reduce the risk of first heart attack or stroke (cardiovascular disease [CVD]). CKD is common and is associated with an increased risk of CVD.

CVD is caused by small blood clots and aspirin thins the blood to reduce the risk of such clots developing but it also increases the risk of bleeding.

Aspirin is recommended to prevent further CVD in people who have already had a first CVD event (so called secondary prevention). Here the investigators want to study the use of aspirin as primary prevention in people with CKD who have not had a CVD to prevent the first event, to assess whether the potential benefits exceed the risks.

Eligible patients will be recruited from their United Kingdom (UK) general practices and allocated by chance to be prescribed once daily low dose aspirin or usual care only. Follow-up will be for several years both electronically (for general practice, hospital and mortality data) and by annual questionnaires to ascertain CVD and bleeding events.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southampton
• Collaborators: East Kent Hospitals University NHS Foundation Trust; Epsom and St Helier University Hospitals NHS Trust; Nottingham University Hospitals NHS Trust; University of Durham; University of Nottingham; University of Warwick
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• Males and females aged 18 years and over at the date of screening

• 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 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])

AND /OR CKD formally diagnosed/coded on the GP electronic patient record AND most recent quantitative tests within last 15 months in CKD defining range (eGFR <60mL/min/1.73m2 and/or ACR ≥3mg/mmol, and/or PCR ≥15mg/mmol).

• Subjects who are willing to give permission for their paper and electronic medical records to be accessed by trial investigators

• Subjects who are willing to be contacted and interviewed by trial investigators

• 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

• Subjects with CKD GFR category 5

• Subjects with pre-existing cardiovascular disease (angina, myocardial infarction, stroke, transient ischaemic attack (TIA), significant peripheral vascular disease, coronary or peripheral revascularisation for atherosclerotic disease)

• Subjects with a current pre-existing condition associated with increased risk of bleeding other than CKD

• Subjects currently prescribed anticoagulants or antiplatelet agent, or taking over the counter (OTC) aspirin continuously

• Subjects who are currently and regularly taking other drugs with a potentially serious interaction with aspirin

• Subjects with a known allergy to aspirin or definite previous clinically important adverse reaction

• Subjects with poorly controlled hypertension (systolic blood pressure [BP] ≥180 mmHg and/or diastolic BP ≥105 mmHg)

• . Subjects with other conditions which in the opinion of their General Practitioner (GP) would preclude prescription of aspirin in routine clinical practice, for example significant anaemia or thrombocytopenia

• Subjects who are pregnant or likely to become pregnant during the study period

• Subjects with malignancy that is life-threatening or likely to limit prognosis, other life-threatening co-morbidity, or terminal illness

• Subjects whose behaviour or lifestyle would render them less likely to comply with study medication

• Subjects in prison

• Subjects currently participating in another interventional clinical trial or who have taken part in a trial in the last 3 months