TerminatedPhase 3

Aspirin to Target Arterial Events in Chronic Kidney Disease

Stopped: Planned recruitment total was not achievable within the funded timeframe

United Kingdom4,633 participantsStarted 2019-02-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Males and females aged 18 years and over at the date of screening * .Subjects with CKD (reduced eGFR and/or albuminuria) defined as: • estimated glomerular filtration rate \[eGFR\] \<60mL/min/1.73m2 for at least 90 days, and/or • kidney disease code on the GP electronic patient AND most recent eGFR in CKD-defining range (\<60mL/min/1.73m2), and/or • 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) * 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 an…

What they're measuring

Number of participants with a Major vascular event: Composite outcome of non-fatal myocardial infarction, non-fatal stroke and cardiovascular death (excluding confirmed intracranial haemorrhage and other fatal cardiovascular haemorrhage)

Timeframe: Over average 4 years follow-up

Trial details

NCT IDNCT03796156

SponsorUniversity of Southampton

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-30