Using low dose aspirin to prevent heart attacks and strokes in chronic kidney disease patients
Aspirin to Target Arterial Events in Chronic Kidney Disease
This study is testing if taking low dose aspirin can help prevent heart attacks and strokes in people with chronic kidney disease who haven't had these issues before.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 25210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southampton Academic / other |
| Locations | 1 site (Nottingham) |
| Trial ID | NCT03796156 on ClinicalTrials.gov |
What this trial studies
This study investigates whether low dose aspirin can reduce the risk of first heart attacks or strokes in individuals with chronic kidney disease (CKD) who have not previously experienced cardiovascular disease (CVD). It is an open-label, multi-centre randomized controlled trial involving over 25,000 patients from general practices in the UK. Participants will be randomly assigned to receive either daily low dose aspirin or usual care, with follow-up assessments conducted over several years to evaluate the occurrence of major vascular events. The study aims to determine if the benefits of aspirin outweigh the risks of bleeding associated with its use.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with chronic kidney disease defined by specific criteria related to kidney function and protein levels.
Not a fit: Patients with advanced chronic kidney disease (eGFR category 5) or those with pre-existing cardiovascular disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a preventive treatment option for patients with CKD to reduce their risk of cardiovascular events.
How similar studies have performed: Other studies have explored aspirin's role in cardiovascular prevention, but this specific approach in CKD patients is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 clinical trial of an investigational medicinal product or who have taken part in such a trial in the last three months (Covid-19 vaccine studies are acceptable)
Where this trial is running
Nottingham
- Nottingham Digestive Diseases Centre — Nottingham, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Hugh Gallagher, MD — Epsom and St Helier University Hospitals NHS Trust
- Study coordinator: Jennifer Dumbleton
- Email: jennifer.dumbleton@nottingham.ac.uk
- Phone: 00441158231053
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.