Status:
UNKNOWN
Aspirin to Target Arterial Events in Chronic Kidney Disease
Lead Sponsor:
University of Southampton
Collaborating Sponsors:
University of Nottingham
University of Warwick
Conditions:
Chronic Kidney Diseases
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Aim 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-existi...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
February 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
25210 Patients enrolled
Trial Details
Trial ID
NCT03796156
Start Date
February 25 2019
End Date
December 1 2025
Last Update
May 23 2023
Active Locations (1)
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1
Nottingham Digestive Diseases Centre
Nottingham, United Kingdom, NG72UH