Aspirin to Target Arterial Events in Chronic Kidney Disease

Who is this study for? Patients with Chronic Kidney Diseases, Cardiovascular Diseases
What treatments are being studied? Aspirin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Nottingham Digestive Diseases Centre
RECRUITING
Nottingham
Contact Information
Primary
Jennifer Dumbleton
jennifer.dumbleton@nottingham.ac.uk
00441158231053
Backup
Diane Stevenson
diane.stevenson@nottingham.ac.uk
00441158231053
Time Frame
Start Date: 2019-02-25
Estimated Completion Date: 2025-12
Participants
Target number of participants: 25210
Treatments
Experimental: Aspirin
75mg of non enteric coated or dispersible aspirin once daily added to usual medications
No_intervention: Usual care
Usual medications only
Related Therapeutic Areas
Sponsors
Leads: University of Southampton
Collaborators: Nottingham University Hospitals NHS Trust, University of Warwick, University of Nottingham, East Kent Hospitals University NHS Foundation Trust, University of Durham, Epsom and St Helier University Hospitals NHS Trust

This content was sourced from clinicaltrials.gov