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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Miss
Jennifer
Dumbleton
jennifer.dumbleton@nottingham.ac.uk
Prof
Hugh
Gallagher
hugh.gallagher1@nhs.net
Renal failure
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This study aims to find out whether people with chronic kidney disease (CKD) should take daily low-dose aspirin to reduce the risk of a first heart attack or stroke (cardiovascular disease, CVD).
CKD is a term used by doctors when the kidneys are not working as well as they should. It is very common and affects as many as one in eight adults in the UK. CKD is important because it is linked to a much higher chance of CVD.
CVD is usually caused by small blood clots. Aspirin thins the blood so reduces the chance that clots will form but also increases the chances of bleeding. Studies in people with previous CVD show that aspirin reduces the risk of further heart attacks and strokes, and that these benefits are much greater than the risks of bleeding. As a result, aspirin is recommended for people (both with CKD and without CKD) who already have CVD.
Here we want to determine whether aspirin should be given to people with CKD to prevent a first heart attack or stroke (primary prevention). As CVD is more common in people with CKD than in the general population we would expect aspirin to be of greater benefit, but the risks of bleeding may also be higher. Before we can recommend aspirin for primary prevention in people with CKD we need to be sure that the benefits outweigh the possible risks. The National Institute of Health and Care Excellence (NICE) therefore recommended that a definitive research study was needed.
The study will recruit adults with CKD and no previous CVD via their GP practices. Eligible patients will be allocated to receive aspirin or not. We will follow patients up for several years (electronically/questionnaires) to determine whether aspirin should be prescribed to this population in the future.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;
You can take part if:
You may not be able to take part if:
1. Subjects with CKD GFR category 5 2. Subjects with pre-existing CVD: angina, MI, stroke (ischaemic and haemorrhagic [intracerebral/subarachnoid]), TIA, significant peripheral vascular disease, coronary or peripheral revascularisation for atherosclerotic disease; aortic aneurysm is not an exclusion criterion 3. Subjects with a pre-existing condition associated with increased risk of bleeding other than CKD: upper GI bleed or peptic ulcer in the previous five years, lower GI bleed in previous twelve months, active chronic liver disease (such as cirrhosis), bleeding diathesis (investigator opinion) 4. Subjects taking over the counter aspirin continuously 5. Subjects currently prescribed anticoagulant or antiplatelet agent, including: • acenocoumarol, phenindione, warfarin • apixaban, edoxaban, rivaroxaban • argatroban, bivalirudin, dabigatran • aspirin, cangrelor, selexipag, cilostazol, clopidogrel, dipyridamole, prasugrel, ticagrelor, abciximab, eptifibatide, tirofiban, epoprostenol, iloprost • unfractionated heparin, dalteparin, enoxaparin, tinzaparin • danaparoid, fondaparinux 6. Subjects who are currently and regularly taking other drugs with a potentially serious interaction with low-dose aspirin, including: • non-steroidal anti-inflammatories (except topical preparations), including: aceclofenac, acemetacin, brcelecoxib, dexibuprofen, dexketoprofen, diclofenac (and combination diclofenac-misoprostol preparation), etodolac, etoricoxib, felbinac, fenoprofen, flurbiprofen, ibuprofen, indometacin, ketoprofen, ketorolac trometamol, mefenamic acid, meloxicam, nabumetone, naproxen (and naproxen-esomeprazole), parecoxib, phenylbutazone, piroxicam, sulindac, tenoxicam, tiaprofenic acid, tolfenamic acid • selective serotonin re-uptake inhibitors: citalopram, dapoxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline • serotonin and noradrenaline re-uptake inhibitors: duloxetine, venlafaxine • nicorandil 7. Subjects with a known allergy to aspirin or definite previous clinically important adverse reaction to aspirin 8. Subjects with poorly controlled hypertension, defined as average of three readings at screening visit of systolic BP > = 180mm Hg and/or diastolic BP > = 105mm Hg 9. Subjects with anaemia: Hb < 90g/L; or Hb < 100g/L with MCV < = 75 fL 10. Subjects who are pregnant or likely to become pregnant during the study period 11. Subjects with malignancy that is life-threatening or likely to limit prognosis, other life-threatening co-morbidity, or terminal illness 12. Subjects whose behaviour or lifestyle would render them less likely to comply with study medication (e.g. alcoholism, substance abuse, debilitating psychiatric conditions or inability to provide informed consent) 13. Subjects in prison 14. Subjects currently participating in another interventional clinical trial, or who have taken part in a trial in the last three months
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Miss
Jennifer
Dumbleton
jennifer.dumbleton@nottingham.ac.uk
Prof
Hugh
Gallagher
hugh.gallagher1@nhs.net
The study is sponsored by University of Southampton and funded by British Heart Foundation (BHF); NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 37100
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