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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.
Dr
.
ATTACK study team
+44 (0)1158231451
attack@nottingham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Chronic kidney disease (Stages 1-4)
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
We are doing this research to find out whether people with chronic kidney disease (CKD) should take a daily low-dose aspirin tablet to reduce the risk of a first heart attack or stroke. 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 particularly common in older people and in those with diabetes and high blood pressure. CKD is important because it is linked to a much higher chance of heart attacks and strokes. The risk of heart attack or stroke in people with mild CKD is double the risk in people with normal kidney function. The risk increases to five times as high as CKD worsens. We therefore need to find ways to reduce these risks. Heart attacks and strokes are usually caused by small blood clots. Aspirin thins the blood. This reduces the chance that clots will form in the blood but also leads to an increased risk of bleeding. Studies in people with previous heart attacks or strokes show that aspirin reduces the risk of further attacks, 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 have already had a heart attack or stroke. Aspirin is less beneficial in preventing a first attack or stroke in the general population and is generally not recommended for this purpose. As heart attacks and strokes are far more common in people with CKD than in the general population, we would expect aspirin to be of greater benefit, but the risks may also be higher as bleeding is more common in people with reduced kidney function. Before we can recommend aspirin treatment to help a first heart attack or stroke in people with CKD, we need to be sure that the benefits of treatment outweigh the possible risks.
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:
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35449015/ (added 25/04/2022)
You can take part if:
Current inclusion criteria as of 20/03/2024:
1. Males and females aged 18 years and over at the date of screening
2. Subjects with CKD (reduced eGFR and/or albuminuria) defined as:
2.1. Estimated glomerular filtration rate [eGFR] <60mL/min/1.73m2 for at least 90 days, and/or
2.2. Kidney disease code on the GP electronic patient AND most recent eGFR in CKD-defining range (<60mL/min/1.73m2), and/or
2.3. 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)
3. Subjects who are willing to give permission for their paper and electronic medical records to be accessed by trial investigators
4. Subjects who are willing to be contacted and interviewed by trial investigators
5. Subjects who can communicate well with the investigator or designee, understand the requirements of the study and understand and sign the writte
You may not be able to take part if:
Current exclusion criteria as of 20/03/2024:
1. CKD GFR category 52. Pre-existing CVD:2.1. Angina2.2. Myocardial infarction2.3. Stroke (ischaemic and haemorrhagic (intracerebral/subarachnoid))2.4. Transient ischemic attack2.5. Significant peripheral vascular disease2.6. Coronary or peripheral revascularisation for atherosclerotic disease3. Pre-existing condition associated with increased risk of bleeding other than CKD:4. Subjects currently prescribed anticoagulants or antiplatelet agent, or taking over the counter (OTC) aspirin continuously5. Currently and regularly taking other drugs with a potentially serious interaction with aspirin6. Known allergy to aspirin or definite previous clinically important adverse reaction to aspirin7. Poorly controlled hypertension (latest recorded systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥105 mmHg)8. Subjects with other conditions which in the opinion of their General Practitioner (GP) would preclude prescription of aspirin in routine clinical practice such as significant anaemia or thrombocytopenia9. Pregnant or likely to become pregnant during the study period10. Malignancy that is life-threatening or likely to limit prognosis, other life-threatening co-morbidity, or terminal illness11. Behaviour or lifestyle would render them less likely to comply with study medication13. In prison14. Currently participating in another interventional clinical trial or who have taken part in a trial in the last 3 months
_____
Previous participant exclusion criteria as of 08/01/2021:
1. CKD GFR category 52. Pre-existing CVD:2.1. Angina2.2. Myocardial infarction2.3. Stroke (ischaemic and haemorrhagic (intracerebral/subarachnoid))2.4. Transient ischemic attack2.5. Significant peripheral vascular disease2.6. Coronary or peripheral revascularisation for atherosclerotic diseaseAortic aneurysm is not an exclusion criterion3. Pre-existing condition associated with increased risk of bleeding other than CKD: 3.1. Upper GI bleed or peptic ulcer in the previous 5 years3.2. Lower GI bleed in previous 12 months3.3. Active chronic liver disease (such as cirrhosis)3.4. Bleeding diathesis (investigator opinion)4. Taking over the counter aspirin continuously5. Currently prescribed anticoagulant or antiplatelet agents, including: 5.1. Acenocoumarol, phenindione, warfarin5.2. Pixaban, edoxaban, rivaroxaban5.3. Argatroban, bivalirudin, dabigatran5.4. Aspirin, cangrelor, selexipag, cilostazol, clopidogrel, dipyridamole, prasugrel, ticagrelor, abciximab, eptifibatide, tirofiban, epoprostenol, iloprost5.5. Unfractionated heparin, dalteparin, enoxaparin, tinzaparin5.6. Danaparoid, fondaparinux6. Currently and regularly taking other drugs with a potentially serious interaction with low-dose aspirin, including: 6.1. Non-steroidal anti-inflammatories (except topical preparations), including aceclofenac, acemetacin, celecoxib, 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-esomeprazol), parecoxib, phenylbutazone, piroxicam, sulindac, tenoxicam, tiaprofenic acid, tolfenamic acid6.2. Selective serotonin re-uptake inhibitors:citalopram, dapoxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline6.3. Serotonin and noradrenaline re-uptake inhibitors: duloxetine, venlafaxine6.4. Nicorandil7. Known allergy to aspirin or definite previous clinically important adverse reaction to aspirin8. Poorly controlled hypertension (latest recorded systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥105 mmHg)9. Subjects with other conditions which in the opinion of their General Practitioner (GP) would preclude prescription of aspirin in routine clinical practice such as significant anaemia or thrombocytopenia10. Pregnant or likely to become pregnant during the study period11. Malignancy that is life-threatening or likely to limit prognosis, other life-threatening co-morbidity, or terminal illness12. 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. In prison14. Currently participating in another interventional clinical trial or who have taken part in a trial in the last 3 months
_____
Previous participant exclusion criteria:
1. CKD GFR category 52. Pre-existing CVD:2.1. Angina2.2. Myocardial infarction2.3. Stroke (ischaemic and haemorrhagic (intracerebral/subarachnoid))2.4. Transient ischemic attack2.5. Significant peripheral vascular disease2.6. Coronary or peripheral revascularisation for atherosclerotic diseaseAortic aneurysm is not an exclusion criterion3. Pre-existing condition associated with increased risk of bleeding other than CKD: 3.1. Upper GI bleed or peptic ulcer in the previous 5 years3.2. Lower GI bleed in previous 12 months3.3. Active chronic liver disease (such as cirrhosis)3.4. Bleeding diathesis (investigator opinion)4. Taking over the counter aspirin continuously5. Currently prescribed anticoagulant or antiplatelet agents, including: 5.1. Acenocoumarol, phenindione, warfarin5.2. Pixaban, edoxaban, rivaroxaban5.3. Argatroban, bivalirudin, dabigatran5.4. Aspirin, cangrelor, selexipag, cilostazol, clopidogrel, dipyridamole, prasugrel, ticagrelor, abciximab, eptifibatide, tirofiban, epoprostenol, iloprost5.5. Unfractionated heparin, dalteparin, enoxaparin, tinzaparin5.6. Danaparoid, fondaparinux6. Currently and regularly taking other drugs with a potentially serious interaction with low-dose aspirin, including: 6.1. Non-steroidal anti-inflammatories (except topical preparations), including aceclofenac, acemetacin, celecoxib, 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-esomeprazol), parecoxib, phenylbutazone, piroxicam, sulindac, tenoxicam, tiaprofenic acid, tolfenamic acid6.2. Selective serotonin re-uptake inhibitors:citalopram, dapoxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline6.3. Serotonin and noradrenaline re-uptake inhibitors: duloxetine, venlafaxine6.4. Nicorandil7. Known allergy to aspirin or definite previous clinically important adverse reaction to aspirin8. Poorly controlled hypertension, defined as average of three readings at screening visit of systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥105 mm Hg9. Anaemia (Hb <90 g/L or Hb <100 g/L with MCV ≤75 fL)10. Pregnant or likely to become pregnant during the study period11. Malignancy that is life-threatening or likely to limit prognosis, other life-threatening co-morbidity, or terminal illness12. 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. In prison14. Currently participating in another interventional clinical trial or who have taken part in a trial in the last 3 months
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.
Dr
.
ATTACK study team
+44 (0)1158231451
attack@nottingham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Southampton and funded by National Institute for Health Research; British Heart Foundation.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
