Aspirin to Target Arterial Events in Chronic Kidney Disease

NCT03796156 | Terminated Phase 3 DMC

• 1 other identifier: 31844
• Study Type: interventional
• Target: 4,633
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cardiovascular Diseases; Chronic Kidney Diseases; Bleeding

Outcome Measures

Primary Outcomes (1)

• Number of participants with a Major vascular event: Composite outcome of non-fatal myocardial infarction, non-fatal stroke and cardiovascular death (excluding confirmed intracranial haemorrhage and other fatal cardiovascular haemorrhage)

  Acute MI defined according to the Third Universal Definition of myocardial infarction (MI). Acute stroke defined in accordance with the World Health Organization (WHO) definition as "rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer, with no apparent cause other than of vascular origin". This excludes cases of primary cerebral tumour, cerebral metastasis, subdural haematoma, post-seizure palsy, brain trauma and TIA. Haemorrhagic stroke (fatal and non-fatal) including intracerebral haemorrhage and SAH which has been confirmed on appropriate imaging is excluded from the primary composite endpoint and included within the secondary endpoints.

  Over average 4 years follow-up

Secondary Outcomes (11)

• Number of participants dying from any cause

  Average 4 years follow-up

• Number of participants with major vascular events plus revascularisation

  Average 4 years follow-up

• Number of participants with Non-fatal myocardial infarction

  Average 4 years follow-up

• Health-related quality of life, mean utility score

  Average 4 years follow-up

• Number of participants with intra-cranial haemorrhage, fatal and non fatal major extra cranial haemorrhage

  Average 4 years follow-up

Other Outcomes (8)

• Number of participants with transient ischaemic attack

  Average 4 years follow-up

• Number of Unplanned hospitalisations per participant

  Average 4 years follow-up

• Number of participants with new diagnosis of cancer

  Average 4 years follow-up

Study Arms (2)

Aspirin

EXPERIMENTAL

75mg of non enteric coated or dispersible aspirin once daily added to usual medications

Drug: Aspirin

Usual care

NO INTERVENTION

Usual medications only

Interventions

Aspirin DRUG

75mg low dose non enteric coated or dispersible

Aspirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Warwick: collaborator
• Nottingham University Hospitals NHS Trust: collaborator
• East Kent Hospitals University NHS Foundation Trust: collaborator
• University of Durham: collaborator
• Epsom and St Helier University Hospitals NHS Trust: collaborator
• University of Southampton: lead
• University of Nottingham: collaborator

Study Sites (1)

Nottingham Clinical Trials Unit

Nottingham, NG7 2RD, United Kingdom

Location

Related Publications (2)

• Gallagher H, Dumbleton J, Maishman T, Whitehead A, Moore MV, Fuat A, Fitzmaurice D, Henderson RA, Lord J, Griffith KE, Stevens P, Taal MW, Stevenson D, Fraser SD, Lown M, Hawkey CJ, Roderick PJ. Aspirin to target arterial events in chronic kidney disease (ATTACK): study protocol for a multicentre, prospective, randomised, open-label, blinded endpoint, parallel group trial of low-dose aspirin vs. standard care for the primary prevention of cardiovascular disease in people with chronic kidney disease. Trials. 2022 Apr 21;23(1):331. doi: 10.1186/s13063-022-06132-z.

  PMID: 35449015 DERIVED

• Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

  PMID: 35224730 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cardiovascular Diseases; Hemorrhage

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Hugh Gallagher, MD

  Epsom and St Helier University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

• Simon Fraser, MD

  University of Southampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Adjudication of outcomes blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: January 8, 2019
• Study Start: February 25, 2019
• Primary Completion: September 30, 2024
• Study Completion: September 23, 2025
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

GB (1)