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Aspirin to Target Arterial Events in Chronic Kidney Disease (ATTACK)

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ClinicalTrials.gov Identifier: NCT03796156
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : June 4, 2019
Sponsor:
Collaborators:
University of Nottingham
University of Warwick
Nottingham University Hospitals NHS Trust
East Kent Hospitals University NHS Foundation Trust
University of Durham
Epsom and St Helier University Hospitals NHS Trust
Information provided by (Responsible Party):
University of Southampton

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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Cardiovascular Diseases Bleeding Drug: Aspirin Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Adjudication of outcomes blinded
Primary Purpose: Prevention
Official Title: Aspirin to Target Arterial Events in Chronic Kidney Disease
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Aspirin
75mg of non enteric coated aspirin once daily added to usual medications
Drug: Aspirin
75mg low dose non enteric coated

No Intervention: Usual care
Usual medications only



Primary Outcome Measures :
  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) [ Time Frame: Over average 4 years follow-up ]

    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.



Secondary Outcome Measures :
  1. Number of participants dying from any cause [ Time Frame: Average 4 years follow-up ]
    Death from any cause

  2. Number of participants with major vascular events plus revascularisation [ Time Frame: Average 4 years follow-up ]
    Primary outcome plus coronary and non coronary arterial revascularisation. It will include open and percutaneous coronary and non-coronary (including carotid, aortic and limb) procedures (as defined in Office of Population Censuses and Surveys OPCS-4 procedure codes) and will be ascertained from Hospital Episode Statistics (HES) data.

  3. Number of participants with Non-fatal myocardial infarction [ Time Frame: Average 4 years follow-up ]
    Non-fatal myocardial infarction. Acute MI defined according to the Third Universal Definition of myocardial infarction (MI).

  4. Health-related quality of life, mean utility score [ Time Frame: Average 4 years follow-up ]
    Euroqol EQ-5D utility score derived from 5 states (scoring 1-5) converted to utility values using UK general population set

  5. Number of participants with intra-cranial haemorrhage, fatal and non fatal major extra cranial haemorrhage [ Time Frame: Average 4 years follow-up ]

    Intra-cranial haemorrhage includes intracerebral haemorrhage, subarachnoid haemorrhage, subdural haemorrhage, and extradural haemorrhage.

    Extra-cranial haemorrhage is:

    • Fatal bleeding, or
    • Symptomatic bleeding in a critical area or organ, such as intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, or
    • Bleeding that leads to the transfusion of two or more units of whole blood or red cells

    In particular, to be classified as major, bleeds in a critical area or organ should:

    • Be associated with a symptomatic clinical presentation (not following an incidental finding)
    • Be the cause of the symptoms

  6. Number of participants with Fatal and non-fatal intra-cranial haemorrhage [ Time Frame: Average 4 years follow-up ]
    Fatal and non-fatal intra-cranial haemorrhage as above

  7. Number of participants with Fatal and non-fatal major extra-cranial haemorrhage [ Time Frame: Average 4 years follow-up ]
    Fatal and non-fatal major extra-cranial haemorrhage as above

  8. Number of participants with Clinically relevant non major bleeding [ Time Frame: Average 4 years follow-up ]

    Defined in accordance with the International Society on Thrombosis and Haemostasis (ISTH) as any sign or symptom of haemorrhage (e.g. more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria:

    • Requiring medical intervention by a healthcare professional
    • Leading to hospitalisation or increased level of care
    • Prompting a face to face (i.e. not just a telephone or electronic communication) evaluation This definition includes all minor bleeding episodes that lead to medical evaluation involving direct patient contact.

  9. Number of participants with Non-fatal stroke [ Time Frame: Average 4 years follow-up ]
    Non-fatal stroke excluding confirmed intracranial haemorrhage. 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 ( including intracerebral haemorrhage and sub-arachnoid haemorrhage) which has been confirmed on appropriate imaging is excluded.

  10. Number of participants with Cardiovascular death [ Time Frame: Average 4 years follow-up ]
    Cardiovascular death (excluding confirmed intracranial haemorrhage).


Other Outcome Measures:
  1. Number of participants with transient ischaemic attack [ Time Frame: Average 4 years follow-up ]
    A transient episode of neurological dysfunction caused by focal brain spinal cord or retinal ischemia without acute infarction

  2. Number of Unplanned hospitalisations per participant [ Time Frame: Average 4 years follow-up ]
    Defined as an official admission that is for a duration greater than 24 hours or a minimum of 2 calendar days where exact time of stay is unavailable.

  3. Number of participants with new diagnosis of cancer [ Time Frame: Average 4 years follow-up ]
    Any new cancer diagnosis excluding non melanotic skin cancer

  4. Number of participants with CKD progression [ Time Frame: Average 4 years follow-up ]

    Defined as at least one of:

    • >30% fall in eGFR over two years, or
    • need for renal replacement therapy or 50% decline in eGFR, or
    • new eGFR<15mL/min/1.73m2, or
    • 25% decline in GFR together with a drop in GFR category

  5. Number of participants with new diagnosis of dementia [ Time Frame: Average 4 years follow-up ]
    Coded dementia (ICD, Read) from linked GP and hospital data



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females aged 18 years and over at the date of screening
  • Subjects with diagnosed CKD:

    • decreased estimated glomerular filtration rate [eGFR] for at least 90 days (defined as eGFR <60mL/min/1.73m2), and/or
    • albuminuria or proteinuria for at least 90 days (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 [and in all cases where the most recent qualifying result is ACR ≥3mg/mmol])
  • 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 anaemia: haemoglobin (Hb) <90g/L; or Hb <100g/L with mean cell volume (MCV) ≤75 fL
  • 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 interventional clinical trial or who have taken part in a trial in the last 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796156


Contacts
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Contact: Jennifer Dumbleton 00441158231053 jennifer.dumbleton@nottingham.ac.uk
Contact: Diane Stevenson 00441158231053 diane.stevenson@nottingham.ac.uk

Locations
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United Kingdom
Nottingham Digestive Diseases Centre Recruiting
Nottingham, United Kingdom, NG72UH
Contact: Jennifer Dumbleton    00441158231053    jennifer.dumbleton@nottingham.ac.uk   
Contact: Diane Stevenson    00441158231053    diane.stevenson@nottingham.ac.uk   
Sponsors and Collaborators
University of Southampton
University of Nottingham
University of Warwick
Nottingham University Hospitals NHS Trust
East Kent Hospitals University NHS Foundation Trust
University of Durham
Epsom and St Helier University Hospitals NHS Trust
Investigators
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Principal Investigator: Hugh Gallagher, MD Epsom and St Helier University Hospitals NHS Trust
Principal Investigator: Paul Roderick, MD University of Southampton

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Responsible Party: University of Southampton
ClinicalTrials.gov Identifier: NCT03796156     History of Changes
Other Study ID Numbers: 31844
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aspirin
Kidney Diseases
Renal Insufficiency, Chronic
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics