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    Summary
    EudraCT Number:2018-000644-26
    Sponsor's Protocol Code Number:31844
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2019-02-08
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2018-000644-26
    A.3Full title of the trial
    Aspirin To Target Arterial events in Chronic Kidney Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Aspirin to target arterial events in chronic kidney disease (ATTACK)
    A.3.2Name or abbreviated title of the trial where available
    Aspirin To Target Arterial Events In Chronic Kidney Disease (ATTACK)
    A.4.1Sponsor's protocol code number31844
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Southampton
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Southampton
    B.5.2Functional name of contact pointPaul Roderick
    B.5.3 Address:
    B.5.3.1Street AddressAcademic Unit of Primary Care and Population Sciences
    B.5.3.2Town/ citySouthampton
    B.5.3.3Post codeSO16 6YD
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailpjr@soton.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.1.1.1Trade name Aspirin 75mg tablet
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAspirin 75mg tablet
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAcetylsalicylic acid
    D.3.9.1CAS number 50-78-2
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with chronic kidney disease who do not have pre-existing cardiovascular disease
    E.1.1.1Medical condition in easily understood language
    Patients with reduced kidney function or protein in the urine who have no previous history of heart attack or stroke
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the research is to test the hypothesis that low-dose (75mg non-enteric coated) aspirin reduces the risk of major vascular events (excluding confirmed intracranial haemorrhage) (primary endpoint) in people with CKD who do not have pre-existing CVD.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the research are:

    1. To assess the impact of the addition of low-dose aspirin to usual care in people with CKD and no CVD on the incidence of major intracranial and extracranial bleeds

    2. To assess the impact of the addition of low-dose aspirin to usual care in people with CKD and no CVD on the incidence of clinically relevant non-major bleeds

    3. To assess the impact of the addition of low-dose aspirin to usual care on other key secondary endpoints including: all-cause mortality; combined endpoint of major vascular events and revascularisation (coronary and non-coronary); individual components of the primary endpoint; TIA; unplanned hospitalisation; new diagnosis of cancer (colorectal/other); CKD progression; health-related quality of life (HRQoL)

    4. To examine a priori the effect of low-dose aspirin on primary and secondary endpoints in various subgroups of people with CKD: high risk and very high risk CKD as defined by KDIGO (KDIGO 2012); diabetes; age
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females aged 18 years and over at the date of screening

    2. Subjects with diagnosed CKD, defined by:
    a) estimated GFR <60mL/min/1.73m2 using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) eGFR (at least two test results with eGFR <60mL/min/1.73m2 at least 90 days apart with no values ≥60mL/min/1.73m2 in the intervening period)
    and/or:
    b) ACR ≥3mg/mmol (at least two test results in this range at least 90 days apart with no values <3mg/mmol in the intervening period). Where no historical (within the last four years) results of ACR are available, patients with a screening ACR >3mg/mmol who have a PCR ≥15mg/mmol at least 90 days before with no values of PCR <15mg/mmol in the intervening period will be eligible. Where there are no historical (within the last four years) ACR or PCR results, patients with a screening ACR >3mg/mmol who have +protein or greater on a reagent strip at least 90 days before with no reagent strip results showing negative or trace protein in the intervening period will be eligible

    3. Subjects willing to give permission for their paper and electronic medical records to be accessed and abstracted by trial investigators for the duration of the trial

    4. Subjects willing to be contacted and interviewed by trial investigators should the need arise for adverse event assessment

    5. Subjects able to communicate well with the investigator or designee, to understand and comply with the requirements of the study and to understand and sign the written informed consent
    E.4Principal exclusion criteria
    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
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the time to first major vascular event from the date of randomisation. A major vascular event is defined as a primary composite outcome of non-fatal myocardial infarction, non-fatal stroke and cardiovascular death (excluding confirmed intracranial haemorrhage). Deaths from other causes (including fatal bleeding) will be treated as competing events. Patients who do not experience a major vascular event will be censored at the date of last follow-up.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time to first major vascular event from the date of randomisation.
    E.5.2Secondary end point(s)
    SECONDARY ENDPOINTS
    The secondary endpoints are listed below. These will be time to event except health-related quality of life:

    Efficacy
    1. Death from any cause
    2. Composite outcome of major vascular event or revascularisation (coronary and non-coronary)
    3. Individual components of the primary composite endpoint
    4. Health-related quality of life

    Safety
    1. Composite outcome of intracranial haemorrhage (fatal and non-fatal), fatal extracranial haemorrhage and non-fatal major extracranial haemorrhage (adjudicated)
    2. Fatal and non-fatal (reported individually and as a composite) intracranial haemorrhage comprising:
    i) primary haemorrhagic stroke (to distinguish from haemorrhagic transformation of ischaemic stroke): a) intracerebral and b) subarachnoid haemorrhage (reported individually and a composite) (adjudicated)
    ii) other intracranial haemorrhage: a) subdural and b) extradural haemorrhage (reported as a composite) (adjudicated)
    3. Fatal and non-fatal (reported individually and as a composite) major extracranial haemorrhage: i) vascular-procedural; ii) vascular-non-procedural; iii) gastrointestinal; iv) genitourinary; v) respiratory; vi) pericardial; vii) ocular; viii) other; ix) undetermined (adjudicated)
    4. Clinically relevant non-major bleeding (adjudicated if hospitalised)

    TERTIARY ENDPOINTS
    The following exploratory endpoints will also be studied. These will be time to event except hospitalisation:
    1. Transient ischaemic attack
    2. Unplanned hospitalisation
    3. New diagnosis of cancer (colorectal/other)
    4. CKD progression
    5. New diagnosis of dementia
    E.5.2.1Timepoint(s) of evaluation of this end point
    From randomisation onwards (to time of event, except for health-related quality of life / hospitalisation
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard care
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned500
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial is defined as reaching the required number of endpoints (1827) - this is an endpoint-driven trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 7210
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18000
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25210
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25210
    F.4.2.2In the whole clinical trial 25210
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    At the end of the study, patients will be informed of its outcome, enabling them and their GP to take an evidence-based decision about future prescribing of aspirin in this patient group. If the trial supports the use of aspirin for CKD patients without previous CVD, this will represent a small amount of work (and cost) for practices, but will be appropriate as this will, by then, be the standard of care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Wessex CRN
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-09
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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