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    Summary
    EudraCT Number:2013-003559-39
    Sponsor's Protocol Code Number:2011PP02
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2013-09-19
    Trial results View 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 number2013-003559-39
    A.3Full title of the trial
    Allopurinol and cardiovascular outcomes in patients with ischaemic heart disease (ALL-HEART)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Allopurinol and cardiovascular outcomes in patients with ischaemic heart disease (ALL-HEART)
    A.3.2Name or abbreviated title of the trial where available
    ALL-HEART
    A.4.1Sponsor's protocol code number2011PP02
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN32017426
    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 SponsorThe University of Dundee
    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 supportNIHR HTA
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedicines Monitoring Unit & Hypertension Research Centre (MEMO/HRC), University of Dundee
    B.5.2Functional name of contact pointAdam Wilson
    B.5.3 Address:
    B.5.3.1Street AddressLevel 7, Ninewells Hospital
    B.5.3.2Town/ cityDundee
    B.5.3.3Post codeDD1 9SY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01382383119
    B.5.5Fax number01382740209
    B.5.6E-mailadam@memo.dundee.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorNHS TAYSIDE
    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 organisationMedicines Monitoring Unit & Hypertension Research Centre (MEMO/HRC), University of Dundee
    B.5.2Functional name of contact pointAdam Wilson
    B.5.3 Address:
    B.5.3.1Street AddressLevel 7, Ninewells Hospital
    B.5.3.2Town/ cityDundee
    B.5.3.3Post codeDD1 9SY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01382383119
    B.5.5Fax number01382740209
    B.5.6E-mailAdam@memo.dundee.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.2.5The 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 nameAllopurinol
    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 INNAllopurinol
    D.3.9.1CAS number 315-30-0
    D.3.9.3Other descriptive name1,​5-​dihydro-​4H-​pyrazolo[3,​4-​d]pyrimidin-​4-​one
    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 number100 to 600
    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
    Ischaemic Heart Disease (IHD), angina or myocardial infarction
    E.1.1.1Medical condition in easily understood language
    Ischaemic heart disease is a condition in which the blood supply to the heart is reduced, usually due to atherosclerosis of the heart's blood vessels.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10023024
    E.1.2Term Ischaemic heart disease
    E.1.2System Organ Class 100000004849
    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 aim is to determine whether the addition of allopurinol 600mg daily to usual therapy in patients with ischaemic heart disease (IHD) improves cardiovascular outcomes ie reduces the risk of heart attack, stroke or death from cardiovascular disease.
    E.2.2Secondary objectives of the trial
    To determine the cost-effectiveness of adding allopurinol 600mg daily to usual therapy in patients with ischaemic heart disease.

    To determine whether the addition of allopurinol 600mg daily to usual therapy improves quality of life assessed by: General Health Survery (EQ-5D) and Coronary heart disease-specific questionaire (Seattle Angina Questionnaire)

    To determine the safety and tolerability of giving allopurinol to patients with IHD (without a history of gout).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients aged 60 years and over.
    2. Ischaemic heart disease (IHD) defined as a diagnosis of angina or myocardial infarction (MI) at any time or other evidence of ischaemic heart disease (investigator opinion).

    E.4Principal exclusion criteria
    1. History of gout
    2. Known renal impairment (eGFR <60 ml/min).
    3. Moderate to severe heart failure (NYHA III-IV).
    4. Significant hepatic disease (eg ALT >3 x upper limit of normal, cirrhosis, ascites) (investigator opinion)
    5. Patients currently taking part in another interventional clinical trial of an investigational medicinal product or medical device (or taken part in one within the last 3 months).
    6. Previous allergy to allopurinol
    7. Previous serious adverse cutaneous (skin) reaction to any drug (eg Stevens Johnson syndrome, toxic epidermal necrolysis, hospitalisation due to skin reaction to drug) (investigator opinion)
    8. Patients already taking urate lowering therapy (including allopurinol, febuxostat, sulfinpyrazone, benzbromarone, probenecid, rasburicase).
    9. Patients taking azathioprine, mercaptopurine, ciclosporin or theophylline.
    10. Malignancy (except non-metastatic, non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 5 years (investigator opinion).
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the composite (APTC) CV endpoint of non-fatal MI, non-fatal stroke and CV death determined by record-linkage. It is necessary to use a composite endpoint in this type of trial as event rates for individual events would be too low. The APTC endpoint is well-established and non-subjective.
    E.5.1.1Timepoint(s) of evaluation of this end point
    5,215 patients will be randomised to give 80% power to detect a 20% reduction in the primary CV endpoint for each intervention (allowing for 4% dropout for withdrawal of consent to follow up and for noncardiovascular deaths). A 14% event rate over 4 years average follow-up has been estimated from previous trials in similar patient groups. The study will end when 631 adjudicated primary endpoints have occurred.
    Endpoints will be adjudicated throughout the trial and a final evaluation will be carried out at the end of the trial.
    E.5.2Secondary end point(s)
    Non-fatal MI determined by record-linkage
    Non-fatal stroke determined by record-linkage
    CV death
    All-cause mortality
    All CV hospitalisations
    Hospitalisation for acute coronary syndrome (ACS) (includes hospitalisation for MI and for troponin-negative cardiac chest pain)
    Coronary revascularisation
    Hospitalisation for ACS or coronary revascularisation
    Hospitalisation for heart failure
    Quality of life (EQ-5D and Seattle Angina Questionnaire)
    Cost-effectiveness of allopurinol

    The secondary clinical outcomes were selected to include important clinical events for patients, for the NHS in terms of costs and service usage and also to capture whether allopurinol improves symptomatic endpoints, survival endpoints and endpoints related to both symptoms and survival in patients with IHD.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The study will end when 631 adjudicated primary endpoints have occurred.
    Secondary endpoints will be collected throughout the trial and a final evaluation will be carried out at the end of the trial.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 Yes
    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
    usual care with no additional therapy
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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 trial will end when 631 primary endpoints have been positively adjudicated by the endpoint committee.

    There is a 6 month period for data analysis at the end of the trial to allow for final record-linkage of events.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days31
    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: 1000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4215
    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 state5215
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 5215
    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)
    Allopurinol is not currently licensed for treatment of Ischaemic Heart Disease, so allopurinol therapy will be stopped at the end of the trial.

    This is clearly stated within the patient information sheet.
    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 Scottish Primary Care Research Network
    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 Decision2013-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-12
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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