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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   38002   clinical trials with a EudraCT protocol, of which   6235   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-000952-26
    Sponsor's Protocol Code Number:
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-04
    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 number2014-000952-26
    A.3Full title of the trial
    Dual Antiplatelet Therapy to Inhibit Coronary Atherosclerosis and Myocardial Injury in Patients with Necrotic High-risk Coronary Plaque Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    DIAMOND - Dual Antiplatelet Therapy to Reduce Myocardial Injury
    A.3.2Name or abbreviated title of the trial where available
    DIAMOND - Dual Antiplatelet Therapy to Reduce Myocardial Injury
    A.4.1Sponsor's protocol code number
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02110303
    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 Edinburgh
    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 supportAstraZeneca
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Edinburgh
    B.5.2Functional name of contact pointPhilip Adamson
    B.5.3 Address:
    B.5.3.1Street AddressCentre for Cardiovascular Science
    B.5.3.2Town/ city49 Little France Crescent
    B.5.3.3Post codeEH16 4SA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01315361000
    B.5.6E-mailphiladamson.nz@gmail.com
    B.Sponsor: 2
    B.1.1Name of SponsorAcademic and Clinical Central Office for Research and Development
    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 supportAstraZeneca
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Edinburgh
    B.5.2Functional name of contact pointPhilip Adamson
    B.5.3 Address:
    B.5.3.1Street AddressCentre for Cardiovascular Science
    B.5.3.2Town/ city49 Little France Crescent
    B.5.3.3Post codeEH16 4SA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01315361000
    B.5.6E-mailphiladamson.nz@gmail.com
    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 Yes
    D.2.1.1.1Trade name Brilique
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTicagrelor
    D.3.2Product code AZD6140
    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 INNTicagrelor
    D.3.9.1CAS number 0274693-27-5
    D.3.9.3Other descriptive nameBrilique
    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 number90
    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
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Stable coronary artery disease.
    E.1.1.1Medical condition in easily understood language
    Heart disease.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10011078
    E.1.2Term Coronary artery disease
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if ticagrelor (a blood thinning medication) reduces the levels of plasma high-sensitivity troponin I (a protein in the blood that is associated with increased risk of heart attacks in the future) in patients with stable heart disease but evidence of high-risk features on heart scans.
    E.2.2Secondary objectives of the trial
    a) To determine if ticagrelor (a blood thinning medication) reduces the levels of plasma high-sensitivity troponin I (a blood test that is associated with increased risk of heart attacks in the future) in patients with stable coronary heart disease and no evidence of high-risk features on heart scans.

    b) To determine if ticagrelor reduces the level of plasma high-sensitivity troponin I (hsTnI) over 1 year

    c) To determine if ticagrelor will reduce the size of fatty deposits (plaques) or calcium (hardening) in the coronary arteries

    d) To assess the evolution of plaque rupture and recovery on PET scanning over time
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Reproducibility and Natural History of 18F Sodium Fluoride Positron Emission Tomography Assessment of the Vulnerable Plaque

    The objective of this sub-study is to confirm the reproducibility (i.e. do lesions remain consistent in demonstrating the presence or absence of tracer uptake when the scan is repeated at an interval of 1 week?) and assess the natural history (i.e. over what time period do lesions continue to demonstrate tracer uptake, and what is the rate of development of new 18F-F positive plaques?) of 18F-F PET imaging.
    E.3Principal inclusion criteria
    1) Patients aged ≥40 years with angiographically proven multivessel coronary artery disease defined as at least two major epicardial vessels with any combination of either (a) >50% luminal stenosis, or (b) previous revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery).

    2) Provision of informed consent prior to any study specific procedures

    3) Receiving aspirin
    E.4Principal exclusion criteria
    1. An acute coronary syndrome within the last 12 months
    2. An indication for dual anti-platelet therapy, such as drug eluting stent
    3. Receiving thienopyridine therapy such as clopidogrel or prasugrel
    4. Percutaneous coronary intervention or coronary artery bypass graft surgery within the last 3 months
    5. Inability or unwilling to give informed consent
    6. Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial
    7. Known hypersensitivity to ticagrelor or one of its excipients
    8. Active pathological bleeding or bleeding diathesis
    9. Significant thrombocytopenia: platelets <100 x 109 /L
    10. History of intracranial haemorrhage
    11. Moderate to severe liver impairment (Child’s Grade B or C)
    12. Maintenance therapy with strong CYP3A4 inhibitors, such as ketoconazole, nefazodone, ritonavir, indinavir, atazanavir, or clarithromycin
    13. Major intercurrent illness or life expectancy <1 year
    14. Renal dysfunction (eGFR ≤30 mL/min/1.73 m2)
    15. Contraindication to iodinated contrast agents
    16. Planned coronary revascularization or major non-cardiac surgery in the next 12 months
    17. Maintenance therapy with simvastatin or lovastatin at doses greater than 40mg daily
    18. Receiving oral anticoagulants including warfarin, rivaroxaban, dabigatran or apixaban.

    E.5 End points
    E.5.1Primary end point(s)
    Plasma high sensitivity cardiac troponin I (hsTnI) concentration in patients with coronary 18F-fluoride uptake
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after beginning treatment.
    E.5.2Secondary end point(s)
    a) Plasma hsTnI concentrations at 30 days in patients without coronary 18F-fluoride uptake.
    b) High sensitivity cardiac troponin I (hsTnI) concentration at 30 days in total study population.
    c) Plasma hsTnI concentrations at 1 year
    d) Total calcium score at 1 year
    e) Plaque volume at 1 year at the site of baseline coronary 18F-fluoride uptake
    f) Reproducibility of 18F-fluoride uptake detected on PET imaging at 1 week
    f) Natural history of 18F-fluoride uptake over 1 year
    E.5.2.1Timepoint(s) of evaluation of this end point
    a) At 30 days
    b) At 30 days
    c) At 1 year
    d) At 1 year
    e) At 1 year
    f) At 1 week
    g) At 1 year
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    There will be additional blood and data analysis following LVLS to make full use of the information gathered during the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 250
    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)
    Participants will remain eligible for use of ticagrelor for the currently recommended indications (i.e. following a heart attack). This treatment will not continue to be provided outside of this indication following completion of the study as it is not currently approved for this purpose.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-03
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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