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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-000840-75
    Sponsor's Protocol Code Number:D4920C00002
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-10-21
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-000840-75
    A.3Full title of the trial
    A Phase IIB, Randomized, Double blinded, Placebo controlled, Parallel
    group Study to Evaluate the Efficacy and Safety of MEDI6570 in
    Participants with a Prior Myocardial Infarction, Persistent Inflammation,
    and Elevated N terminal Prohormone Brain Natriuretic Peptide
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants
    with a Prior Heart Attack
    A.3.2Name or abbreviated title of the trial where available
    GOLDILOX-TIMI 69
    A.4.1Sponsor's protocol code numberD4920C00002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04610892
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street Address1800 Concord Pike
    B.5.3.2Town/ cityWilmington DE
    B.5.3.3Post code19803
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1302885 1180
    B.5.5Fax number---
    B.5.6E-mailinformation.center@astrazeneca.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 No
    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.3.2Product code MEDI6570
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot assigned
    D.3.9.1CAS number 2418540-63-1
    D.3.9.2Current sponsor codeMEDI6570
    D.3.9.3Other descriptive nameMEDI6570
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    D.IMP: 2
    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 No
    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.3.2Product code MEDI6570
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot assigned
    D.3.9.1CAS number 2418540-63-1
    D.3.9.2Current sponsor codeMEDI6570
    D.3.9.3Other descriptive nameMEDI6570
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    D.IMP: 3
    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 No
    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.3.2Product code MEDI6570
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot assigned
    D.3.9.1CAS number 2418540-63-1
    D.3.9.2Current sponsor codeMEDI6570
    D.3.9.3Other descriptive nameMEDI6570
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Myocardial Infarction (MI)
    E.1.1.1Medical condition in easily understood language
    Heart attack
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10030272
    E.1.2Term Old myocardial infarction
    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
    To evaluate the effect of MEDI6570 on non-calcified coronary
    atherosclerotic plaques compared with placebo
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of MEDI6570 on a surrogate biomarker of HF
    compared with placebo
    - To evaluate the effect of MEDI6570 on left ventricular systolic function
    compared with placebo
    - To evaluate the effect of MEDI6570 on left ventricular systolic function
    among participants with reduced ejection fraction (defined as < 50%)
    compared with placebo
    - To evaluate the effect of MEDI6570 on other measures of non-calcified
    coronary atherosclerotic plaque compared with placebo
    - To evaluate the immunogenicity of MEDI6570
    - To evaluate the PK of MEDI6570
    - To assess the safety and tolerability of MEDI6570 compared with
    placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Participant must provide informed consent before any study-specific
    activities are performed, must be able and willing to meet all
    requirements for
    randomization within 42 days after signing the full ICF, and must adhere
    to the schedules of activities.
    2 Women must be ≥ 40 years of age at the time of signing the ICF. Men must be ≥ 21 years of age at the time of signing the ICF.
    3 Participant must:
    (a) be 30 to 365 days after presumed type-1 (ie, due to plaque rupture
    or erosion) MI (either STEMI or NSTEMI) at the time of enrollment.
    (b) have persistent inflammation, defined as hs-CRP ≥ 1 mg/L, as measured centrally at screening Visit 1.
    4 Participant must have body mass index within the range 18 to 40
    kg/m2 inclusive.
    5 For female participants, the participant must not be pregnant or
    lactating and must be of non-childbearing potential, confirmed at
    screening Visit 1 by one of the following:
    (a) Postmenopausal, defined as amenorrhea for ≥ 12 months following
    cessation of all exogenous hormonal treatments, and with luteinizing
    hormone and follicle stimulating hormone levels in the postmenopausal
    range.
    (b) Documentation of irreversible surgical sterilization by hysterectomy,
    bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not
    considered as irreversible surgical sterilization.
    6 Participant must have an evaluable, pre-randomization CTA with
    quantifiable, non-calcified plaque, as confirmed by the core laboratory.
    Participants will be reassessed for study eligibility before study
    intervention is administered on Day 1 (Visit 3). Participants should be
    considered for a high-intensity statin based on existing guidelines for
    long-term management of patients after an MI. Participants should
    ideally be on a stable dose of lipid-lowering therapy throughout the
    treatment period of the study; therefore, efforts should be made to
    maximize statin intensity before randomization.
    The proportion of participants with an NT-proBNP value < 125 pg/mL at
    screening who can be randomized to a study intervention may be
    capped. If this proportion is capped, a baseline NT-proBNP value of ≥
    125 pg/mL will be required for inclusion in the study. During the study,
    randomization to an intervention group may also be capped within other
    specific participant subgroups.
    In addition to the inclusion criteria specified above, study participants
    may elect to take part in the Genomics Initiative; participants who chose
    to do this must provide written informed consent before samples are
    collected for the optional genetic research that supports the Genomics
    Initiative.
    E.4Principal exclusion criteria
    1 History of any clinically important disease or disorder which, in the
    opinion of the investigator, may either put the participant at risk
    because of participation in the study, or influence the results or the
    participant's ability to participate in the study.
    2 Percutaneous coronary intervention or diagnostic angiogram planned
    after screening Visit
    1. Eligible participants who have a diagnostic angiogram performed in
    the absence of undergoing a new PCI may continue screening after the
    diagnostic angiogram has been performed or may be rescreened.
    3 History of or planned coronary artery bypass grafting.
    4 Documented episode of post-MI pericarditis (eg, Dressler's Syndrome)
    in the 3 months before enrollment.
    5 Ongoing New York Heart Association Class IV (severe) HF.
    6 Increased risk of bleeding
    (a) Patients with history or presence of any bleeding disorder.
    (b) Signs of ongoing bleeding at screening (e.g., identified macroscopic
    bleeding, low hemoglobin presumed to be cased by bleeding) or high
    risk for major bleeding in accordance the Investigator's assessment.
    (c) Need for chronic therapeutic anticoagulation therapy anticipated to
    be required throughout the course of the study (short-term treatment
    with prophylactic doses of heparin/low molecular weight heparin are
    allowed).
    (d) Known severe liver disease (eg, ascites and/or clinical signs of
    coagulopathy).
    7 History or presence of any of the following:
    (a) Ongoing infection or febrile illness that in the opinion of the
    investigator may be the cause of elevated hs-CRP on screening (Visit 1).
    (b) Ongoing atrial fibrillation or flutter.
    (c) Cancer within 5 years before randomization (Day 1; Visit 3), with the exception of non-melanoma skin cancer.
    (d) Alcohol or substance abuse within 6 months before randomization
    (Day 1; Visit 3), as judged by the investigator.
    (e) Known history of hypersensitivity reactions to other biologics, to
    human IgG preparations, or to any component of MEDI6570, or ongoing
    severe allergy as judged by the investigator.
    (f) Patients with active positive results on screening for serum hepatitis
    B surface antigen, hepatitis C antibody, or HIV.
    8 Any clinically important abnormalities in clinical chemistry,
    hematology, coagulation parameters, as judged by the investigator,
    including but not limited to:
    (a) AST > 2.0 × ULN.
    (b) ALT > 2.0 × ULN.
    (c) TBL > 1.5 x ULN (unless due to Gilbert's syndrome).
    (d) Platelet count < 100000 platelets/μl.
    9 BP values at screening Visit 1:
    (a) Systolic BP < 90 mmHg or > 180 mmHg.
    (b) Diastolic BP > 100 mmHg.
    (c) Participants who are excluded based on elevated BP may be
    rescreened following adequate treatment.
    The eligibility assessment is based on measurements taken starting from
    after 5 minutes of rest; if the result is outside these limits, additional BP
    measurements can be taken over the following 5 minutes, ie, up to a
    total of 10 minutes of rest (repeated a maximum of 3 times). If the
    result is outside these limits during this period, the participant is
    considered a screen fail.
    10 Participants with any of the following contraindications to CTA:
    (a) eGFR < 50 mL/min/1.73 m2 by the Chronic Kidney Disease
    Epidemiology Collaboration equation, or end stage renal disease treated
    with kidney transplant or renal replacement therapy.
    (b) Allergy to iodinated contrast.
    (c) History of contrast-induced nephropathy.
    (d) Contraindication to nitroglycerin.
    (e) Rapid heart rate that is uncontrolled by medical therapy.
    (f) Inability to hold breath for at least 6 seconds.
    11 Receipt of any investigational device or therapy within 6 months or 5
    half-lives before screening (whichever is longer).
    This criterion does NOT apply for inactive, non-replicating COVID-19
    vaccines approved by Health Authorities or under emergency use
    authorization.
    12 Planned participation in an additional investigational study of an
    intervention or biologic before the end of the follow-up period.
    Participation in observational studies or studies without investigational
    drugs or devices is allowed.
    13 Participants who are legally institutionalized.
    14 An employee or close relative of an employee of the sponsor, the
    CRO, or the study site, regardless of the employee or close relative's
    role.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to Day 253 in non-calcified plaque volume in the
    most diseased coronary segment (NCPVMD), as measured by CTA
    imaging
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 253
    E.5.2Secondary end point(s)
    1. Relative change from baseline to Day 253 in NT-proBN (N terminal
    prohormone brain natriuretic peptide)
    2. Change from baseline to Day 253 in:
    • LVEF (Left ventricular ejection fraction)
    • GLS (Global longitudinal strain)
    as measured by echocardiography
    3. Change from baseline to Day 253 in:
    • Global non-calcified plaque volume
    • Low attenuation plaque volume
    as measured by CTA imaging
    4. • ADA (Anti-drug antibody) incidence
    • Titer
    as measured in serum during the intervention and follow-up periods
    5. MEDI6570 concentrations as measured in serum during the
    intervention and follow-up periods
    6. During the intervention and follow up periods:
    • AEs
    • Clinically important changes in:
    Vital signs
    ECGs
    Safety laboratory assessments
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. to 3. - Day 253
    4. to 6. - During the intervention and follow up periods
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, tolerability
    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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Japan
    United States
    Poland
    Netherlands
    Spain
    Czechia
    Italy
    Hungary
    Russian Federation
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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 study is defined as the date of the last visit/assessment
    (including telephone contact) of the last participant in the study
    globally.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 320
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state85
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 235
    F.4.2.2In the whole clinical trial 400
    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)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-11-08
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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