Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-000664-31
    Sponsor's Protocol Code Number:D169DC00001
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-05-11
    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 ConcernedSweden - MPA
    A.2EudraCT number2020-000664-31
    A.3Full title of the trial
    A Registry-based, Randomised, Double-blind, Placebo-Controlled
    Cardiovascular Outcomes Trial to Evaluate the Effect of Dapagliflozin on Cardiometabolic Outcomes in Patients without Diabetes with Acute Myocardial Infarction at Increased Risk for Subsequent Development of Heart Failure
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dapagliflozin effects on cardiometabolic outcomes in patients with an acute heart attack.
    A.3.2Name or abbreviated title of the trial where available
    DAPA-MI
    A.4.1Sponsor's protocol code numberD169DC00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04564742
    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 pointClinical Study Information Center
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountryUnited States
    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 Yes
    D.2.1.1.1Trade name Forxiga
    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 nameDapagliflozin
    D.3.4Pharmaceutical form Film-coated 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 INNDAPAGLIFLOZIN PROPANEDIOL
    D.3.9.1CAS number 960404-48-2
    D.3.9.3Other descriptive nameDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboFilm-coated tablet
    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
    Acute Myocardial Infarction, Heart failure
    E.1.1.1Medical condition in easily understood language
    Heart attack, reduced function of the heart muscle
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    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 whether the clinical benefit of dapagliflozin 10 mg once
    daily (QD) is superior in relation to placebo when added to SoC in
    patients without diabetes with myocardial infarction and impaired left
    ventricular systolic function during the index MI hospitalisation. Clinical
    benefit is reduced risk of Death, Heart Failure, non-fatal MI, AF/flutter,
    new onset of T2DM, symptoms of HF as measured by NYHA class, as well
    as reduced Body weight, in relation to placebo
    E.2.2Secondary objectives of the trial
    -To determine whether the clinical benefit of dapagliflozin 10 mg once
    daily (QD) is superior in relation to placebo when added to SoC. Clinical
    benefit is reduced risk of Death, Heart Failure, non-fatal MI, AF/flutter,
    new onset of T2DM and symptoms of HF as measured by NYHA class, in
    relation to placebo
    -To demonstrate the superiority of dapagliflozin 10 mg once daily (QD)
    versus dapagliflozin 10 mg placebo to match in reducing the incidence of
    CV death or HHF when added to SoC
    -To determine whether dapagliflozin 10 mg QD is superior to placebo in
    reducing:
    - MI, stroke or CV death (MACE) when added to SoC
    - the incidence of CV death when added to SoC
    - the incidence of fatal or non-fatal MI when added to SoC
    - the incidence of new onset T2DM in MI patients when added to SoC
    - Body Weight when added to SoC
    - the incidence of hospitalisation for any cause when added to SoC
    - the incidence of all-cause mortality when added to SoC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant must be ≥18 at the time of signing the informed consent.
    2 Confirmed MI, either STEMI or NSTEMI, according to the fourth
    universal definition of MI (Thygesen et al 2019), within the preceding 7
    days, or 10 days if earlier randomisation is not feasible.
    3. Evidence of impaired regional or global LV systolic function at any timepoint during current MI-related hospitalisation (established with
    echocardiogram, radionuclide ventriculogram, contrast angiography or
    cardiac MRI) OR definitive evidence on ECG of Q wave MI (defined as
    presence of Q waves in 2 or more contiguous leads, excluding leads III
    and aVR, and meeting all the following criteria: at least 1.5mm in depth;
    at least 30 ms in duration; and, if R wave present, more than 25% of the
    size of the subsequent R wave).
    4. Haemodynamically stable at randomisation (no episodes of
    symptomatic hypotension, or arrhythmia with haemodynamic
    compromise in the last 24 hours).
    5. Male or female
    6. Capable of giving signed informed consent which includes compliance
    with the requirements and restrictions listed in the informed consent
    form (ICF) and in the protocol
    7. Provision of signed and dated, written informed consent prior to any
    mandatory study specific procedures, sampling, and analyses.
    E.4Principal exclusion criteria
    1. Known T1DM or T2DM at the time for admission. Patients with
    hyperglycaemia, but without a diagnosis of diabetes mellitus prior to the
    index event, are eligible at the discretion of the Investigator. Patients
    who present with signs and symptoms consistent with ketoacidosis,
    including nausea, vomiting, abdominal pain, malaise and shortness of
    breath should be assessed for ketoacidosis, and if ketoacidosis is
    confirmed the patient should not be randomized.
    2. Chronic symptomatic HF with a prior HHF within the last year and
    known reduced ejection fraction (LVEF≤40 %), documented before the
    current MI hospitalization.
    3. Severe (eGFR <20 mL/min/1.73 m2 by local laboratory), unstable or
    rapidly progressing renal disease at the time of randomization.
    4. Severe hepatic impairment (Child-Pugh class C) at the time of
    inclusion into the trial.
    5. Active malignancy requiring treatment at the time of screening,
    except for basal cell- or squamous cell carcinoma of the skin, presumed
    possible to treat successfully.
    6. Any non-CV condition, eg malignancy, with a life expectancy of less
    than two years based on the investigator´s clinical judgement.
    7. Currently on treatment, or with an indication for treatment, with a
    SGLT2-inhibitor.
    8. Known intolerance to dapagliflozin
    9. Participation in another study with a non-approved investigational
    drug or blinded treatment with a CV or glucose lowering medication.
    10. Involvement in the planning and/or conduct of the study (applies to
    AZ staff, UCR staff and/or staff at the study site).
    11. Judgement by the investigator that the participant should not
    participate in the study if the participant is unlikely to comply with study
    procedures, restrictions and requirements, or any condition in the
    opinion of the Investigator that would make participation unsafe or
    unsuitable.
    12. Previous randomisation in the present study.
    13. Women of childbearing potential (ie, those who are not chemically
    or surgically sterilised or postmenopausal):
    (a) Who are not willing to use a highly effective method of
    contraception (described below), OR
    (b) Who have a positive pregnancy test, OR
    (c) Who are breast-feeding.
    E.5 End points
    E.5.1Primary end point(s)
    The hierarchical composite endpoint of:
    1. Death (first CV death, followed by non-CV death)
    2. Hospitalisation due to heart failure (first adjudicated, followed by
    investigator reported)
    3. Non-fatal MI
    4. AF/flutter event
    5. New onset of T2DM
    6. NYHA class at last visit
    7. Body weight decrease of at least 5% at last visit
    E.5.1.1Timepoint(s) of evaluation of this end point
    Last Subject Last Visit
    E.5.2Secondary end point(s)
    - The hierarchical composite endpoint of:
    1. Death (first CV death, followed by non-CV death)
    2. Hospitalisation due to heart failure (first adjudicated, followed by
    investigator reported)
    3. Non-fatal MI
    4. AF/flutter event
    5. New onset of T2DM
    6. NYHA class at last visit
    -Time to the first occurrence of any of the components of this composite:
    • HHF
    • CV death
    -Time to the first occurrence of any of the components of this composite:
    • MI
    • Stroke (incl. ischaemic, haemorrhagic and undetermined stroke)
    • CV death
    -Time to CV death
    -Time to the first occurrence of a fatal or a non-fatal MI
    -Time to new onset of T2DM
    -Change from baseline in Body weight
    -Time to hospitalisation for any cause
    -Time to death of any cause
    E.5.2.1Timepoint(s) of evaluation of this end point
    Last Subject Last Visit
    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 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 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) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Registry-based
    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 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 concerned39
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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
    Sweden
    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 study is defined as the last visit of the last subject undergoing the study.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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.1.1.1In 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: 2250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1750
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state1750
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1750
    F.4.2.2In the whole clinical trial 4000
    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 Decision2020-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-07-05
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sat Apr 20 09:41:37 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA