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    Summary
    EudraCT Number:2018-002161-19
    Sponsor's Protocol Code Number:13062017-23-1
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-12-14
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-002161-19
    A.3Full title of the trial
    Dual Antiplatelet Therapy For Shock Patients With Acute Myocardial Infarction
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dual Antiplatelet Therapy For Shock Patients With Acute Myocardial Infarction
    A.3.2Name or abbreviated title of the trial where available
    DAPT-SHOCK-AMI study (PRAGUE-23)
    A.4.1Sponsor's protocol code number13062017-23-1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03551964
    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 SponsorUniverzity Hospital Královské Vinohrady
    B.1.3.4CountryCzechia
    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 supportCharles University "Progress Q 38"
    B.4.2CountryCzechia
    B.4.1Name of organisation providing supportCharles University "Research support Donatio Universitatis Carolinae"
    B.4.2CountryCzechia
    B.4.1Name of organisation providing supportCzech Health Research Council "NV19-02-00086"
    B.4.2CountryCzechia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniverzity Hospital Královské Vinohrady
    B.5.2Functional name of contact pointProf. MUDr. Zuzana Motovska, Ph.D.
    B.5.3 Address:
    B.5.3.1Street AddressSrobarova 1150/50
    B.5.3.2Town/ cityPrague
    B.5.3.3Post code100 34
    B.5.3.4CountryCzechia
    B.5.4Telephone number00420267163760
    B.5.6E-mailzuzana.motovska@fnkv.cz
    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 Kengrexal
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi Farmaceutici S.p.A.
    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.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboPowder for concentrate for solution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated 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
    Cardiogenic shock in acute myocardial infarction
    E.1.1.1Medical condition in easily understood language
    Myocardial infarction
    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 PT
    E.1.2Classification code 10007625
    E.1.2Term Cardiogenic shock
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10000891
    E.1.2Term Acute myocardial infarction
    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
    Comparison of parenteral cangrelor to the recommended ticagrelor treatment in ADP-induced platelet aggregation.
    Comparison of parenteral cangrelor to the recommended ticagrelor treatment comparing an occurence of large cariovascular events in patients with cardiogenic shock in acute myocardial infarction.
    E.2.2Secondary objectives of the trial
    Occurence of death/ Myocardial infarction/ urgent myocardial revasularization/ stroke/ major bleeding as per BARC definition
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age more than 18
    2. Acute myocardial infarction as per ESC/ACC/AHA indicated to emergency percutaneous coronary intervention (primary PCI strategy)
    3. Cardiogenic shock resulting from acute myocardial infarction in admission (occurence of two or more of the following criteria):
    - systolic blood preassure < 90mmHg
    - necessity of vasopressor and/or inotropes use
    - signs of organ perfusion - cyanosis, cold body extremities, impaired consciousness, congestive heart failure
    4. Signed informed consent
    5. Women of childbearing potential should be protected from pregnancy and use a highly effective method of contraception throughout the study (relevant for long-term use of ticagrelor). Suitable methods of contraception in this case include: combined hormonal contraception (oral, vaginal or transdermal form), gestagen hormonal contraception associated with ovulation inhibition (oral or injectable form), non-hormonal intrauterine device, intrauterine hormone-releasing device, bilateral tubal occlusion, sexual abstinence or complete withdrawal – as long as it is consistent with the patient´s lifestyle
    E.4Principal exclusion criteria
    1. Contraindication to anti-platelet ticagrelor/cangrelor treatment
    - recent (< 6 months) major bleeding
    -recent (< 1 month) major surgery/injury
    -intracranial bleeding in anamnesis
    -stroke/TIA in anamnesis
    -Ticagrelor/Cangrelor intolerance and hypersensitivity to any of the excipients of the investigational medicinal products and to excipients of the placebos
    -serious liver indeficiency
    -concomitant use of CYP3A4 inhibitor (eg. ketokonazole, clarithromycin, nefazodon, ritonavir, atazanavir)
    2. Oral use of P2Y12 inhibitor before admission (Clopidogrel ≥ 300mg, Ticagrelor 180 mg, Prasugrel 60 mg)
    3. Necessity of concomitant chronic anticoagulant treatment for atrial fibrillation, artificial valve, tromboembolism etc.)
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of parenteral cangrelor to the recommended ticagrelor treatment in ADP-induced platelet aggregation.
    Comparison of parenteral cangrelor to the recommended ticagrelor treatment comparing an occurence of large cariovascular events in patients with cardiogenic shock in acute myocardial infarction.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after enrolment.
    E.5.2Secondary end point(s)
    Occurence of death/ Myocardial infarction/ urgent myocardial revasularization/ stroke/ major bleeding as per BARC definition
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 30 and 1 year after enrolment.
    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 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) 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 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) Yes
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years6
    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.1.1.1In 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: 275
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 275
    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 Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Considering the followed diagnosis it may happen that there will be unconscious subjects included. A need of witness is described in the protocol.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 550
    F.4.2.2In the whole clinical trial 550
    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)
    The trial follows a common clinical practice, after the subject´s participation the treatment will continue in the same way .
    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 Decision2021-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2025-01-17
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