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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2021-002028-19
    Sponsor's Protocol Code Number:RH-CARD-Pharma001
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-17
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2021-002028-19
    A.3Full title of the trial
    Low-dose dobutamine infusion and single-dose tocilizumab in acute myocardial infarction patients with high risk of cardiogenic shock development – a 2x2 multifactorial, double-blinded, randomized, placebo-controlled trial
    Lavdosis dobutamin infusion og en enkelt dosis Tocilizumab til patienter med høj risiko for udvikling af kardiogent shock efter akut koronart syndrom (AKS) – et 2x2 multifaktorielt, dobbelt-blindet, randomiseret, placebo-kontrolleret studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of patients with acute myocardial infarction to avoid development of cardiogenic shock and lessen the injury of the cardiac muscle with Dobutamine and / or the IL-antagonist Tocilizumab
    Behandling af patienter med akut blodprop i hjertet for at undgå udvikling af kardiogent shock og mindske skaden på hjertemusklen med Dobutamin og / eller IL-hæmmeren Tociluzimab
    A.3.2Name or abbreviated title of the trial where available
    DOBERMANN
    DOBERMANN
    A.4.1Sponsor's protocol code numberRH-CARD-Pharma001
    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 SponsorDepartment of Cardiology, Copenhagen University Hospital Rigshospitalet
    B.1.3.4CountryDenmark
    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 supportCopenhagen University Hospital Rigshospitalet
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportNovo Nordisk Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportSimon Spies Fonden
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportHelge Peetz og Verner Peetz og hustru Vilma Peetz Legat
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Cardiology, Copenhagen University Hospital Rigshospitalet
    B.5.2Functional name of contact pointKlinisk Forskningsenhed
    B.5.3 Address:
    B.5.3.1Street AddressRyesgade 53, opgang 98, afsnit 9841
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4535452664
    B.5.6E-mailginette.wedel@regionh.dk
    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 RoActemra
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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 infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTocilizumab
    D.3.9.1CAS number 375823-41-9
    D.3.9.4EV Substance CodeSUB20313
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 No
    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 Yes
    D.2.1.1.1Trade name Dobutrex®
    D.2.1.1.2Name of the Marketing Authorisation holderSTADA Nordic ApS
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOBUTAMINE
    D.3.9.1CAS number 34368-04-2
    D.3.9.4EV Substance CodeSUB06343MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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 placeboInfusion
    D.8.4Route of administration of the placeboIntravenous 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 with increased risk of Cardiogenic Shock.
    Akut myokardieinfarkt med høj risiko for kardiogent shock.
    E.1.1.1Medical condition in easily understood language
    Acute myocardial infarction presenting within 24 hours from onset of symptoms and intermidate to high risk of developing cardiogenic shock.
    Akut blodprop i hjertet med debut af symptomer inden for 24 timer og intermediær til høj risiko for kardiogent shock.
    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 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
    In the present study, we aim to investigate the effects of dobutamine infusion and a or single post-PCI intravenous (IV) dose of Tocilizumab on plasma concentration of NTproBNP as a proxy for development of hemodynamic instability / CS in patients with acute myocardial infarction (AMI) presenting < 24 hours from chest pain plus intermediate to high risk of CS assessed by the ORBI risk score (≥11 – not in overt shock at hospital admission).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to determine the effects on development of in-hospital CS and/or in-hospital cardiac arrest and/or transfer to the ICU during index admission, infarct size measured by cMRi, long-term all-cause mortality, biomarkers reflecting neurohormonal activation, endothelial function/damage, inflammation, connective tissue damage, organ dysfunction, PCI operators post-procedure clinical assessment of the patient, development of non-cardiac arrest arrythmia, 2D echocardiographic findings of hemodynamics and left ventricular function, re-admission during the first year after index hospitalization, re-admission with heart failure and re-infarction, SOFA score, quality of life and mental and cognitive health at baseline and after three months.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Acute myocardial infarction;
    Revascularization with PCI;
    Presentation within 24 hours of chest pain;
    ORBI risk score ≥ 11;
    Age ≥ 18.
    E.4Principal exclusion criteria
    Unwilling to give informed consent to study participation;
    Unable to give consent due to language barrier;
    Comatose after cardiac arrest;
    Cardiogenic shock with systolic blood pressure < 100 mmHg for more than 30 minutes or need for vasopressor to maintain blood pressure and arterial lactate > 2,5 (2,0) mmol/L developed before leaving the cath. lab.;
    Other major clinical non-coronary condition (stroke, sepsis etc.), which can explain a high ORBI risk score;
    Referral for acute coronary artery bypass grafting (CABG) (< 24 hours) after the CAG, whereas subacute (>24 hours will be included) ;
    In patients with coronary biomarkers without dynamic elevation (‘rise-and-fall’) reflecting other condition than AMI, treatment with the assigned study drug(s) will be completed and the patient will be included in sensitivity analyses but will not have MRi performed;
    Contraindications against dobutamine infusion (sustained ventricular tachycardia prior to admission or noted in the cath.lab., known pheochromocytoma, idiopathic hypertrophic subaortic stenosis);
    Tocilizumab allergy;
    Pregnant- or breastfeeding women;
    Known liver disease/dysfunction;
    Ongoing uncontrollable infection;
    Immune deficiency/treatment with immunosuppressants;
    Known, uncontrolled gastrointestinal (GI) disease predisposing to GI perforation.
    E.5 End points
    E.5.1Primary end point(s)
    NTproBNP in blood samples drawn from hospital admission to 48 hours after admission.
    E.5.1.1Timepoint(s) of evaluation of this end point
    NTproBNP will be measured on admission and at 3, 12, 24, 36 and 48 hours from admission.
    E.5.2Secondary end point(s)
    Paraclinical endpoints:
    Infarct size measured by cMRi during index admission and after 3 months;
    Biomarkers reflecting neurohormonal activation, endothelial function/damage, inflammation (pro- and anti-inflammatory processes – including IL-6 and C-reactive peptide (CRP)), connec-tive tissue damage, organ dysfunction, and other relevant processes;
    2D echocardiographic measurements of hemodynamics (VTI) and left ventricular function including strain measurements according to protocol;
    SOFA score (PaO2, FiO2, on medical ventilation, Platelets, GCS, Bilirubin, mean arterial pressure OR administration of vasoactive agents required, Creatinine, COVID-19 status).

    Clinical endpoints:
    Development of in-hospital CS and/or in-hospital cardiac arrest and/or transfer to the ICU during index admission;
    Long-term all-cause mortality;
    PCI operator’s post-procedure clinical assessment of the patient (survives to discharge ‘yes/no’);
    Development of non-cardiac arrest arrythmia (sustained ventricular tachycardia, atrial fibrillation with a frequency above 120 for more than 30 minutes) during index admission (safety);
    Re-admission (all cause and cardiovascular) during the first year after index hospitalization;
    Re-admission with heart failure and re-infarction during the first year after index hospitalization;
    Quality of Life and mental and cognitive health at baseline and after three months.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaulation of paraclinical endpoints during index admission.
    Evaluation of paraclinical endpoints at follow-up at 3 months.
    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 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 trial4
    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 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
    Last contact to the subject will be 3 months (+/- 4 weeks) after last randomization.
    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 months
    E.8.9.1In the Member State concerned days
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 Yes
    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 state100
    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 Decision2021-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-01
    P. End of Trial
    P.End of Trial StatusOngoing
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