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    Summary
    EudraCT Number:2007-002902-23
    Sponsor's Protocol Code Number:PHRC2007-03
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-11-26
    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 number2007-002902-23
    A.3Full title of the trial
    EPOMI (ERYTHROPOIETIN IN MYOCARDIAL INFARCTION) : ESSAI RANDOMISE MULTICENTRIQUE EVALUANT L’EFFET D’UNE INJECTION D’ERYTHROPOÏETINE A LA PHASE AIGUË DE L’INFARCTUS DU MYOCARDE SUR LA TAILLE DE LA CICATRICE ET LE REMODELAGE VENTRICULAIRE GAUCHE
    A.3.2Name or abbreviated title of the trial where available
    EPOMI
    A.4.1Sponsor's protocol code numberPHRC2007-03
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU Angers, directeur général, Yvonnick Morice
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 NéoRecormon
    D.2.1.1.2Name of the Marketing Authorisation holderRoche registrationLtd-Royaume Uni
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameEpoetin beta
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Infarctus du myocarde, syndrome coronarien aigu avec susdécalage du segment ST
    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
    L’objectif principal est d'établir si une injection de 1000 UI/kg d’EPO immédiatement après une angioplastie de désobstruction réalisée dans les 6 premières heures d’un syndrome coronarien aigu avec sus-décalage du segment ST réduit la taille de l’infarctus au troisième mois.
    E.2.2Secondary objectives of the trial
    - Evaluer le remodelage ventriculaire gauche post-infarctus.
    - Evaluer le taux les événements cardio-vasculaires majeurs post-infarctus.
    - Evaluer les modifications des taux sanguins d’hémoglobine, d’hématocrite, de réticulocytes, de cytokines et progéniteurs cellulaires proangiogéniques, de microparticules circulantes ayant de potentiels effets sur la vasomotricité coronaire et l’agrégation plaquettaire
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Critères de sélection :
     Patients de sexe masculin ou féminin âgés de plus de 18 ans
     Affiliation au régime de Sécurité Sociale
     Poids compris entre 50 et 110 kg
     Syndrome coronarien aigu avec sus-décalage persistant du segment ST défini par : 1) douleur angineuse typique > 30 minutes, 2) sus-décalage du segment ST > 0,1 mV (dérivations périphériques et V5-V6) ou > 0,2 mV (dérivations précordiales V1 à V4) dans au moins 2 dérivations contiguës
     Délai entre le début des symptômes et la reperfusion : 6 heures
     Traitement par angioplastie primaire
    Critères d’inclusion (à évaluer immédiatement après l’angioplastie)
     Succès de recanalisation de l’artère coupable (sténose résiduelle : 50%, flux TIMI 2 ou 3)
     Artère de l’infarctus : Circonflexe proximale (segment 11, circonflexe dominante), IVA proximale et moyenne (segments 6 et 7) et 1er, 2ème et 3ème segment de la coronaire droite (segments 1,2,3)
     Possibilité technique d’implanter une endoprothèse
     Possibilité de réaliser l’IRM dans les 5 (+ou- 2) jours après l’angioplastie
     Accord écrit du patient après information
    E.4Principal exclusion criteria
    Critères de non sélection
     Femme enceinte, les parturientes ou les mères qui allaitent
     Femme en période d'activité génitale sans contraception efficace
     Personnes majeures faisant l’objet d’une protection renforcée, privées de liberté par décision judiciaire ou administrative, hospitalisées sans consentement ou admises dans un établissement sanitaire ou social à d’autres fins que celle de la recherche
     Personne qui n’est pas affiliée à un régime de sécurité sociale ou bénéficiaire d’un tel régime
     Personne dans une période d’exclusion relative à une autre étude biomédicale
     Patient prétraité par fibrinolyse
     Antécédent d'infarctus du myocarde avec onde Q sur l’ECG, pontage(s) aorto-coronaire(s)
     Antécédent de maladie thromboembolique (thrombose veineuse profonde, embolie pulmonaire)
     Contre-indication à l'aspirine, au clopidogrel ou aux inhibiteurs des GP-IIbIIIa
     Etat de choc cardiogénique
     Prise actuelle ou ancienne d’érythropoïétine
     Contre-indication à la prise d’érythropoïétine : Hypertension artérielle non contrôlée, hypersensibilité connue à l’acide benzoïque, insuffisance hépatique chronique, hémoglobinémie > 16g/L connue, thrombocytose connue, anémie réfractaire avec excès de blastes connue
    Insuffisance rénale connue (Clairance de la créatinine < 30mL/min)
     Cancer évolutif
     Contre-indications à l’IRM : pacemaker et défibrillateur, clip intracrânien, implants intraoculaire et intra-auriculaire, corps étranger métallique intraoculaire et claustrophobie, allergie connue au gadolinium
    Critères de non inclusion
     Refus du patient
     Apparition d’un des critères de non sélection après l’angioplastie
    E.5 End points
    E.5.1Primary end point(s)
    Critère d'évaluation principal : La taille de la nécrose myocardique mesurée par IRM cardiaque de rehaussement tardif à 3 mois de l’infarctus
     Réalisation d’une IRM dans les 5 (+ ou - 2) jours puis au 3ème mois pour analyser les volumes ventriculaires gauche, la fonction contractile, la perfusion myocardique et la taille de la cicatrice
     Prélèvements à J0, J1, J2, J3 et J10 pour le contrôle de la NFS, des plaquettes et des réticulocytes.
     Dosages des cytokines et des microparticules circulantes prévues à J0, J1, J2, J3
     Suivi clinique réalisé lors de la consultation habituelle à 3 mois
     Recueil des évènements cardio-vasculaires à 1 an par contact téléphonique
    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 No
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    stratégie thérapeutique de référence
    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 concerned7
    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 Information not present in EudraCT
    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
    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 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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state128
    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 Decision2008-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-11
    P. End of Trial
    P.End of Trial StatusOngoing
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