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    Summary
    EudraCT Number:2019-002544-24
    Sponsor's Protocol Code Number:APHP180577
    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:2019-11-27
    Trial results View 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 number2019-002544-24
    A.3Full title of the trial
    NA
    « EVALUATION DE L’EFFICACITE DU CHLORURE DE POTASSIUM
    DANS LA PRISE EN CHARGE DES ARRETS CARDIAQUES EXTRA-HOSPITALIERS
    PAR FIBRILLATION VENTRICULAIRE REFRACTAIRE»
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    POTACREH
    A.3.2Name or abbreviated title of the trial where available
    NA
    POTACREH
    A.4.1Sponsor's protocol code numberAPHP180577
    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 SponsorASSISTANCE PUBLIQUE-HOPITAUX DE PARIS
    B.1.3.4CountryFrance
    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 supportAPHP
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE-PUBLIQUE-HOPITAUX DE PARIS
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street Address1, Avenue Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.4CountryFrance
    B.5.6E-mailsylvie.prieur@aphp.fr
    B.Sponsor: 2
    B.1.1Name of SponsorASSISTANCE PUBLIQUE-HOPITAUX DE PARIS
    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 supportAP-HP
    B.4.2CountryFrance
    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
    B.Sponsor: 3
    B.1.1Name of SponsorASSISTANCE PUBLIQUE-HOPITAUX DE PARIS
    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 supportAP-HP
    B.4.2CountryFrance
    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
    B.Sponsor: 4
    B.1.1Name of SponsorASSISTANCE PUBLIQUE-HOPITAUX DE PARIS
    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 supportAP-HP
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE-HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital Saint-Louis
    B.5.3 Address:
    B.5.3.1Street Address1, Avenue Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailsylvie.prieur@aphp.fr
    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 Chlorure de Potassium 10 % - 2 g /20 ml - solution à diluer pour perfusion
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATOIRES CHAIX ET DU MARAIS
    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 nameChlorure de potassium 10 %, solution pour perfusion
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNChlorure de potassium
    D.3.9.3Other descriptive namePOTASSIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12559MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    NA
    Patient majeur, victime d’un arrêt cardiaque extra-hospitalier d’origine cardiaque présumée, avec une fibrillation ventriculaire réfractaire malgré 3 chocs électriques externes.
    E.1.1.1Medical condition in easily understood language
    NA
    NA
    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
    NA
    L’objectif principal est d’évaluer chez des patients en arrêt cardiaque extra-hospitalier par fibrillation ventriculaire réfractaire à 3 chocs électriques externes l’efficacité d’une injection IVD de 20 mmol de chlorure de potassium sur la survie à l’admission hospitalière, c’est-à-dire sur le pourcentage de patients arrivant à l’hôpital avec une activité cardiaque spontanée efficace.
    E.2.2Secondary objectives of the trial
    NA
    Les objectifs secondaires sont, chez ces patients, d’évaluer l’efficacité d’une injection IVD de 20 mmol de chlorure de potassium sur :
    - Le retour à une activité cardiaque spontanée efficace en pré-hospitalier,
    - Le temps de retour à une activité cardiaque spontanée en pré-hospitalier,
    - La dose totale d’adrénaline administrée en pré-hospitalier,
    - Le nombre total de chocs électriques externes délivrés en pré-hospitalier,
    - Le nombre de persistances et/ou récidives de trouble du rythme nécessitant un choc électrique externe en pré-hospitalier,
    - Les paramètres hémodynamiques à l’admission à l’hôpital,
    - La survie à la sortie de l’hôpital avec un bon pronostic neurologique (Cerebral Performance Category scores 1 et 2),
    - La survie à 3 mois avec un bon pronostic neurologique (Cerebral Performance Category scores 1 et 2).
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    NA
    NA
    E.3Principal inclusion criteria
    NA
    - Patient majeur (âge supérieur ou égal à 18 ans).
    - Patient victime d’un arrêt cardiaque extra-hospitalier d’origine cardiaque présumée et présentant une fibrillation ventriculaire réfractaire malgré 3 chocs électriques externes.
    - Patient bénéficiant d’un régime d’assurance maladie.
    E.4Principal exclusion criteria
    NA
    - Grossesse avérée.
    - Incapable majeur (patient sous tutelle ou curatelle).
    - Patient n’ayant encore pas de voie veineuse fonctionnelle après réalisation des 3 chocs électriques externes.
    E.5 End points
    E.5.1Primary end point(s)
    NA
    Le critère d’évaluation principal est la survie du patient à son arrivée à l’hôpital (avec une activité cardiaque spontanée efficace).
    L’évaluation sera qualitative : présence ou absence d’une activité cardiaque spontanée efficace mesurée au moment de l’arrivée du patient dans le service hospitalier (réanimation ou salle de cathétérisme cardiaque).
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    Arrivée à l'Hôpital (survie)
    E.5.2Secondary end point(s)
    NA
    - Le retour à une activité cardiaque spontanée en pré-hospitalier.
    - Le temps de retour à une activité cardiaque spontanée en pré-hospitalier.
    - La dose totale d’adrénaline administrée en pré-hospitalier.
    - Le nombre total de chocs électriques externes délivrés en pré-hospitalier.
    - Le nombre de persistances et/ou récidives de trouble du rythme nécessitant un choc électrique externe en pré-hospitalier.
    - Les paramètres hémodynamiques à l’admission à l’hôpital.
    - La survie à la sortie de l’hôpital avec un bon pronostic neurologique (Cerebral Performance Category scores 1 et 2).
    - La survie à 3 mois avec un bon pronostic neurologique (Cerebral Performance Category scores 1 et 2).
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    3 mois
    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.6.13.1Other scope of the trial description
    NA
    NA
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.1.7.1Other trial design description
    Essai clinique prospectif non comparatif de phase II
    NA
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.3.1Comparator description
    Pas de comparateur
    NA
    E.8.2.4Number of treatment arms in the trial1
    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 concerned13
    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
    NA
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months21
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 51
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    NA
    Patient en arrêt cardiaque
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state81
    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)
    NA
    NA
    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 Decision2019-12-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-16
    P. End of Trial
    P.End of Trial StatusOngoing
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