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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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:2008-006211-21
    Sponsor's Protocol Code Number:2008.534
    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:2009-06-22
    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 number2008-006211-21
    A.3Full title of the trial
    Protection par la Ciclosporine A au cours de l’infarctus du myocarde thrombolysé : étude CICLADE
    A.3.2Name or abbreviated title of the trial where available
    CICLADE
    A.4.1Sponsor's protocol code number2008.534
    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 SponsorHospices civils de Lyon
    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 Sandimmun
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma SAS
    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 name SANDIMMUN
    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 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) 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 aigu du myocarde
    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
    Déterminer si la Ciclosporine A (CsA), administrée par voie intraveineuse au moment de la thrombolyse, permet de limiter la taille de l’infarctus du myocarde.
    E.2.2Secondary objectives of the trial
    Déterminer si la CsA permet une amélioration à 6 mois de la récupération fonctionnelle du myocarde
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients de plus de 18 ans
    hommes ou femmes,
    présentant un premier infarctus aigu du myocarde avec sus-décalage du segment ST (STEMI), avec :
     début des douleurs < 12heures
     indication de thrombolyse pré-hospitalière (estimation du délai entre la prise en charge par le SMUR et une revascularisation par angioplastie primaire estimé > 90 minutes)
    Patients ayant reçu une information claire loyale et appropriée sur l’étude et ayant signé le formulaire de recueil de consentement
    Patients ayant la capacité juridique à consentir
    Patients bénéficiaires d’un régime de sécurité sociale
    E.4Principal exclusion criteria
    Arrêt cardiaque, choc cardiogénique, antécédents d’infarctus du myocarde
    Contre-indication à la thrombolyse : antécédent d’AVC hémorragique, d’AVC ischémique < 3 mois, de traumatisme crânien récent, de néoplasie intra-cranienne connue, de chirurgie récente à haut risque hémorragique, de traitements par AVK (INR > 1,3), diathèse hémorragique connue, ulcère gastro-duodénal documenté ou saignement gastro-duodénal < 6 mois.
    Incapacité à signer le consentement éclairé
    Hypersensibilité à la Ciclosporine A connue ou à l’huile de ricin polyoxyéthylénée, patient sous millepertuis, stiripentol, bosentan ou rosuvastatine, traitements pouvant augmenter les concentrations sanguines de la Ciclosporine A par diminution de son métabolisme (diltazem, vérapamil…)
    Antécédent d’immunodépression récente (<6mois) : cancers, lymphomes, sérologie positive pour HIV, hépatite, …
    Insuffisance rénale connue, HTA incontrôlée (>180/110 mmHg malgré le traitement)
    Femme en âge de procréer, enceinte ou sans contraception
    E.5 End points
    E.5.1Primary end point(s)
    CRITERE DE JUGEMENT PRINCIPAL : LA TAILLE DE L’INFARCTUS
    Elle sera estimée par la technique d’IRM réalisée au 5ème jour ( 2 jours) post-infarctus . Elle sera également évaluée par la cinétique plasmatique des enzymes cardiaques (CPK totales et troponine I) au cours des 72 premières heures suivant l’admission en Unité de Soins Intensifs
    CRITERE DE JUGEMENT SECONDAIRE : LA RECUPERATION FONCTIONNELLE CONTRACTILE
    Elle sera appréciée par échocardiographie. Plus spécifiquement, nous quantifierons l’amélioration de la fonction contractile globale et régionale au 6ème mois ( 20 jours) post-infarctus. L’échocardiographie à 6 mois sera comparée à celle réalisée de façon courante chez tous les patients en USIC.
    CRITERE DE JUGEMENT TERTIAIRE : LES EVENEMENTS CLINIQUES
    Une consultation de cardiologie sera réalisée au 30ème jour ( 10 jours) suivant l’infarctus pour déterminer l’incidence du critère combiné constitué par les évènements suivants : décès d’origine cardiovasculaire, fibrillation ventriculaire, infarctus, angor instable, hospitalisation pour insuffisance cardiaque, accident vasculaire cérébral
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Information not present in EudraCT
    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 concerned3
    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 years
    E.8.9.1In the Member State concerned months24
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state76
    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 Decision2009-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-06
    P. End of Trial
    P.End of Trial StatusOngoing
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