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    Summary
    EudraCT Number:2013-002714-12
    Sponsor's Protocol Code Number:RBHP2013MOTREFF
    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:2015-12-09
    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 number2013-002714-12
    A.3Full title of the trial
    Effets très précoces d’une dose de charge de rosuvastatine sur la fonction endothéliale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effets très précoces d’une dose de charge de rosuvastatine sur la fonction endothéliale
    A.3.2Name or abbreviated title of the trial where available
    STATEND
    A.4.1Sponsor's protocol code numberRBHP2013MOTREFF
    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 SponsorCHU DE CLERMONT FERRAND
    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 supportCHU DE CLERMONT FERRAND
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU DE CLERMONT FERRAND
    B.5.2Functional name of contact pointATTACHE DE RECHERCHE CLINIQUE
    B.5.3 Address:
    B.5.3.1Street Address58 RUE MONTALEMBERT
    B.5.3.2Town/ cityCLERMONT FERRAND
    B.5.3.3Post code63000
    B.5.3.4CountryFrance
    B.5.4Telephone number3304 73 754 962
    B.5.5Fax number3304 73 754 730
    B.5.6E-mailggouby@chu-clermontferrand.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 CRESTOR
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA
    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.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameROSUVASTATIN CALCIUM
    D.3.9.4EV Substance CodeSUB20721
    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 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 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
    Seront recrutés tous sujets naïfs de traitement par statine hospitalisés en USIC du CHU Gabriel-Montpied de Clermont-Ferrand, en raison d’un SCA ST- confirmé par un cardiologue, nécessitant une coronarographie sans urgence, dans les 72 heures.
    E.1.1.1Medical condition in easily understood language
    Patient présentant un syndrome coronarien aigu nécessitant la réalisation d'une coronarographie et la prise de statine.
    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
    Etudier les effets très précoces d’une dose de charge de rosuvastatine, en administration unique, sur la fonction endothéliale évaluée par une vasodilatation brachiale post-ischémique (FMD)
    E.2.2Secondary objectives of the trial
    1- Comparer l’efficacité de la rosuvastatine au placebo sur les microparticules endothéliales (MPE) par cytométrie de flux
    2- Comparer l’efficacité de la rosuvastatine au placebo sur la pression centrale par SphygmoCor®.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1- Patients admis en service de cardiologie pour syndrome coronarien aigu sans sus-décalage du segment ST, et naïfs de traitement par statine.
    2- Agés de 18 à 70 ans
    3- Ayant accepté de participer à l’étude et signé le consentement éclairé.
    4- Couverts par le régime français de Sécurité Sociale et parlant français.
    E.4Principal exclusion criteria
    1- Patient d’âge < 18ans ou > 70 ans
    2- Antécédent de traitement par statine au long cours.
    3- Insuffisance rénale sévère (Clairance de la créatinine < 30ml/min) ou affection hépatique évolutive
    4- Hypersensibilité à la rosuvastatine.
    5- Grossesse, allaitement, ou chez les femmes n’utilisant pas de moyens contraceptifs en âge de procréer
    6- Sujet atteint de cancer, de maladie mentale ou toute autre pathologie sévère pouvant selon le médecin investigateur retentir sur le consentement éclairé et/ou sur les résultats obtenus
    E.5 End points
    E.5.1Primary end point(s)
    La FMD (Flow Mediated Dilatation):
    En effet, toutes les pathologies cardiovasculaires sont associées à des modifications fonctionnelles endothéliales qui peuvent participer aux variations du tonus vasomoteur, mais aussi jouer un rôle majeur dans le déclenchement des phénomènes inflammatoires conduisant au développement de l’athérosclérose.
    Il est possible d’évaluer de manière non invasive la dysfonction endothéliale en mesurant, après induction d’une hyperémie réactive, la vasodilatation dépendante du débit (FMD) au niveau des artères périphériques (artère brachiale par Echographie Doppler).
    L’étude de la FMD chez des patients coronariens s’avère donc être un excellent moyen d’évaluer leur dysfonction endothéliale.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Mesure de la FMD par écho-doppler avant et 4h après l’administration de la rosuvastatine ou placebo
    E.5.2Secondary end point(s)
    1- Dosage des microparticules endothéliales (MPE)

    2- Evaluation de la pression central (Aortic SP (Systolic Pressure), aortic PP (Pulse Pressure) et index d'augmentation)

    Les techniques d'étude de l'onde de pouls sont un moyen pratique et efficace pour quantifier la pression pulsée centrale et la rigidité des artères principales. Elle est aujourd'hui largement utilisée pour estimer et suivre l'état du système cardio-vasculaire.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Dosage des MPE et évaluation de la pression centrale avant et 4h après l’administration de la rosuvastatine ou placebo
    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) 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 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 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 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
    L'étude sera terminée lorsque le dernier pateint inclus sera sortis d'étude.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 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 state80
    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 Decision2013-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-24
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