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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:2007-004901-91
    Sponsor's Protocol Code Number:P070117
    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:2007-11-29
    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 number2007-004901-91
    A.3Full title of the trial
    Exploration de l'influence du polymorphisme *2 du gène codant pour le cytochrome 2C19 sur la réponse au clopidogrel chez le jeune coronarien
    A.3.2Name or abbreviated title of the trial where available
    CLOVIS 2
    A.4.1Sponsor's protocol code numberP070117
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 Plavix 75 mg
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pharma Bristol-Myers Squibb SNC
    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 namePlavix 75 mg
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClopidogrel
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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
    Les patients inclus dans cette étude seront issus de la cohorte AFIJI (Architecture de la FIbrine chez les Jeunes coronariens Ischémiques)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10011099
    E.1.2Term Coronary disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer le rôle du variant génétique CYP2C19*2 sur la pharmacodynamique (réponse biologique par agrégométrie optique) et la pharmacocinétique du clopidogrel et de ses deux principaux métabolites après administration d'une dose de recharge de clopidogrel 300 mg ou 900 mg chez des patients coronariens.
    E.2.2Secondary objectives of the trial
    Evaluer le rôle du variant génétique CYP2C19*2 sur la réponse pharmacodynamique à l'état basal chez les patients traités chroniquement par clopidogrel 75 mg/jour
    Evaluer une différence de réponse entre les sujets hétérozygotes mutés et les sujets homozygotes mutés.
    Modéliser la relation pharmacocinétique - pharmacodynamique du clopidogrel
    Evaluer la nécessité d'un ajustement posologique chez les sujets porteurs du variant CYP2C19*2.
    Comparaison de l'effet de la dose de charge 300mg vs 900mg sur l'ensemble de la population indépendamment du génotype
    Comparaison de l'effet de la dose de charge 300 mg vs 900 mg sur l'IAP (en agrégométrie optique standard) et sur le VerifyNow en PRU post-traitement
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age > 18 ans
    - Sexe masculin uniquement (95% des patients sont des hommes dans la cohorte AFIJI)
    - Patient du programme AFIJI ayant présenté un syndrome coronarien aigu avec ou sans sus-décalage du segment ST et recevant un traitement journalier anti-agrégant plaquettaire (l'aspirine 75mg à 160 mg/jour ± clopidogrel 75mg/jour) depuis au moins 3 mois.
    - Ne présentant pas d'augmentation du risque hémorragique
    - N'ayant pas présenté de déstabilisation récente (< 3 mois) de sa maladie coronaire
    - Patient informé et ayant donné son consentement écrit pour la participation à l'étude
    - Génotype CYP2C19 : *1/*1, *1/*2 ou *2/*2
    - Génotype P2Y12 : H1/H1 ou H1/H2
    E.4Principal exclusion criteria
    - Sexe féminin
    - Patient ayant développé une contre-indication au clopidogrel :
    1. Hypersensibilité connue à la substance ou à l'un de ses excipients
    2. Insuffisance hépatique sévère
    3. Lésion hémorragique évolutive
    4. Femme enceinte ou allaitant
    - Patient ayant reçu une dose de charge de clopidogrel (>= 300 mg) dans les 7 jours précédents
    - Patient traité avant l'administration de clopidogrel par traitement anti-GP2B/3A et par ticlopidine
    - Non compliance avouée ou suspectée au traitement par clopidogrel lors de l'interrogatoire clinique
    - Refus de signature de la feuille de consentement
    - Génotype P2Y12 : H2/H2.
    - Patient traité au long cours par des médicaments modifiant l'activation plaquettaire (anti-inflammatoires non stéroïdiens, persantine, inhibiteurs des récepteurs à la sérotonine)
    - Patient traité par un médicament interférant avec le cytochrome 2C19
    - Non affiliation à un régime de sécurité sociale.
    - Patient participant à une autre étude randomisée.
    E.5 End points
    E.5.1Primary end point(s)
    Critère d'évaluation principal :
    Le critère d'évaluation principal est l'agrégation plaquettaire induite par l'ADP (voie bloquée par le clopidogrel) mesurée par agrégométrie optique sur plasma riche en plaquette. Le paramètre mesuré sera exprimé sous la forme d'un pourcentage d'inhibition de l'agrégation plaquettaire (IAP) induite par l'ADP ainsi défini : IAP = (AM à H0-AM à H6)/(AM à H0), AM désignant l'agrégation plaquettaire maximale.

    Parallèlement sera mesuré le CPU (valeur absolue d'agrégation post traitement) et le % d'inhibition d'agrégation plaquettaire sera également calculé à l'aide du système VerifyNow™ (Accumetrics® San Diego). Il s'agit d'un bedside test qui évalue spécifiquement la voie du P2Y12. La valeur absolue de PRU post-traitement sera mesurée avec cette technologie ultrarapide qui se fait en sang total et sera comparée avec l'IAP obtenue en agrégométrie optique classique


    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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
    deux doses de charge seront comparées
    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 Information not present in EudraCT
    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
    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
    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.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state180
    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 Decision2007-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-25
    P. End of Trial
    P.End of Trial StatusOngoing
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