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    Summary
    EudraCT Number:2020-000968-30
    Sponsor's Protocol Code Number:RC31/19/0509
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-03-02
    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 number2020-000968-30
    A.3Full title of the trial
    ASPirin in Immune thRombocytopenia patients with cardiovascular disEase
    Efficacité de l’aspirine chez les patients atteints de purpura thrombopénique immunologique en prévention de maladie cardiovasculaire
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ASPirin in Immune thRombocytopenia patients
    Efficacité de l’aspirine chez les patients atteints de purpura thrombopénique immunologique
    A.3.2Name or abbreviated title of the trial where available
    ASPIRE
    ASPIRE
    A.4.1Sponsor's protocol code numberRC31/19/0509
    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 Toulouse
    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 Toulouse
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Toulouse
    B.5.2Functional name of contact pointCLINICAL RESEARCH ASSISTANT
    B.5.3 Address:
    B.5.3.1Street AddressHôtel-Dieu 2 rue Viguerie TSA 80035
    B.5.3.2Town/ cityTOULOUSE
    B.5.3.3Post code31059
    B.5.3.4CountryFrance
    B.5.4Telephone number561778490+33
    B.5.5Fax number561778411+33
    B.5.6E-maildaguzan.c@chu-toulouse.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 Kardégic
    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 nameacide acétylsalicylique
    D.3.4Pharmaceutical form Oral solution in sachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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) 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
    Immune thrombocytopenia with cardiovascular disease
    Purpura thrombopénique immunologique en prévention de maladie cardiovasculaire
    E.1.1.1Medical condition in easily understood language
    Immune thrombocytopenia
    Purpura thrombopénique immunologique
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10083842
    E.1.2Term Immune thrombocytopenia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the residual platelet function after 75 mg aspirin intake (H24)
    Mesurer l’effet résiduel juste avant la prise quotidienne de l’AAS (soit 24 heures après la dernière prise) sur l’activité de COX par des plaquettes de patients atteints de PTI ayant un turn-over accéléré des plaquettes sanguines et ayant une indication à un traitement par AAS en prévention cardiovasculaire.
    E.2.2Secondary objectives of the trial
    To assess the kinetics of platelet function after daily 75 mg aspirin intake and the relation with arterial thrombosis.
    Évaluer la cinétique de la fonction plaquettaire après une prise quotidienne d'aspirine de 75 mg et sa relation avec la thrombose artérielle
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    adult patients (sup 18-year-old); non-treated ITP or ITP with stable treatment (at least 1 month); treated with aspirin daily for a cardiovascular disease; stable platelet count < 100 x 109/L; at least one month following an arterial thrombosis; no other antiplatelet drug and anticoagulant; affiliated or benefiting from public health insurance.
    Patients :
    - Adultes ( 18 ans)
    - Ayant un PTI selon les critères diagnostiques internationaux
    - Avec une numération plaquettaire < 100 G/L (définissant un PTI actif) stable depuis au moins un mois (au moins deux numérations < 100 G/L espacées d’au moins un mois nécessaires)
    - Sans traitement du PTI ou avec un traitement du PTI stable depuis au moins un mois
    - Traités par AAS 75 mg/jour en prévention cardiovasculaire selon les recommandations en vigueur
    - A distance (au moins un mois) d’un évènement thrombotique artériel
    - Sans traitement antiagrégant autre que l’AAS et sans anticoagulant
    - Consentement libre, éclairé et écrit signé par le participant et l’investigateur (au plus tard le jour de l’inclusion et avant tout examen nécessité par la recherche).
    - Affilié ou bénéficiaire d’un régime de sécurité sociale.
    E.4Principal exclusion criteria
    opposition to participate; modification of ITP treatment, NSAID, serotonin reuptake inhibitor, antiplatelet or anticoagulant drug initiation during the study period; platelet count 100 x 109/L at visit 1 or 2; CRP>10 mg/L at visit 1 or 2, adults under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision. Pregnancy or breastfeeding.
    - Refus de participation
    - Patient sous tutelle ou curatelle, personnes placées sous sauvegarde de justice
    - Patiente enceinte ou allaitante
    E.5 End points
    E.5.1Primary end point(s)
    Platelet production of thromboxane B2 (TXB2) 24 hours after a 75 mg aspirin intake
    Mesure de la synthèse de thromboxane B2 (TXB2) plaquettaire après stimulation par l’acide arachidonique sur un prélèvement obtenu juste avant la prise quotidienne de 75 mg d’AAS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 weeks, 4 weeks and 6 weeks
    2 semaines, 4 semaines et 6 semaines
    E.5.2Secondary end point(s)
    Platelet function by light transmission agregometry (LTA) 24 four hours after a 75 mg aspirin intake; platelet production of TXB2 by lipidomic and platelet function by LTA at H2 and H12 after a75 mg aspirin intake; arterial thromboses identified in the CARMEN registry.
    1. Mesure de l’agrégation plaquettaire en mode optique sur un prélèvement plaquettaire résiduel (juste avant une prise quotidienne de 75 mg d’AAS).
    2. Mesure de la synthèse de TXB2 plaquettaire après stimulation plaquettaire par l’acide arachidonique à H2 et H12 d’une prise de 75 mg d’AAS. Le 12-HETE produit par la lypooxygenase et quantifié dans le même profil de spectrométrie de masse que le TXB2 sera également pris en compte.
    3. Mesure de l’agrégation des plaquettes en mode optique sur un prélèvement plaquettaire à H2 et H12 d’une prise de 75 mg d’AAS.
    4. Détection des évènements thrombotiques artériels colligés dans le registre CARMEN.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 weeks, 4 weeks and 6 weeks
    2 semaines, 4 semaines et 6 semaines
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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
    LPLV
    Dernière visite du dernier patient
    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 months25
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months25
    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: 10
    F.1.3Elderly (>=65 years) No
    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 state10
    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 Decision2021-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-06
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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