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    Summary
    EudraCT Number:2021-001534-19
    Sponsor's Protocol Code Number:APHP200015
    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:2021-03-25
    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 number2021-001534-19
    A.3Full title of the trial
    Direct oral Anticoagulants for Prevention of lEft ventRIcular Thrombus after anterior acute myocardial InFarction
    Impact de la prescription d’un traitement anticoagulant oral direct chez les patients pris en charge pour un infarctus du myocarde antérieur pour prévenir la formation d’un thrombus intra ventriculaire gauche
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Direct oral Anticoagulants for Prevention of lEft ventRIcular Thrombus after anterior acute myocardial InFarction
    Impact de la prescription d’un traitement anticoagulant oral direct chez les patients pris en charge pour un infarctus du myocarde antérieur pour prévenir la formation d’un thrombus intra ventriculaire gauche
    A.3.2Name or abbreviated title of the trial where available
    APERITIF
    APERITIF
    A.4.1Sponsor's protocol code numberAPHP200015
    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 SponsorAP-HP/DRCI
    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/DRCI
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDRCI
    B.5.2Functional name of contact pointGUIMFACK AURELIE
    B.5.3 Address:
    B.5.3.1Street Address1 AVENUE CLAUDE VELLEFAUX
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75475
    B.5.3.4CountryFrance
    B.5.4Telephone number+33144 84 17 98
    B.5.5Fax number+33144 84 17 01
    B.5.6E-mailaurelie.guimfack@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 XARELTO 2,5 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRivaroxaban 2,5 mg
    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.3.8INN - Proposed INNRIVAROXABAN
    D.3.9.1CAS number 366789-02-8
    D.3.9.4EV Substance CodeSUB29263
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2,5
    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
    Left ventricular (LV) thrombus after acute myocardial infarction (AMI)
    Thrombus intra ventriculaire gauche (VG) après un infarctus du myocarde (IDM)
    E.1.1.1Medical condition in easily understood language
    Anterior AMI patients
    Patients pris en charge pour un IDM antérieur
    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
    The main objective of this randomized trial is to determine whether, in anterior AMI patients (e.g., large necrosis area), the use of rivaroxaban 2.5mg twice daily in addition to DAPT (dual antiplatelet therapy) will reduce LV thrombus formation, compared with the use of DAPT alone (current practice).
    L'objectif principal est de déterminer si, chez les patients pris en charge pour un IDM antérieur, l'utilisation de rivaroxaban 2,5mg (deux fois par jour) en association avec une double anti agrégation plaquettaire (DAP) permet (ou non) de réduire la formation de thrombus intra VG, par rapport à l’utilisation de la DAP seule (pratique actuelle).
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the efficacy and safety of rivaroxaban 2.5mg twice daily in addition to DAPT in the prevention clinical events compared to DAPT alone.
    Les objectifs secondaires sont d’évaluer l’efficacité et la sécurité du rivaroxaban 2.5mg (2 fois par jour) en association avec la DAP sur la prévention d’évènements cliniques par rapport à la DAP seule.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 years;
    - Anterior STEMI (e.g., ST elevation above the J-point of ≥0.1 millivolt in ≥two contiguous leads or left bundle branch block) or very high-risk NSTEMI (e.g., dynamic ECG changes or ongoing chest pain or acute heart failure or hemodynamic instability independent of ECG changes or life-threatening ventricular arrhythmias) with echographic evidence of anterior wall motion abnormalities and, with a culprit lesion of the proximal or mid portion of the left anterior descending (LAD) on the coronary angiography;
    - No contraindication to CMR (e.g., claustrophobia, pacemaker or defibrillator not compatible);
    - Ability to provide written informed consent and willing to participate in 1-month follow-up period.
    - Affiliation of social security regime.
    - Age ≥ 18 ans,
    - IDM avec sus décalage ST antérieur (élévation du segment ST avec un point J ≥0.1 millivolt dans au moins 2 dérivations du même territoire ou bloc de branche gauche) ou sans sus décalage ST à haut risque (changements dynamiques à l’ECG ou douleur thoracique persistante ou insuffisance cardiaque aigue ou instabilité hémodynamique ou troubles du rythme ventriculaire pouvant mettre en jeu le pronostic vital) avec des troubles de la cinétique segmentaire dans le territoire antérieur à l’échocardiographie, et une lésion coupable de l’inter ventriculaire antérieur (proximal ou moyenne) à la coronarographie,
    - Absence de contre-indication à l’IRM (claustrophobie, pacemaker ou défibrillateur non compatible);
    - Avoir recueilli un consentement éclairé écrit et l’accord pour participer à une période de suivi d'un mois ou d’un an (selon la présence ou non d’un thrombus intra VG).
    - Affiliation au régime de sécurité sociale.
    E.4Principal exclusion criteria
    - Patients with cardiogenic shock (systolic blood pressure <90 mmHg with clinical signs of low output or patients requiring inotropic agents);
    - Patients referred to surgery for coronary artery bypass grafting (CABG) or treatment of acute complications (e.g. ventricular septal rupture);
    - Patients treated with fibrinolytic therapy;
    - LV thrombus diagnosed before randomization using a transthoracic echocardiography;
    - Active major bleeding or major surgery within the last 30 days;High bleeding risk (patients considered at increased risk of bleeding during DAPT; e.g. PRECISE-DAPT score >25; severe liver failure or Child Pugh class C);
    - Known history of intracranial hemorrhagic stroke or intra-cranial aneurysm;
    - Known history of peptic ulcer;
    - Known stroke (any type) within the last 30 days;
    - Known intolerance to aspirin, P2Y12 inhibitors, rivaroxaban and their excipients;
    - According to the SmPC any contraindication to rivaroxaban, aspirin, clopidogrel, ticagrelor, and prasugrel
    - Known intolerance to gadolinium chelates;
    - Chronic kidney disease (creatinine clearance (ClCr) <30 mL/min);
    - Indication for anticoagulation (e.g. atrial fibrillation, mechanical valves, LV thrombus…);
    - Life expectancy <1 month;
    - Known pregnancy at time of randomization or breastfeeding women;
    - Currently participating in another trial
    - Protected adults (including individual under guardianship by court order)
    - Persons deprived of their liberty by judicial or administrative decision
    - Choc cardiogénique (PAS <90 mmHg avec des signes de bas débit ou nécessité d’un traitement inotrope);
    - Patients référés à une chirurgie cardiaque pour pontage aorto-coronarien (PAC) ou pour une complications mécaniques (par exemple rupture septale ventriculaire);
    - Patients traités par fibrinolytiques;
    - Thrombus intra VG diagnostiqué avant la randomisation en échocardiographie;
    - Saignement majeur (ou actif) ou chirurgie majeure au cours des 30 derniers jours;
    - Risque hémorragique élevé (patients considérés comme présentant un risque hémorragique accru; par exemple, un score PRECISE-DAPT> 25);
    - Antécédents connus d'AVC hémorragique ou d'anévrisme intracrânien;
    - AVC connu (de tous types) au cours des 30 derniers jours;
    - Intolérance connue à l'aspirine, aux inhibiteurs de P2Y12, au rivaroxaban;
    - Contre-indication au rivaroxaban, à l'aspirine, au clopidogrel, au ticagrélor et au prasugrel ;
    - Intolérance connue aux chélates de gadolinium;
    - Maladie rénale chronique (clairance de la créatinine (ClCr) <30 mL / min);
    - Indication à un traitement anticoagulant (ex: fibrillation auriculaire, valves mécaniques, thrombus VG…);
    - Espérance de vie <1 mois;
    - Grossesse connue au moment de la randomisation ou des femmes qui allaitent;
    - Participation à un autre essai
    - Adultes protégés (y compris les personnes sous tutelle par décision de justice)
    - Personnes privées de liberté par décision judiciaire ou administrative.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the presence of LV thrombus at 1-month, as detected by the validated delayed enhancement CMR (DE-CMR) method
    Le critère de jugement principal est la présence d’un thrombus intra VG à 1 mois détecté en IRM cardiaque.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1month
    1 mois
    E.5.2Secondary end point(s)
    Secondary end points :
    - LV thrombus dimension (greatest diameter),
    - Rate of bleeding events using the Thrombolysis in Myocardial Infarction (TIMI) and the Bleeding Academic Research Consortium (BARC) criteria at 1 month (investigator-reported),
    - Rate of major adverse cardiac events (MACE) defined as a composite of death, non-fatal MI or stroke at 1 month and at 1-year*,
    - Rate of individual components of the MACE at 1 month and at 1-year*,
    - Survival without MACE and individual component of MACE at 1 month and 1 year.
    - Rate of occurrence of systemic thrombo-embolic event,
    - Rate of coronary revascularization at 1 month and at 1-year*,
    - Rate of stent thrombosis at 1 month and at 1-year*,
    - Rehospitalization for acute heart failure at 1 month and at 1-year*,
    - Rehospitalization in a cardiology department at 1 month and at 1-year*,
    - Antithrombotic drugs used in the patients with confirmed LV thrombus on CMR at one month, between 1 month and 1 year.
    Critères de jugement secondaires :
    - Dimensions du thrombus intra VG (diamètre maximal)
    - Taux de saignements en utilisant les classifications TIMI (Thrombolysis in Myocardial Infarction) et BARC (Bleeding Academic Research Consortium) à 1 mois
    - Taux d’évènements cardiovasculaires majeurs (MACE) définis par un critère composite associant décès, IDM non fatal, ou accident vasculaire cérébral (AVC) à 1 mois,
    - Taux d’évènements individualisés à 1 mois,
    - Taux des évènements thromboemboliques, des revascularisations myocardiques, et des thromboses de stents à 1 mois,
    - Ré hospitalisation pour insuffisance cardiaque aigue à 1 mois,
    - Ré hospitalisation en Cardiologie à 1 mois,
    - Traitements antithrombotiques utilisés chez les patients avec un thrombus intra VG au cours de la première année après inclusion.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 month
    1 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.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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Traitement habituel sans rivaroxaban
    Gold Standard (without rivaroxaban 2.5mg)
    E.8.2.4Number of treatment arms in the trial2
    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 concerned29
    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
    LVLS
    dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    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.1.3Elderly (>=65 years) Information not present in EudraCT
    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 state560
    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 Decision2021-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-04
    P. End of Trial
    P.End of Trial StatusOngoing
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