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    Summary
    EudraCT Number:2017-003903-23
    Sponsor's Protocol Code Number:P150946J
    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:2017-10-13
    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 number2017-003903-23
    A.3Full title of the trial
    Assessment of Beta blocker interruption after uncomplicated mYocardial infarction on Safety and Symptomatic cardiac events requiring hospitalization: The ABYSS Study
    Evaluation de l'arrêt de l'administration de bêta-bloquant après un infarctus du myocarde non compliqué sur l'incidence des évènements cardiaques symptomatiques nécessitant une hospitalisation. Etude ABYSS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of Beta blocker interruption after uncomplicated mYocardial infarction : The ABYSS Study
    A.3.2Name or abbreviated title of the trial where available
    ABYSS
    A.4.1Sponsor's protocol code numberP150946J
    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 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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailelodie.soler@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.2.1.2Country 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
    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
    Myocardial infarction
    Infarctus du myocarde
    E.1.1.1Medical condition in easily understood language
    Patient after uncomplicated myocardial infarction.
    Patient après infarctus du myocarde.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10028596
    E.1.2Term Myocardial infarction
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the non-inferiority of the interruption of BB therapy after an uncomplicated MI after one year or more of follow-up compared to the continuation of BB evaluated by the primary endpoint.
    Démontrer la non-infériorité de l'interruption des BB chez les patients ayant fait un infarctus du myocarde non compliqué. En comparaison avec leur maintien au long cours.
    E.2.2Secondary objectives of the trial
    To demonstrate the non-inferiority of the interruption of BB therapy after an uncomplicated MI after one year or more of follow-up after compared to the continuation of BB evaluated by the secondary endpoints.
    Démontrer la non infériorité de l'interruption du traitement par BB après un infarctus du myocarde sans complication.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female > or= 18 years of age
    2. Current treatment with BB whatever the drug or the dose used
    3. Prior documented acute myocardial infarction 6 months or more before randomisation defined either by:
    - a documented ST elevation MI with ST segment elevation (STEMI) and/or the presence of Q wave (Type I MI)
    - a documented episode of Non ST Elevation MI (NSTEMI) with at least one of the followings:
    i) a documented hypokinetic or akinetic segment on echo or any other imaging technique
    ii) segmental hypoperfusion Thallium or any other imaging technique
    iii) segmental aspect of necrosis on MRI
    4. Patient affiliated to Social Security
    5. Informed consent obtained in writing at enrolment into the study
    1. Homme et Femme d'âge > ou = 18 ans
    2. Patient ayant un traitement par BB quel que soit le médicament ou la dose utilisée
    3. Ayant eu un IDM datant d'au moins 6 mois avant la randomisation et définie soit par :
    - Un IDM avec élévation du segment ST documentée (SCAST+) et / ou la présence d'onde Q (IDM de Type I)
    - Un IDM sans élévation du segment ST (SCAST-Tropo+) documenté avec au moins un des éléments suivants :
    i) une hypokinésie ou une akinésie documenté à l''écho ou toute autre technique d'imagerie
    ii) une hypoperfusion segmentaire à la scintigraphie ou toute autre technique d'imagerie de perfusion
    iii) un aspect de nécrose segmentaire à l'IRM
    4. Patient(e) affilié(e) à un régime de sécurité sociale
    5. Consentement éclairé obtenu par écrit à l'inclusion dans l'étude
    E.4Principal exclusion criteria
    1. Uncontrolled arterial hypertension according to investigator decision
    2. Prior episode of heart failure in the past two years of follow-up and/or low left ventricular ejection fraction <40% requiring the use of BB
    3. New ACS (in the past 6 months) including UA/NSTEMI and STEMI
    4. Persistent angina or ischemia (>10% viable myocardium) requiring the use of BB
    5. Prior episode of ventricular or supraventricular arrhythmia in the past year of follow-up requiring the use of BB
    6. Treatment with other investigational agents or devices (randomisation) within the previous 30 days, or previous enrolment in this trial.
    1. Hypertension artérielle non contrôlée
    2. Episode d'insuffisance cardiaque dans les deux dernières années de suivi et / ou fraction d'éjection ventriculaire < 40% nécessitant l'utilisation de BB
    3. Un nouvel épisode de SCA (au cours des 6 derniers mois) quel qu'il soit
    4. Un angor persistant ou une ischémie résiduelle persistante (> 10 % de myocarde viable) nécessitant l'utilisation de BB
    5. Une arythmie ventriculaire ou supraventriculaire documentée dans la dernière année de suivi nécessitant l'utilisation de BB
    6. Le traitement avec d'autres agents ou des dispositifs expérimentaux dans les 30 jours précédents, ou l'inscription précédente dans cet essai
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study will be evaluated, with one-year minimum follow-up, and will be the composite of Major Adverse Cardiovascular Events (MACE) measured at the longest follow-up including:
    - All-cause death
    - Stroke
    - Myocardial infarction (MI)
    - Hospitalisation for any cardiovascular (CV) reason.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the longest follow-up.
    A la visite de suivi la plus avancée.
    E.5.2Secondary end point(s)
    All individual parameters of MACE
    o All cause death
    o Stroke
    o MI (Classified by type of MI, including Stent Thrombosis)
    o Hospitalisation for any CV reason:
    o Angina, Coronary Angiography or Coronary Revascularization (ACS or not):
    - Urgent coronary revascularisation
    o Recurrent ischemia (with or without revascularisation)
    o Heart Failure
    o Arythmia = Ventricular or Supra-Ventricular Tachycardia
    o Syncope, Conduction disorders or PaceMaker Implantation
    o High Blood Pressure

    Other secondary endpoints:
    o Cardiovascular (CV) death
    o Syncope/dizziness requiring a consultation or a hospitalisation.
    o Invasive procedures (catheterisation, percutaneous coronary intervention (PCI), pace-maker or automatic defibrillator implantation, endoscopy…)
    o Angina control
    o Heart Rate Control (Cardiac Frequency during visit) for the first year only
    o Blood Pressure Control (Blood pressure during visit) for the first year only
    o An Epidose of Heart Failure (consultation or Hospitalisation)
    o The quality of life (QoL) will be evaluated in every patient of the ABYSS trial at baseline, 6 and 12 months after randomisation.

    The composite of :
    o Any Death and MI
    o CV death, MI, and stroke.
    o CV death, MI, and urgent coronary revascularisation.
    o CV death, MI, and recurrent ischemia requiring hospitalisation (with or without revascularisation).
    Mesurés par le critère composite et individuel suivant :

    Les critères individuels du critère primaire de jugement.
    o Mortalité toute cause
    o AVC
    o Infarctus du Myocarde (IDM) (Classifié par type incluant la thrombose de stent)
    o Hospitalisation pour raison Cardiovasculaires (CV)
    o Angor, Coronarographie ou Revascularisation Coronaire (SCA ou non)
    - Revascularisation coronaire urgente
    - Récidive d'ischémie (avec ou sans revascularisation)
    o Insuffisance Cardiaque
    o Arythmie = Tachycardie Ventriculaire ou Supra-Ventriculaire
    o Syncope, trouble de la conduction ou implantation d'un PaceMaker
    o Hypertension artérielle

    Autres critères secondaires:
    o Mortalité CV
    o Syncope / étourdissements nécessitant une consultation ou une hospitalisation.
    o Les procédures invasives (de cathétérisme, intervention coronarienne percutanée, pace-maker ou défibrillateur automatique implantable, endoscopie, ...)
    o Contrôle de l'angine de poitrine
    o Contrôle de fréquence cardiaque (durant la première année)
    o Contrôle de la pression artérielle (durant la première année)
    o Un épisode d'insuffisance Cardiaque (consultation ou hospitalisation)
    o Qualité de vie

    Critère composite associant :
    o Toute mort ou IDM
    o Décès CV, IDM ,et AVC.
    o Décès CV, IDM, et revascularisation coronaire urgente.
    o Décès CV, IDM, et récidive d'ischémie nécessitant une hospitalisation (avec ou sans revascularisation).
    E.5.2.1Timepoint(s) of evaluation of this end point
    M6 and M12
    M6 et M12
    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) 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
    Arrêt des bétabloquants.
    Withdrawal of beta blockers.
    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 concerned26
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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.1.2.1Number of subjects for this age range: 1850
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1850
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-10-13. Yes
    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 state3700
    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)
    The referring physician (cardiologist) will judge the usefulness of a continuation or a stop of the betablocker treatment according to the situation of the patient.
    Le médecin référent (cardiologue) jugera de l'utilité d'une continuation ou d'un arrêt du traitement par bétabloquant selon la situation du patient.
    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 Decision2017-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-02
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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