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    Summary
    EudraCT Number:2022-002563-29
    Sponsor's Protocol Code Number:APHP211429
    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:2023-01-24
    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 number2022-002563-29
    A.3Full title of the trial
    Colchicine versus Placebo in Acute Myocarditis Patients to Reduce Late Gadolinium Enhancement Mass on Cardiac Magnetic Resonance and the risk of Clinical Outcomes: The ARGO tria
    NA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    NA
    A.3.2Name or abbreviated title of the trial where available
    ARGO
    ARGO
    A.4.1Sponsor's protocol code numberAPHP211429
    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 – Hôpitaux 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 supportMinistère de la Santé, PHRC national, 2020
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPHP
    B.5.2Functional name of contact pointSEYMOUR-INAMO
    B.5.3 Address:
    B.5.3.1Street Address1 Avenue Claude VELLEFAUX
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number+3301 44 84 17 42
    B.5.5Fax number+3301 44 84 17 01
    B.5.6E-mailkarine.seymour@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 COLCHICINE OPOCALCIUM 1 mg, comprimé sécable
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires Mayoly Spindler
    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 Tablet
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    NA
    NA
    E.1.1.1Medical condition in easily understood language
    Myocarditis
    NA
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study will be to assess in patients presenting with acute myocarditis the efficacy of a 6 months treatment with colchicine versus placebo on the inflammatory myocardial damage evaluated by Late Gadolinium Enhancement (LGE) (% of LV mass) on CMR or on clinical outcome assessed on the rate of rehospitalization for heart Failure or acute myocarditis recurrence; or clinically relevant recurrent chest pain (defined as leading to an unplanned/urgent consultation or hospitalization); or sustained ventricular arrhythmias; or left ventricular assistance; or heart transplantation; or cardiovascular death at 6 months.
    NA
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety of colchicine in acute myocarditis during 6 months:
    2. To evaluate the efficacy of colchicine on secondary efficacy endpoints, including:
    a/ Each component of the composite clinical endpoint at 6 months and one year:
    - Occurrence of heart failure or acute myocarditis recurrence;
    - Occurrence of clinically relevant recurrent chest pain (defined as leading to an unplanned/urgent consultation or hospitalization)
    - Occurrence of sustained ventricular arrhythmias,
    - Occurrence of left ventricular assistance
    - Occurrence of heart transplantation,
    - Occurrence of cardiovascular death
    b/ The LVEF, LV end-diastolic and end-systolic volumes, determined by a follow-up CMR at 6 months determined centrally by the Corelab,
    c/ The relative variation in LVEF, LV end-diastolic and end-systolic volumes, determined by a follow-up transthoracic echocardiography at 6 months ....



    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥ 18 years and < 65 years old,
    • Symptom onset ≤ 21 days,
    • Chest pain and/or Heart failure symptoms and/or palpitations
    • Troponins > 99 percentile of reference value,
    • Myocarditis diagnostic confirmation (by CMR, according to the Lake Louise criteria with the presence of myocardial damage,
    • No evidence for ischemic heart disease on coronary angiography or coronary computed tomography angiography for patients with age > 40-year-old with one or more cardiovascular risk factor (hypertension, smoking, hypercholesterolemia, diabetes, personal or family history of coronary artery disease),
    • Woman of child-bearing age with an effective contraception method according to the investigator for the duration of treatment and 1 month after,
    • Man accepting effective contraception for the duration of treatment and 1 month after,
    • Patients with affiliation to the French Health Care System “sécurité sociale”,
    • Written informed consent of the patient obtained.
    NA
    E.4Principal exclusion criteria
    NA
    - Cardiogenic shock requiring inotropes or vasopressors (patients with inotropes or vasopressors discontinued for >24h can be enrolled)
    - Giant cell myocarditis or eosinophilic myocarditis
    - Acute coronary syndrome or known coronary stenosis > 50%
    - Toxic cardiomyopathy
    - Active cancer
    - Hypersensitivity to IMP’s active substances (colchicine) or to any of the excipients (including lactose, sucrose, microcrystalline cellulose, colloidal silica, magnesium stearate colourants: E127, Dual Red 40)
    - Any known contra-indication to CMR or associated contract products (claustrophobia, pace maker, defibrillator, history of hypersensitivity to gadoteric acid or to gadolinium contrast agents or to meglumine),
    - Indication for a treatment with corticoids,
    - Sarcoidosis,
    - Severe liver (Child Pugh C) or known renal dysfunction (known GFR < 30 ml/min according Cockroft),
    - Cytopenia : hemoglobin less than 100 grams/L, white blood cell count less than 3.0 G/L, platelet count less than 100 G/L
    - Hemopathy
    - Hypereosinophilia > 0.5 G/L
    - Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive local laboratory test
    - Administration of any investigational drug or participation in another interventional trial, within 30 days before randomization.
    - Patient under treatment having an interaction with colchicine [macrolides (telithromycin, azithromycin, clarithromycin, dirithromycin, erythromycin, josamycin, midecamycin, roxithromycin), pristinamycin, cyclosporine, verapamil, all protease inhibitors, telaprevir, CYP3A4 powerful inhibitors, azole antifungals, vitamin K antagonists],
    - Patients under legal protection: under guardianship (trusteeship or curatorship),
    E.5 End points
    E.5.1Primary end point(s)
    NA
    The endpoint will be a co-primary endpoint:
    - Extent of late gadolinium enhancement (% of left ventricle mass) evaluated on CMR at 6 months.
    or
    - Clinical outcome assessed on the rate of rehospitalization for heart Failure or acute myocarditis recurrence; or clinically relevant recurrent chest pain (defined as leading to an unplanned/urgent consultation or hospitalization); or sustained ventricular arrhythmias; or left ventricular assistance; or heart transplantation; or cardiovascular death during the study period at 6 months.
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    NA
    E.5.2Secondary end point(s)
    1. Le pourcentage de changement de l’osmolalité urinaire entre baseline (avant le traitement) et à 6 et 12 mois.
    2. Nombre moyen de mictions nocturnes déclaré par le patient avant le traitement et à 2, 6 et 12 mois.
    3. Score des échelles d'intensité de la soif et de détresse avant le traitement et à 2, 6 et 12 mois.
    4. Présence d'une polyurie (définie comme un débit urinaire quotidien > 3 L/jour) après 2, 6 et 12 mois de traitement.
    5. Score de l'échelle de qualité de vie (SF36) avant le traitement et à 2, 6 et 12 mois.
    6. eDFG (estimé par l'équation CKD-EPI basée sur la mesure de la créatinine sérique standardisée) avant le traitement et à 2, 6 et 12 mois.
    7.a Scores de l'échelle d'humeur (YMRS et MADRS), score de l'échelle d'anxiété (GAD7) et score du sommeil de Pittsburgh (PSQI) avant le traitement et à 2, 6 et 12 mois.
    7.b Nombre total d'admissions à l'hôpital pour rechute maniaque ou dépressive pendant les 12 mois de traitement.
    8. Différence des niveaux résiduels de lithium plasmatique avant et après la période de traitement de 2 mois.
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    - CMR at 6 months
    - Composite clinical endpoint at 6 months and 1 year
    NA
    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 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 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) No
    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 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 concerned12
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 300
    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 No
    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 2023-01-24. 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 state300
    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
    Non
    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 Decision2023-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-27
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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