Colchicine Versus Placebo in Acute Myocarditis Patients

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

Inclusion Criteria: - Symptom onset of 21 days or less, - Chest pain and/or Heart failure symptoms and/or palpitations - Troponins superior to 99 percentile of reference value, - Myocarditis diagnostic confirmation (by Contrast-Enhanced Cardiac Magnetic Resonance (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 superior to 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 one month after, - Man accepting effective contraception for the duration of treatment and one month after, - Participant with affiliation to the French Health Care System sécurité sociale, - Written informed consent of the patient obtained. Exclusion Criteria: - Cardiogenic shock requiring inotropes or vasopressors (patients with inotropes discontinued for more than 24 hours can be enrolled) - Giant cell myocarditis or eosinophilic myocarditis - Acute coronary syndrome or known coronary stenosis superior to 50% - Toxic cardiomyopathy - Active chronic inflammatory disease, chronic active infection, evolving cancer - A recent severe sepsis (7 days) or all recent acute illness - Hypersensitivity to Investgational Medical Product'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), - Chronic treatment with corticosteroids or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or immunosuppressant. - Sarcoidosis - Severe liver (Child Pugh C) or known renal dysfunction (known Glomerular Filtration Rate (GFR) less or equal to 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 - Major digestive disorders (chronic diarrhea, inflammatory disease of the digestive tract as uncontrolled ulcerative colitis or active Crohn disease) - Immunosuppression, spinal cord aplasia - Hemopathy - Hypereosinophilia more than 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, - Participant 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, - Participant under legal protection: under guardianship (trusteeship or curatorship)

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extent of Late Gadolinium Enhancement (LGE) evaluated on Cardiac Magnetic Resonance (CMR);Composite Clinical primary outcome

Secondary Outcome Measures

Name	Time	Method
Safety of colchicine;Composite clinical secondary outcome;Left ventricular volume on Cardiac Magnetic Resonance (CMR);Left ventricular volume on transthoracic echocardiography (TTE);Relative variation in Extent of late gadolinium enhancement (LGE) and edema;Tissue properties evaluated on Cardiac Magnetic Resonance (CMR);Serum biomarkers;Specific Inflammatory markers;Ventricular premature complex (VPC) evaluated on Holter ElectroCardiogramm (ECG)