Colchicine Versus Placebo in Acute Myocarditis Patients

Inclusion Criteria:

• Symptom onset of 28 days or less,

• Myocarditis initially presenting with chest pain and/or Heart failure symptomsand/or palpitations

• Troponins superior to 99 percentile of reference value, at any time betweenadmission and inclusion

• Myocarditis diagnostic confirmation (by Contrast-Enhanced Cardiac Magnetic Resonance (CMR), according to the Lake Louise criteria (2009 or later),

• No evidence for ischemic heart disease on coronary angiography or coronary computedtomography angiography for patients with age superior to 40-year-old with one ormore 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 theinvestigator for the duration of treatment and one month after,

• Man accepting effective contraception for the duration of treatment and one monthafter,

• 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 inotropesdiscontinued 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)

• 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;intra-ocular metal foreign bodies, clips such as cerebral, carotid, or aorticaneurysm, cochlear implants, any implant held in by magnet, history ofhypersensitivity to gadoteric acid or to gadolinium contrast agents or tomeglumine). Patients with an implantable cardioverter-defibrillator (ICD) orpacemaker (PM) are also excluded due to the risk of imaging artifacts, which maycompromise the reliable quantification of late gadolinium enhancement (LGE).

• Chronic treatment with corticosteroids or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or high-dose aspirin or immunosuppressant.

• Sarcoidosis

• Severe liver (Child Pugh C) or known renal dysfunction (known Glomerular FiltrationRate (GFR) less or equal to 30 ml/min according Cockroft),

• Cytopenia : hemoglobin less than 100 grams/L, white blood cell count less than 3.0G/L, platelet count less than 100 G/L between admission and inclusion (within 7days)

• Major digestive disorders (chronic diarrhea, inflammatory disease of the digestivetract as uncontrolled ulcerative colitis or active Crohn disease)

• Immunosuppression, spinal cord aplasia

• Hemopathy

• Hypereosinophilia more than 0.5 G/L between admission and inclusion

• Pregnant or nursing women, where pregnancy is defined as the state of a female afterconception and until the termination of gestation, confirmed by a positive locallaboratory test,

• Administration of any investigational drug or participation in anotherinterventional 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, allprotease inhibitors, telaprevir, CYP3A4 powerful inhibitors, azole antifungals,vitamin K antagonists]

• Participant under legal protection: under guardianship (trusteeship or curatorship)