Colchicine Versus Placebo in Acute Myocarditis Patients (ARGO)
Acute Myocarditis
About this trial
This is an interventional treatment trial for Acute Myocarditis focused on measuring Myocarditis, Inflammation, Colchicine
Eligibility 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)
Sites / Locations
- Unité de Soins Intensifs Cardiologiques - Hôpital Cardiovasculaire Louis Pradel
- Institut de Cardiologie - APHP Pitié Salpêtrière
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Colchicine
Placebo
Participant receive in addition to standard of care therapy, six months of Colchicine
Participant receive in addition to standard of care therapy, six months of placebo