Colchicine Versus Placebo in Acute Myocarditis Patients

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · May 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of colchicine, a medication known for its anti-inflammatory properties, on patients with acute myocarditis, which is an inflammation of the heart often caused by viruses. The goal is to see if colchicine can improve heart function and reduce complications like heart failure and irregular heartbeats. Currently, there is no specific treatment for myocarditis, so this trial is important as it explores a potential option for managing this condition.

To participate in this trial, patients should have experienced symptoms of myocarditis, such as chest pain or heart failure, within the last 21 days, and have certain lab results that confirm the diagnosis. They also need to not have other serious heart conditions or certain health issues like severe liver or kidney problems. If eligible, participants will receive either colchicine or a placebo (a non-active treatment) and will be closely monitored throughout the study. This trial aims to provide valuable insights into how colchicine might help patients with this challenging heart condition.

Gender

ALL

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 (2009 or later),
• • 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)
• • 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 aortic aneurysm, cochlear implants, any implant held in by magnet, non-MR compatible cardiac devices (pace maker or 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 \[macrolides (telithromycin, azithromycin, clarithromycin, dirithromycin, erythromycin, josamycin, midecamycin, roxithromycin), pristinamycin,, cyclosporine, verapamil, all protease inhibitors, telaprevir, CYP3A4 powerful inhibitors, azole antifungals, vitamin K antagonists\]
• • Participant under legal protection: under guardianship (trusteeship or curatorship)