BridgeMD
Compares treatment options for Acute Myocarditis
Official title Colchicine Versus Placebo in Acute Myocarditis Patients
ClinicalTrials.gov ID: NCT05855746
What this study is testing
What is Colchicine Pill?
Colchicine Pill is an investigational medicine, given as an once-daily, being studied as a potential treatment for acute myocarditis.
Also referred to as Colchicine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Myocarditis is an inflammatory disease of the heart, mostly caused by viruses. Patients with acute myocarditis are exposed to several complications: recurrence, ventricular arrhythmias (from 5 to 30%), heart failure (5-10%), death or heart transplantation (\< 4%).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Symptom onset of 28 days or less,
- Myocarditis initially presenting with chest pain and/or Heart failure symptoms and/or palpitations
- Troponins superior to 99 percentile of reference value, at any time between admission 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 computed tomography angiography for patients with age superior to...
You likely can't join if
- 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)
See the full eligibility criteria
- Symptom onset of 28 days or less,
- Myocarditis initially presenting with chest pain and/or Heart failure symptoms and/or palpitations
- Troponins superior to 99 percentile of reference value, at any time between admission 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 computed tomography angiography for patients with age superior to 40-year-old with one or more cardiovascular risk factor (hypertension...
- 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.
- 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...
- 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...
- 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 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 between admission and inclusion (within 7 days)
- 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 between admission and inclusion
- 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 treatment trial, within 30 days before randomization,
- Participant under treatment having an interaction with colchicine [macrolides (telithromycin, azithromycin, clarithromycin, dirithromycin, erythromycin, josamycin, midecamycin, roxithromycin), pristinamycin...
- Participant under legal protection: under guardianship (trusteeship or curatorship)
The study team makes the final eligibility decision.
Where it's taking place
- Bron, France
- Paris, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bron, France; Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.