Colchicine Versus Placebo in Acute Myocarditis Patients
Recruiting
Phase 3
Interventional Study
Acute Myocarditis
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 300 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
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%). To date, there is no specific treatment for myocarditis. Patient management only focuses upon empirical optimal care of arrhythmia and …
Trial Locations
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Eligibility Criteria
Inclusion 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 (b…
Contacts