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ARAMIS

Evaluation of Anakinra versus placebo in treatment of acute myocarditis and evaluation of the contuity of the reference treatment with IEC in patients without ventricular dysfunction

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objectif

Evaluation of Anakinra versus placebo in treatment of acute myocarditis and evaluation of the contuity of the reference treatment with IEC in patients without ventricular dysfunction ventriculaire.

date de réalisation

2017

nombre de patients

119

nombre de centres participants

6 french Centers

type de financement

Public (PHRC 2015)

Référence

NCT03018834

Anakinra Versus Placebo for the Treatment of Acute MyocarditIS (ARAMIS)

Study Description

There is no specific treatment of acute myocarditis, especially during the inflammatory period. Interleukin (IL) is specifically involved during this period and play a role in myocardial oedema. ANAKINRA, an IL-1β Blocker, is a new treatment that has never been evaluated in myocarditis. The benefit for the patient could be important with a reduction of heart failure and ventricular arrhythmias.
ARAMIS is a Double Blind Randomized clinical trial Phase IIb of superiority, enrolling two groups: one group treated with the standard of care, defined as the maximum tolerated dosage of any beta blockers and ACE, and placebo versus ANAKINRA in addition to the standard of care in patients treated for an acute Myocarditis. Patients will be randomized to receive ANAKINRA 100 mg/daily or placebo subcutaneously once a day until hospital discharge, for a maximum of 14 days, in addition to standard care: ACE and Beta-blocker for 6 months. Randomization 1:1 will be conducted centrally using the electronic Case Report Form (eCRF).
As an exploratory analysis, a second randomization for ACE discontinuation in patients without left ventricular dysfunction (LVEF › 50%) at one month post discharge will be performed. One group will stopped the treatment at one month and the second group will continued the ACE for 6 months. This second randomization is in open label.

source clinicaltrials.gov

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