Anakinra versus placebo double blind Randomized controlled trial for the treatment of Acute MyocarditIS

Anakinra versus placebo double blind Randomized controlled trial for the treatment of Acute Myocarditis - ARAMIS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003433-20-FR

Enrollment

120

Registered

2016-11-04

Start date

2016-12-16

Completion date

Unknown

Last updated

2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients hospitalized for Acute myocarditis MedDRA version: 19.0 Level: LLT Classification code 10000932 Term: Acute myocarditis System Organ Class: 100000004849

Interventions

Trade Name: kineret Product Name: kineret Pharmaceutical Form: Solution for injection INN or Proposed INN: ANAKINRA CAS Number: 143090-92-0 Concentration unit: mg milligram(s) Concentration type: equa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients hospitalized for Acute myocarditis defined as: -Chest Pain (or modification of the ECG) AND Troponin Rise (*1.5 Normal range) AND Myocarditis proven by RMI in the first 72h after admission - Age > 18 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Active coronary disease -Clinical Suspicion or proven underlying disease: systemic lupus, antiphospholipid antibodies, Lyme disease, trypanosomiase disease, myositis, signs of sarcoidosis, giant cell myocarditis, chronic inflammatory disease, tuberculosis, HIV, HBV or HCV infection -Latex allergy -Pregnancy, breastfeeding -Contra-indication to ANAKINRA (known hypersensitivity to the active substance or to any of the excipients, -neutropenia < 1,5.109/L) -Renal failure, CrCl < 30 ml/min (MDRD) -Asthma -Malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study -History of malignancy -Non Steroidian Anti Inflammatory drug within the past 14 days -Anti TNF within the past 14 days -No affiliation to the French Health Care System "sécurité sociale" -Hepatic impairement = Child-Pugh Class C -Mechanical ventilation -Circulatory assistance.

Design outcomes

Primary

Measure	Time frame
Main Objective: to assess the efficacy of ANAKINRA in Acute Myocarditis compared to placebo in addition to standard therapy. ;Secondary Objective: -To assess the cost-effectiveness of ANAKINRA in the setting of acute myocarditis -To assess the effect of ACE discontinuation in patient with preserved LVEF -To determine if ANAKINRA improves NT proBNP fall - To determine if ANAKINRA improves troponin fall -To determine if ANAKINRA improves the rate of sustained or not sustained ventricular tachycardia, Heart Failure, or Cardiac Death ;Primary end point(s): number of days alive free of any myocarditis complications defined as ventricular arrhythmias, heart failure, chest pain, ventricular dysfunction defined as LVEF<50%, within 28 days post hospitalization;Timepoint(s) of evaluation of this end point: 4YERS	—

Measure

Time frame

Main Objective: to assess the efficacy of ANAKINRA in Acute Myocarditis compared to placebo in addition to standard therapy. ;Secondary Objective: -To assess the cost-effectiveness of ANAKINRA in the setting of acute myocarditis -To assess the effect of ACE discontinuation in patient with preserved LVEF -To determine if ANAKINRA improves NT proBNP fall - To determine if ANAKINRA improves troponin fall -To determine if ANAKINRA improves the rate of sustained or not sustained ventricular tachycardia, Heart Failure, or Cardiac Death ;Primary end point(s): number of days alive free of any myocarditis complications defined as ventricular arrhythmias, heart failure, chest pain, ventricular dysfunction defined as LVEF<50%, within 28 days post hospitalization;Timepoint(s) of evaluation of this end point: 4YERS

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Secondary

Measure	Time frame
Secondary end point(s): -Total cost, total QALYs, incremental cost effectiveness and cost utility ratios -LVFE at 6 month and one year assessed by cardiac MRI and TTE -All cause of death rate during the 12 months follow-up -Cardiovascular death at 12 months -Heart Failure at 12 months -Ventricular tachycardia during the 12 months follow-up -NT-proBNP above 450 pg/mL (in patients aged below 50); above 900 pg/mL (age 50-75 years), or above 1800 pg/mL (patients older than 75) -50% decrease of the troponin level at discharge compared to admission ;Timepoint(s) of evaluation of this end point: 4 yers	—

Measure

Time frame

Secondary end point(s): -Total cost, total QALYs, incremental cost effectiveness and cost utility ratios -LVFE at 6 month and one year assessed by cardiac MRI and TTE -All cause of death rate during the 12 months follow-up -Cardiovascular death at 12 months -Heart Failure at 12 months -Ventricular tachycardia during the 12 months follow-up -NT-proBNP above 450 pg/mL (in patients aged below 50); above 900 pg/mL (age 50-75 years), or above 1800 pg/mL (patients older than 75) -50% decrease of the troponin level at discharge compared to admission ;Timepoint(s) of evaluation of this end point: 4 yers

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Countries

France

Contacts

Public ContactDRCD Hôpital St Louis

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

fadila.amerali@aphp.fr

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026