Corticoid Therapy in Acute Myocarditis

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

420

Participants

Timeline

Start Date

February 1, 2025

Primary Completion Date

August 16, 2028

Study Completion Date

August 16, 2028

Conditions
Acute Myocarditis
Interventions
DRUG

Intravenous administration of Methylprednisolone

Patients will take intravenous administration of Methylprednisolone (500mg/100ml by IV over 30 minutes per day) for 3 days.

DRUG

Oral Prednisone

After intravenous administration of Methylprednisolone patients will take by oral Prednisone 1mg/kg per day once a day (with a maximum dose of 90 mg per day for patients weighing \> 90kg) for 1 month, followed with a progressive decrease of 10 mg Prednisone every 15 days until a dose of 10mg per day during 15 days (= stop).

DRUG

Perfusion of placebo

Patients will take perfusion of placebo (G5%: 100ml over 30 minutes per day) for 3 days.

DRUG

Oral Prednisone placebo

After the perfusion of placebo, patients will take by oral Prednisone placebo once a day for the same duration as that required if the patient was in the investigational medicinal products group (1 month + progressive decrease).

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER