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Corticoid Therapy in Acute Myocarditis

NCT06522100 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2024-07-29

No results posted yet for this study

Summary

Refer to the "Detailed Description" section.

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).

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2028-08-16
Completion
2028-08-16

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06522100 on ClinicalTrials.gov