Colchicine Versus Placebo in Acute Myocarditis Patients

PHASE3RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

July 16, 2024

Primary Completion Date

January 16, 2028

Study Completion Date

July 16, 2028

Conditions
Acute Myocarditis
Interventions
DRUG

Colchicine Pill

"Participant receive, in addition to standard of care therapy, six months of colchicine (at a dose of 0.5 mg twice daily, morning and evening) beginning maximum 72 hours post-randomization. The standard of care is defined according to the European consensus paper as follow: All participants without contraindication receive a betablockers, and heart failure ESC (European Society of Cardiology) guidelines directed medical therapies if LVEF \< 50% (Left Ventricular Ejection Fraction), including ACE (Angiotensin-Converting Enzyme) inhibitors, diuretics if indicated. The choice of the dosage and the drug is left at the investigator decision.~During the six months of the treatment administration, in case of severe adverse reaction (such as nausea and/or diarrhea during five days), a dose reduction could be considered by the investigator: half of the study protocol dose could be accepted (0.5 mg per day in the morning). In case of remaining adverse reactions, the study drug should be stopped."

DRUG

Placebo

"Participant receive, in addition to standard of care therapy, six months of placebo (at a dose of 0.5 mg twice daily, morning and evening) beginning maximum 72 hours post-randomization.~The standard of care is defined according to the European consensus paper as follow: All participants without contraindication receive a betablockers, and heart failure ESC (European Society of Cardiology) guidelines directed medical therapies if LVEF \< 50% (Left Ventricular Ejection Fraction), including ACE (Angiotensin-Converting Enzyme) inhibitors, diuretics if indicated. The choice of the dosage and the drug is left at the investigator decision."

Trial Locations (2)

69029

RECRUITING

Unité de Soins Intensifs Cardiologiques - Hôpital Cardiovasculaire Louis Pradel, Bron

75013

RECRUITING

Institut de Cardiologie - APHP Pitié Salpêtrière, Paris

All Listed Sponsors
collaborator

Hospices Civils de Lyon

OTHER

collaborator

Fonds de Dotation ACTION

OTHER

lead

Assistance Publique - Hôpitaux de Paris

OTHER