Recruiting

ARGOColchicine Versus Placebo in Acute Myocarditis Patients to Reduce Late Gadolinium Enhancement Mass on Cardiac Magnetic Resonance and the Risk of Clinical Outcomes: The ARGO Trial

What is being tested

Colchicine Pill

+ Placebo

Drug

Who is being recruted

Cardiovascular Diseases+4

+ Heart Diseases

+ Inflammation

From 18 to 65 Years

+29 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 3

Interventional

Study Start: July 2024

See protocol details

Summary

Principal SponsorAssistance Publique - Hôpitaux de Paris

Study ContactThomas BOCHATONMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 16, 2024

Actual date on which the first participant was enrolled.

This study is a prospective, randomized, multicenter, double blind, controlled versus placebo, phase III study in which two groups of participants are compared: a group treated with the experimental treatment Colchicine (in addition to standard of care therapy) compared to a control group that receive the corresponding placebo (in addition to standard of care therapy). The inclusion visit takes place during the initial hospitalization stay. The study is presented to all patients presenting with acute myocarditis symptoms and inclusion criteria, hospitalized in participating centers. Once eligible participants have been informed and signed their informed consent, they are randomized (1:1) by a centralized web system (IWRS) in the experimental group (Colchicine) or the control group (Placebo). Participants receive then a numbered box with three months' treatment of Colchicine or placebo. The treatment must start at least within 72h after randomization. Another dispensing is performed during the three months' follow-up visit. All randomized participants are followed during six months after the end of the treatment.

Official TitleColchicine Versus Placebo in Acute Myocarditis Patients to Reduce Late Gadolinium Enhancement Mass on Cardiac Magnetic Resonance and the Risk of Clinical Outcomes: The ARGO Trial

NCT05855746

Principal SponsorAssistance Publique - Hôpitaux de Paris

Study ContactThomas BOCHATONMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesInflammationCardiomyopathiesMyocarditisPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

9 inclusion criteria required to participate

Symptom onset of 21 days or less,

Chest pain and/or Heart failure symptoms and/or palpitations

Troponins superior to 99 percentile of reference value,

Myocarditis diagnostic confirmation (by Contrast-Enhanced Cardiac Magnetic Resonance (CMR), according to the Lake Louise criteria (2009 or later),

Show More Criteria

20 exclusion criteria prevent from participating

Cardiogenic shock requiring inotropes or vasopressors (patients with inotropes discontinued for more than 24 hours can be enrolled)

Giant cell myocarditis or eosinophilic myocarditis

Acute coronary syndrome or known coronary stenosis superior to 50%

Toxic cardiomyopathy

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Participant receive in addition to standard of care therapy, six months of Colchicine

Group II

Placebo

Participant receive in addition to standard of care therapy, six months of placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Unité de Soins Intensifs Cardiologiques - Hôpital Cardiovasculaire Louis Pradel

Bron, FranceOpen Unité de Soins Intensifs Cardiologiques - Hôpital Cardiovasculaire Louis Pradel in Google Maps

Recruiting

Institut de Cardiologie - APHP Pitié Salpêtrière

Paris, France

Recruiting

2 Study Centers