Acute MyocarditisPhase 3ARGONCT05855746
Colchicine Versus Placebo in Acute Myocarditis Patients
A Phase 3 study testing Colchicine Pill in people with Acute Myocarditis, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Myocarditis is an inflammatory disease of the heart, mostly caused by viruses. Patients with acute myocarditis are exposed to several complications: recurrence, ventricular arrhythmias (from 5 to 30%), heart failure (5-10%), death or heart transplantation (< 4%). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myocarditis
- What is being tested?
- Colchicine Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Jul 2024to 16 Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptom onset of 28 days or less,
- Myocarditis initially presenting with chest pain and/or Heart failure symptoms and/or palpitations
- Troponins superior to 99 percentile of reference value, at any time between admission and inclusion
- Myocarditis diagnostic confirmation (by Contrast-Enhanced Cardiac Magnetic Resonance (CMR), according to the Lake Louise criteria (2009 or later),
- No evidence for ischemic heart disease on coronary angiography or coronary computed tomography angiography for patients with age superior to 40-year-old with one or more cardiovascular risk factor (hypertension, smoking, hypercholesterolemia, diabetes, personal or family history of coronary artery disease),
- Woman of child-bearing age with an effective contraception method according to the investigator for the duration of treatment and one month after,
Show all 9Show fewer
- Man accepting effective contraception for the duration of treatment and one month after,
- Participant with affiliation to the French Health Care System "sécurité sociale",
- Written informed consent of the patient obtained.
Who cannot join
- 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
- Active chronic inflammatory disease, chronic active infection, evolving cancer
- A recent severe sepsis (7 days)
Show all 20Show fewer
- Hypersensitivity to Investgational Medical Product's active substances (colchicine) or to any of the excipients (including lactose, sucrose, microcrystalline cellulose, colloidal silica, magnesium stearate, colourants : E127, Dual Red 40 )
- Any known contra-indication to CMR or associated contract products (claustrophobia; intra-ocular metal foreign bodies, clips such as cerebral, carotid, or aortic aneurysm, cochlear implants, any implant held in by magnet, history of hypersensitivity to gadoteric acid or to gadolinium contrast agents or to meglumine). Patients with an implantable cardioverter-defibrillator (ICD) or pacemaker (PM) are also excluded due to the risk of imaging artifacts, which may compromise the reliable quantification of late gadolinium enhancement (LGE).
- Chronic treatment with corticosteroids or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or high-dose aspirin or immunosuppressant.
- Sarcoidosis
- Severe liver (Child Pugh C) or known renal dysfunction (known Glomerular Filtration Rate (GFR) less or equal to 30 ml/min according Cockroft),
- Cytopenia : hemoglobin less than 100 grams/L, white blood cell count less than 3.0 G/L, platelet count less than 100 G/L between admission and inclusion (within 7 days)
- Major digestive disorders (chronic diarrhea, inflammatory disease of the digestive tract as uncontrolled ulcerative colitis or active Crohn disease)
- Immunosuppression, spinal cord aplasia
- Hemopathy
- Hypereosinophilia more than 0.5 G/L between admission and inclusion
- Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive local laboratory test,
- Administration of any investigational drug or participation in another interventional trial, within 30 days before randomization,
- Participant under treatment having an interaction with colchicine [macrolides (telithromycin, azithromycin, clarithromycin, dirithromycin, erythromycin, josamycin, midecamycin, roxithromycin), pristinamycin,, cyclosporine, verapamil, all protease inhibitors, telaprevir, CYP3A4 powerful inhibitors, azole antifungals, vitamin K antagonists]
- Participant under legal protection: under guardianship (trusteeship or curatorship)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Unité de Soins Intensifs Cardiologiques - Hôpital Cardiovasculaire Louis Pradel
Bron, 69029
Thomas BOCHATON, +33472357549, thomas.bochaton@chu-lyon.fr
Julia CANTERINI, +33427856628, julia.canterini@chu-lyon.fr
- Recruiting
Institut de Cardiologie - APHP Pitié Salpêtrière
Paris, 75013
Mathieu KERNEIS, +33142163074, mathieu.kerneis@aphp.fr
Karine BROCHARD, +3142162959, karine.brochard-ext@aphp.fr
About this study
Official title: Colchicine 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
Myocarditis is an inflammatory disease of the heart, mostly caused by viruses. Patients with acute myocarditis are exposed to several complications: recurrence, ventricular arrhythmias (from 5 to 30%), heart failure (5-10%), death or heart transplantation (< 4%). To date, there is no specific treatment for myocarditis. Patient management only focuses upon empirical optimal care of arrhythmia and heart failure.
There is a strong rationale for using colchicine in acute myocarditis:
Read more
- the IL1 (Interleukin1) pathway plays a detrimental role in acute myocarditis. NLRP3 (NOD-like receptor family, pyrin domain containing 3) inflammasome assembly, and subsequent IL-1beta production, are profoundly inhibited by colchicine.
- colchicine has been shown to improve cardiac outcomes in inflammatory cardiac disorders, including pericarditis, coronary artery disease, and post pericardiotomy syndrome.
- In murine model of CVB3-induced myocarditis (coxsackievirus B3), colchicine improved myocarditis through reduction of NLRP3 activity.
- Small case series with improvement of left ejection fraction in myocarditis following low-dose colchicine in addition to conventional heart failure therapy have been reported.
With its pleiotropic anti-inflammatory effect in the pro-inflammatory cascade, reducing the myocardial damage and cell death induced during myocarditis, colchicine has the potential to reduce the risk of heart failure and ventricular arrhythmias. Finally, colchicine is a drug widely available, at low cost, and has a long and well-known safety record.
Read the detailed description
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.
- Conditions
- Acute Myocarditis
- Being tested
- Colchicine Pill, Placebo
- Keywords
- Myocarditis, Inflammation, Colchicine
- Medical subject headings
- Myocarditis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine PillDrug
Also called Colchicine
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Experimental | Participant receive in addition to standard of care therapy, six months of Colchicine Receives: Drug: Colchicine Pill |
| Placebo | Placebo comparator | Participant receive in addition to standard of care therapy, six months of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of Late Gadolinium Enhancement (LGE) evaluated on Cardiac Magnetic Resonance (CMR)
Extent of LGE (pourcentage of left ventricle mass) is evaluated (centralized reading by the Corelab) on CMR performed at six months and compared to baseline CMR (performed at the hospital admision or inclusion).
The inclusion visit takes place during the initial hospitalization.
Measured: Six months post-randomization
Composite Clinical primary outcome
Composite Clinical primary outcome is assessed during the study period at six months on:
- the rate of heart Failure or acute myocarditis recurrence;
- or the rate of clinically relevant chest pain (defined as leading to an unplanned/urgent consultation or hospitalization or requiring an additional treatment);
- or the rate of sustained ventricular arrhythmias;
- or the rate of left ventricular assistance;
- or the rate of heart transplantation;
- or the rate of cardiovascular death
Measured: Six months post-randomization
Secondary outcomes (23)
Safety of colchicine
Safety of colchicine is defined as :
- Rate of Serious Adverse Events related to colchicine
- Rate of permanent treatment discontinuation
- Rate of diarrhea
- Rate of nausea and/or vomiting
- Rate of myelotoxicity (evaluated on Complete Blood Count)
- Renal function evaluated by creatinine level and creatinine clearance (MDRD)
Measured: Six months post-randomization
Composite clinical secondary outcome
Composite Clinical secondary outcome is assessed during the study period at one year on:
- Rate of heart failure or acute myocarditis recurrence
- Rate of clinically relevant chest pain (defined as leading to an unplanned/urgent consultation or hospitalization or requiring an additional treatment)
- Rate of sustained ventricular arrhythmias
- Rate of left ventricular assistance or heart transplantation
- Rate of cardiovascular death
Measured: one year post-randomization
Rate of heart failure at 6 months
Rate of heart failure is a component of the composite clinical secondary endpoint. It is assessed at 6 months.
Measured: Six months post-randomization
Rate of acute myocarditis recurrence at 6 months
Rate of acute myocarditis recurrence is a component of the composite clinical secondary endpoint. It is assessed at 6 months.
Measured: Six months post-randomization
Rate of clinically relevant chest pain at 6 months
Rate of clinically relevant chest pain (defined as leading to an unplanned/urgent consultation or hospitalization or requiring an additional treatment) is a component of the composite clinical secondary endpoint. It is assessed at 6 months.
Measured: Six months post-randomization
Rate of sustained ventricular arrhythmias at 6 months
Rate of sustained ventricular arrhythmias is a component of the composite clinical secondary endpoint. It is assessed at 6 months.
Measured: Six months post-randomization
Rate of left ventricular assistance at 6 months
Rate of left ventricular assistance is a component of the composite clinical secondary endpoint. It is assessed at 6 months.
Measured: Six months post-randomization
Rate of heart transplantation at 6 months
Rate of heart transplantation is a component of the composite clinical secondary endpoint. It is assessed at 6 months.
Measured: Six months post-randomization
Rate of cardiovascular death at 6 months
Rate of cardiovascular death is a component of the composite clinical secondary endpoint. It is assessed at 6 months.
Measured: Six months post-randomization
Rate of heart failure at 1 year
Rate of heart failure is a component of the composite clinical secondary endpoint. It is assessed at 1 year.
Measured: One year post-randomization
Rate of acute myocarditis recurrence at 1 year
Rate ofacute myocarditis recurrence is a component of the composite clinical secondary endpoint. It is assessed at 1 year.
Measured: One year post-randomization
Rate of clinically relevant chest pain at 1 year
Rate of clinically relevant chest pain (defined as leading to an unplanned/urgent consultation or hospitalization or requiring an additional treatment) is a component of the composite clinical secondary endpoint. It is assessed at 1 year.
Measured: One year post-randomization
Rate of sustained ventricular arrhythmias at 1 year
Rate of sustained ventricular arrhythmias is a component of the composite clinical secondary endpoint. It is assessed at 1 year.
Measured: One year post-randomization
Rate of left ventricular assistance at 1 year
Rate of left ventricular assistance is a component of the composite clinical secondary endpoint. It is assessed at 1 year.
Measured: One year post-randomization
Rate of heart transplantation at 1 year
Rate of heart transplantation is a component of the composite clinical secondary endpoint. It is assessed at 1 year.
Measured: One year post-randomization
Rate of cardiovascular death at 1 year
Rate of cardiovascular death is a component of the composite clinical secondary endpoint. It is assessed at 1 year.
Measured: One year post-randomization
Left ventricular volume on Cardiac Magnetic Resonance (CMR)
Left Ventricular Ejection Fraction (LVEF), left ventricular end-diastolic and left ventricular end-systolic volumes are evaluated (centralized reading by the Corelab) on CMR performed at six months and compared to baseline CMR (performed at the hospital admision or inclusion).
Measured: Six months post-randomization
Left ventricular volume on transthoracic echocardiography (TTE)
Relative variation in Left ventricular ejection fraction (LVEF) between baseline and 6-months as determined by TTE.
Measured: 6 months post-randomization
Relative variation in Extent of late gadolinium enhancement (LGE) and edema
Relative variation in LGE and edema between baseline and six months determined centrally by the Corelab on the CMR
Measured: Six months post-randomization
Tissue properties evaluated on Cardiac Magnetic Resonance (CMR)
Cardiac magnetic resonance criteria: value of native T1 and T2 mapping (ms), pourcentage of extracellular volume
Measured: Six months post-randomization
Serum biomarkers
Serum biomarkers during the hospital period (eg: admission, 24h and 48h (after admission), inclusion or discharge) and at six months: Troponin (I or T according to investigator), N-terminal pro-brain natriuretic peptide (NT-pro BNP), C-Reactiv Protein (CRP) and Creatin Kinase (CK)
Measured: Six months post-randomization
Specific Inflammatory markers
Analysis of specific Inflammatory markers only for participating centers of biocollection at six months post-randomization versus baseline (inclusion; 24 hours and 48 hours post-inclusion) : interleukin 6 (IL-6), interleukin 1 beta (IL-1bβ) and ST2 (or soluble interleukin 1 receptor-like 1). Patients undergo two blood samples of 4 mL at inclusion ; 24 hours and 48 hours after the inclusion visit, if the patient is still in hospital; and at 6 months post-randomization.
Measured: Six months post-randomization
Ventricular premature complex (VPC) evaluated on Holter ElectroCardiogramm (ECG)
VPC burden on Holter ECG performed during the hopsital consultation at three months
Measured: three months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start16 Jul 2024
- Primary completion16 Jan 2028 (estimated)
- Study completion16 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute MyocarditisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, two arms, randomized (1:1), double blind, superiority study evaluating colchicine versus placebo administrated during six months among participants with acute myocarditis.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon, Fonds de Dotation ACTION
- Responsible party
- Sponsor
- Investigators
- Thomas BOCHATON, Study chair, Cardiovascular hospital Louis PradelMathieu KERNEIS, Study director, Department of Cardiology - Pitié Salpêtrière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855746
- Sponsor's protocol ID
- APHP211429
- Acronym
- ARGO
- Status last verified
- Feb 2026
- First submitted
- 21 Apr 2023
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tschope C, Cooper LT, Torre-Amione G, Van Linthout S. Management of Myocarditis-Related Cardiomyopathy in Adults. Circ Res. 2019 May 24;124(11):1568-1583. doi: 10.1161/CIRCRESAHA.118.313578.
PubMed 31120823Ammirati E, Cipriani M, Moro C, Raineri C, Pini D, Sormani P, Mantovani R, Varrenti M, Pedrotti P, Conca C, Mafrici A, Grosu A, Briguglia D, Guglielmetto S, Perego GB, Colombo S, Caico SI, Giannattasio C, Maestroni A, Carubelli V, Metra M, Lombardi C, Campodonico J, Agostoni P, Peretto G, Scelsi L, Turco A, Di Tano G, Campana C, Belloni A, Morandi F, Mortara A, Ciro A, Senni M, Gavazzi A, Frigerio M, Oliva F, Camici PG; Registro Lombardo delle Miocarditi. Clinical Presentation and Outcome in a Contemporary Cohort of Patients With Acute Myocarditis: Multicenter Lombardy Registry. Circulation. 2018 Sep 11;138(11):1088-1099. doi: 10.1161/CIRCULATIONAHA.118.035319.
PubMed 29764898Kyto V, Sipila J, Rautava P. Rate and patient features associated with recurrence of acute myocarditis. Eur J Intern Med. 2014 Dec;25(10):946-50. doi: 10.1016/j.ejim.2014.11.001. Epub 2014 Nov 7.
PubMed 25468248Peretto G, Sala S, Rizzo S, Palmisano A, Esposito A, De Cobelli F, Campochiaro C, De Luca G, Foppoli L, Dagna L, Thiene G, Basso C, Della Bella P. Ventricular Arrhythmias in Myocarditis: Characterization and Relationships With Myocardial Inflammation. J Am Coll Cardiol. 2020 Mar 10;75(9):1046-1057. doi: 10.1016/j.jacc.2020.01.036.
PubMed 32138965Imazio M, Brucato A, Cemin R, Ferrua S, Maggiolini S, Beqaraj F, Demarie D, Forno D, Ferro S, Maestroni S, Belli R, Trinchero R, Spodick DH, Adler Y; ICAP Investigators. A randomized trial of colchicine for acute pericarditis. N Engl J Med. 2013 Oct 17;369(16):1522-8. doi: 10.1056/NEJMoa1208536. Epub 2013 Aug 31.
PubMed 23992557Retnowati FD, Halawa DR, Maayah ZH, Abdallah AM. Targeting NLRP3 Inflammasomes in Myocarditis: Potential Therapeutic Strategies and Clinical Translation. Scientifica (Cairo). 2026 May 19;2026:6560386. doi: 10.1155/sci5/6560386. eCollection 2026.
PubMed 42163845
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine 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
- ClinicalTrials.gov ID
- NCT05855746
- Acronym / sponsor ID
- ARGO / APHP211429
- Conditions
- Acute Myocarditis
- Keywords
- Myocarditis, Inflammation, Colchicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon, Fonds de Dotation ACTION
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 16 Jan 2028 (estimated)
- Study completion
- 16 Jul 2028 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Myocarditis is an inflammatory disease of the heart, mostly caused by viruses. Patients with acute myocarditis are exposed to several complications: recurrence, ventricular arrhythmias (from 5 to 30%), heart failure (5-10%), death or heart transplantation (< 4%). To date, there is no specific treatment for myocarditis. Patient management only focuses upon empirical optimal care of arrhythmia and heart failure.
There is a strong rationale for using colchicine in acute myocarditis:
- the IL1 (Interleukin1) pathway plays a detrimental role in acute myocarditis. NLRP3 (NOD-like receptor family, pyrin domain containing 3) inflammasome assembly, and subsequent IL-1beta production, are profoundly inhibited by colchicine.
- colchicine has been shown to improve cardiac outcomes in inflammatory cardiac disorders, including pericarditis, coronary artery disease, and post pericardiotomy syndrome.
- In murine model of CVB3-induced myocarditis (coxsackievirus B3), colchicine improved myocarditis through reduction of NLRP3 activity.
- Small case series with improvement of left ejection fraction in myocarditis following low-dose colchicine in addition to conventional heart failure therapy have been reported.
With its pleiotropic anti-inflammatory effect in the pro-inflammatory cascade, reducing the myocardial damage and cell death induced during myocarditis, colchicine has the potential to reduce the risk of heart failure and ventricular arrhythmias. Finally, colchicine is a drug widely available, at low cost, and has a long and well-known safety record.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, two arms, randomized (1:1), double blind, superiority study evaluating colchicine versus placebo administrated during six months among participants with acute myocarditis.
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Experimental | Drug: Colchicine PillParticipant receive in addition to standard of care therapy, six months of Colchicine |
| Placebo | Placebo comparator | Drug: PlaceboParticipant receive in addition to standard of care therapy, six months of placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Symptom onset of 28 days or less,
- Myocarditis initially presenting with chest pain and/or Heart failure symptoms and/or palpitations
- Troponins superior to 99 percentile of reference value, at any time between admission and inclusion
- Myocarditis diagnostic confirmation (by Contrast-Enhanced Cardiac Magnetic Resonance (CMR), according to the Lake Louise criteria (2009 or later),
- No evidence for ischemic heart disease on coronary angiography or coronary computed tomography angiography for patients with age superior to 40-year-old with one or more cardiovascular risk factor (hypertension, smoking, hypercholesterolemia, diabetes, personal or family history of coronary artery disease),
Key exclusion criteria (20 listed)
- 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
- Active chronic inflammatory disease, chronic active infection, evolving cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine PillAlso: ColchicineParticipant 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 | Colchicine |
| PlaceboParticipant 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. | Drug | Placebo |
Primary outcome
Extent of Late Gadolinium Enhancement (LGE) evaluated on Cardiac Magnetic Resonance (CMR)
Time frame: Six months post-randomization
Extent of LGE (pourcentage of left ventricle mass) is evaluated (centralized reading by the Corelab) on CMR performed at six months and compared to baseline CMR (performed at the hospital admision or inclusion). The inclusion visit takes place during the initial hospitalization.
Composite Clinical primary outcome
Time frame: Six months post-randomization
Composite Clinical primary outcome is assessed during the study period at six months on: * the rate of heart Failure or acute myocarditis recurrence; * or the rate of clinically relevant chest pain (defined as leading to an unplanned/urgent consultation or hospitalization or requiring an additional treatment); * or the rate of sustained ventricular arrhythmias; * or the rate of left ventricular assistance; * or the rate of heart transplantation; * or the rate of cardiovascular death
23 secondary outcomes
Safety of colchicine
Time frame: Six months post-randomization
Composite clinical secondary outcome
Time frame: one year post-randomization
Rate of heart failure at 6 months
Time frame: Six months post-randomization
Rate of acute myocarditis recurrence at 6 months
Time frame: Six months post-randomization
Rate of clinically relevant chest pain at 6 months
Time frame: Six months post-randomization
Rate of sustained ventricular arrhythmias at 6 months
Time frame: Six months post-randomization
Rate of left ventricular assistance at 6 months
Time frame: Six months post-randomization
Rate of heart transplantation at 6 months
Time frame: Six months post-randomization
Rate of cardiovascular death at 6 months
Time frame: Six months post-randomization
Rate of heart failure at 1 year
Time frame: One year post-randomization
Rate of acute myocarditis recurrence at 1 year
Time frame: One year post-randomization
Rate of clinically relevant chest pain at 1 year
Time frame: One year post-randomization
Rate of sustained ventricular arrhythmias at 1 year
Time frame: One year post-randomization
Rate of left ventricular assistance at 1 year
Time frame: One year post-randomization
Rate of heart transplantation at 1 year
Time frame: One year post-randomization
Rate of cardiovascular death at 1 year
Time frame: One year post-randomization
Left ventricular volume on Cardiac Magnetic Resonance (CMR)
Time frame: Six months post-randomization
Left ventricular volume on transthoracic echocardiography (TTE)
Time frame: 6 months post-randomization
Relative variation in Extent of late gadolinium enhancement (LGE) and edema
Time frame: Six months post-randomization
Tissue properties evaluated on Cardiac Magnetic Resonance (CMR)
Time frame: Six months post-randomization
Serum biomarkers
Time frame: Six months post-randomization
Specific Inflammatory markers
Time frame: Six months post-randomization
Ventricular premature complex (VPC) evaluated on Holter ElectroCardiogramm (ECG)
Time frame: three months post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Background: PubMed 31120823Tschope C, Cooper LT, Torre-Amione G, Van Linthout S. Management of Myocarditis-Related Cardiomyopathy in Adults. Circ Res. 2019 May 24;124(11):1568-1583. doi: 10.1161/CIRCRESAHA.118.313578.
- Background: PubMed 29764898Ammirati E, Cipriani M, Moro C, Raineri C, Pini D, Sormani P, Mantovani R, Varrenti M, Pedrotti P, Conca C, Mafrici A, Grosu A, Briguglia D, Guglielmetto S, Perego GB, Colombo S, Caico SI, Giannattasio C, Maestroni A, Carubelli V, Metra M, Lombardi C, Campodonico J, Agostoni P, Peretto G, Scelsi L, Turco A, Di Tano G, Campana C, Belloni A, Morandi F, Mortara A, Ciro A, Senni M, Gavazzi A, Frigerio M, Oliva F, Camici PG; Registro Lombardo delle Miocarditi. Clinical Presentation and Outcome in a Contemporary Cohort of Patients With Acute Myocarditis: Multicenter Lombardy Registry. Circulation. 2018 Sep 11;138(11):1088-1099. doi: 10.1161/CIRCULATIONAHA.118.035319.
- Background: PubMed 25468248Kyto V, Sipila J, Rautava P. Rate and patient features associated with recurrence of acute myocarditis. Eur J Intern Med. 2014 Dec;25(10):946-50. doi: 10.1016/j.ejim.2014.11.001. Epub 2014 Nov 7.
- Background: PubMed 32138965Peretto G, Sala S, Rizzo S, Palmisano A, Esposito A, De Cobelli F, Campochiaro C, De Luca G, Foppoli L, Dagna L, Thiene G, Basso C, Della Bella P. Ventricular Arrhythmias in Myocarditis: Characterization and Relationships With Myocardial Inflammation. J Am Coll Cardiol. 2020 Mar 10;75(9):1046-1057. doi: 10.1016/j.jacc.2020.01.036.
- Background: PubMed 23992557Imazio M, Brucato A, Cemin R, Ferrua S, Maggiolini S, Beqaraj F, Demarie D, Forno D, Ferro S, Maestroni S, Belli R, Trinchero R, Spodick DH, Adler Y; ICAP Investigators. A randomized trial of colchicine for acute pericarditis. N Engl J Med. 2013 Oct 17;369(16):1522-8. doi: 10.1056/NEJMoa1208536. Epub 2013 Aug 31.
- Derived from this study: PubMed 42163845Retnowati FD, Halawa DR, Maayah ZH, Abdallah AM. Targeting NLRP3 Inflammasomes in Myocarditis: Potential Therapeutic Strategies and Clinical Translation. Scientifica (Cairo). 2026 May 19;2026:6560386. doi: 10.1155/sci5/6560386. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas BOCHATON study chair
Cardiovascular hospital Louis Pradel
Mathieu KERNEIS study director
Department of Cardiology - Pitié Salpêtrière Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine Pill in people with Acute Myocarditis, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas BOCHATON (+33472357549, thomas.bochaton@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of Late Gadolinium Enhancement (LGE) evaluated on Cardiac Magnetic Resonance (CMR) (time frame: Six months post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05855746, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.