A Phase 2 interventional study of Colchicine group (experimental arm) and Placebo group (control arm) in Myocardial Infarction, sponsored by Hospices Civils de Lyon. Completed at 8 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-01.
Sponsored by Hospices Civils de Lyon · Phase 2, Interventional, and Treatment
Inflammatory processes have been identified as key mediators of ischemia/ reperfusion injury in ST-segment elevation myocardial infarction. They add additional damage to the myocardium and are associated with clinical adverse events (heart failure and cardiovascular death) and poor myocardial recovery. All the different anti-inflammatory approaches to reduce reperfusion injury have been disappointing.
Colchicine is a well-known substance with potent anti-inflammatory properties. In a recent pilot study performed in 151 acute STEMI patients treated with primary percutaneous coronary intervention(PPCI) Deftereos et al. showed a 50% reduction of infarct size (creatine kinase release) with a short course treatment of colchicine in comparison to placebo.
One mechanism to explain this effect could be the reduction of adverse left ventricular (LV) remodelling. LV remodelling is part of the healing process of myocardium after MI. It is defined as the end diastolic volume (EDV) increase in the first months after MI. Adverse LV remodelling is increased by inflammation and ultimately leads to heart failure.
Our main hypothesis is that colchicine with its anti-inflammatory properties significantly reduces the initiation of adverse LV remodelling, together with a significant reduction of infarct size and microvascular obstruction in comparison to placebo in acute STEMI patients referred for PPCI.
After inclusion and randomisation, patients will receive the first part of their experimental treatment: colchicine or placebo before PCI, then, the second part after PCI and during 5 days. They will be followed up during their hospitalization and until one year. In order to evaluate LV remodelling, two cardiac magnetic resonance studies will be performed during their participation: one during their hospitalization and a second at 3 months. At 1 year, adverse events will be collected by phone.
2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.
This study's enrollment of 194 is above the median of 150 across 1,314 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patients will receive an oral bolus of colchicine of 2 mg followed by 0.5 mg b.i.d. during 5 days.
Drug: Colchicine group (experimental arm)
The patients will receive an oral bolus of placebo of 2 mg followed by 0.5 mg b.i.d. during 5 days.
Drug: Placebo group (control arm)
In the experimental group, patients will receive colchicine, starting with a loading dose of 2 mg at the time of revascularization and continuing with 0.5 mg twice daily (b.i.d) for 5 days.
In the placebo group, patients will receive placebo, starting with a loading dose of 2 mg at the time of revascularization and continuing with 0.5 mg twice daily for 5 days.
infarct size (in % of LV mass) as estimated by CMR
The primary endpoint will be the infarct size as estimated by CMR at 5 days follow-up between both groups
Time frame: 5 days
LV ejection fraction
Time frame: At 5 days
Microvascular obstruction (in % of LV mass)
Time frame: At 5 days
Absolute adverse left ventricular remodeling (mL)
Time frame: at 3 months
Relative ventricular remodeling (%)
Time frame: at 3 months
Infarct size in % of LV mass
Infarct size in % of LV mass assessed by ce-CMR
Time frame: At 3 months
LVEDV
LVEDV (indexed to body surface area) as determined by CMR at the acute phase and 3 months follow-up respectively
Time frame: At 3 months
LVESV
LVEDV (indexed to body surface area) as determined by CMR at the acute phase and 3 months follow-up respectively
Time frame: at 3 months
Relative LV ejection fraction
Time frame: 5 days
Percent of thrombi in the LV
Time frame: At 5 days
Incidence of major adverse cardiovascular events
All cause death, cardiovascular death, heart failure worsening during initial hospitalization, hospitalization for heart failure, non-fatal myocardial infarction, life-threatening ventricular arrhythmias and atrial fibrillation.
Time frame: at 3 months
Incidence of major adverse cardiovascular events
All cause death, cardiovascular death, heart failure worsening during initial hospitalization, hospitalization for heart failure, non-fatal myocardial infarction, life-threatening ventricular arrhythmias and atrial fibrillation.
Time frame: At 12 months
Quality of life assessed by the EuroQol-5D (EQ5D) questionnaire
Evaluation of quality of life by the EQ5D questionnaire ( scale on which the best state is marked 100 and the worst state is marked 0).
Time frame: At 12 months
Dosage of inflammation biomarkers
Dosage of inflammation biomarkers * For all centers: neutrophil count, C-reactive protein, hematology, Platelets, fibrinogen. * For the centers participating to the BioCollection: interleukin 6, interleukin 8, interleukin 1β and interleukin 18, complement system components.
Time frame: up to 3 months
number of treatment discontinuation
Time frame: 5 days
number of adverse events
(diarrhea, nausea/vomiting and myelotoxicity, renal function at 48H).
Time frame: up to 5 days
Ran from Jul 2018 to primary completion in Nov 2020, 27 months.
Of 45 phase 2 interventional studies under Myocardial Infarction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 42. This study's 27 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Colchicine