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Myocardial InfarctionPhase 2COVERT-MINCT03156816

COlchicine for Left VEntricular Remodeling Treatment in Acute Myocardial Infarction

A Phase 2 study testing Colchicine group (experimental arm) in people with Myocardial Infarction, run by Hospices Civils de Lyon at 8 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Myocardial Infarction
What is being tested?
Colchicine group (experimental arm)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
194 participants
Where
8 sitesFrance
Study dates
23 Jul 2018to 16 Aug 2021
Phase
Phase 2
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients, aged over 18 and <80 years,
  • Presenting within 12 hours of chest pain onset,
  • With ST segment elevation ≥ 0.2 mV in two contiguous leads or new onset of left bundle branch block,
  • Referral for primary percutaneous coronary intervention (PPCI).
  • Preliminary oral informed consent followed by signed informed consent as soon as possible
  • With an initially occluded coronary artery (TIMI angiographic flow of the culprit coronary artery ≤1)

Who cannot join

  • Patients with any legal protection measure,
  • Patients without any health coverage,
  • Patients with loss of consciousness or confused
  • Patients with a history of prior myocardial infarction
  • Patients with cardiogenic shock as defined by a systolic blood pressure <90 mmHg, despite 30 minutes of fluid challenge or requiring intravenous vasoactive agents (dobutamine, noradrenaline, adrenaline)
  • Patient with severe liver or known renal dysfunction (known GFR≤30 ml/min)
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  • Patient with known history of severe drug intolerance to colchicine
  • Female patients currently pregnant or women of childbearing age not using contraception (oral diagnosis)
  • Patients with any obvious contraindication to magnetic resonance imaging (claustrophobia, pace maker, defibrillator….)
  • Patients treated by macrolides or pristinamycin
  • Chronic treatment with COLCHICINE (Mediterranean familial fever mainly)
  • Patient with lactose intolerance
  • Patient with swallowing disorders

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

France8 sites

  • Centre Hospitalier Universitaire Angers

    Angers

  • Hôpital Louis Pradel

    Bron, 69677

  • Hôpital Saint Joseph

    Lyon

  • CHU Arnaud de Villeneuve

    Montpellier

  • CHU de Mulhouse

    Mulhouse

  • CHU de Poitiers

    Poitiers

  • CHU de Rangueil

    Toulouse

  • CHRU de Tours

    Tours

Other trials in France

About this study

Official title: COlchicine for Left VEntricular Remodeling Treatment in Acute Myocardial Infarction, a Phase II, Multicenter, Randomized, Double Blinded, Placebo Controlled Clinical Trial

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.

Read more

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.

Being tested
Colchicine group (experimental arm), Placebo group (control arm)
Keywords
Myocardial Infarction, STEMI, Inflammation, Left ventricular remodeling, Colchicine, CMR
Medical subject headings
Myocardial Infarction, ST Elevation Myocardial Infarction, Inflammation, Ventricular Remodeling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Colchicine group (experimental arm)Drug

    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.

  • Placebo group (control arm)Drug

    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.

Study groups in NCT03156816
Study groupRoleWhat they receive
ColchicineExperimentalThe patients will receive an oral bolus of colchicine of 2 mg followed by 0.5 mg b.i.d. during 5 days.
Receives: Drug: Colchicine group (experimental arm)
Control armPlacebo comparatorThe patients will receive an oral bolus of placebo of 2 mg followed by 0.5 mg b.i.d. during 5 days.
Receives: Drug: Placebo group (control arm)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 5 days

Secondary outcomes (15)

  1. LV ejection fraction

    Measured: At 5 days

  2. Microvascular obstruction (in % of LV mass)

    Measured: At 5 days

  3. Absolute adverse left ventricular remodeling (mL)

    Measured: at 3 months

  4. Relative ventricular remodeling (%)

    Measured: at 3 months

  5. Infarct size in % of LV mass

    Infarct size in % of LV mass assessed by ce-CMR

    Measured: At 3 months

  6. LVEDV

    LVEDV (indexed to body surface area) as determined by CMR at the acute phase and 3 months follow-up respectively

    Measured: At 3 months

  7. LVESV

    LVEDV (indexed to body surface area) as determined by CMR at the acute phase and 3 months follow-up respectively

    Measured: at 3 months

  8. Relative LV ejection fraction

    Measured: 5 days

  9. Percent of thrombi in the LV

    Measured: At 5 days

  10. 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.

    Measured: at 3 months

  11. 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.

    Measured: At 12 months

  12. 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).

    Measured: At 12 months

  13. 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.

    Measured: up to 3 months

  14. number of treatment discontinuation

    Measured: 5 days

  15. number of adverse events

    (diarrhea, nausea/vomiting and myelotoxicity, renal function at 48H).

    Measured: up to 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2017
  2. Study start23 Jul 2018
  3. Primary completion8 Nov 2020
  4. Study completion16 Aug 2021

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03156816
Sponsor's protocol ID
69HCL17_0034
Other IDs
2017-004090-13, 2017
Acronym
COVERT-MI
Status last verified
Jan 2022
First submitted
16 May 2017
Last updated
1 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mewton N, Roubille F, Bresson D, Prieur C, Bouleti C, Bochaton T, Ivanes F, Dubreuil O, Biere L, Hayek A, Derimay F, Akodad M, Alos B, Haider L, El Jonhy N, Daw R, De Bourguignon C, Dhelens C, Finet G, Bonnefoy-Cudraz E, Bidaux G, Boutitie F, Maucort-Boulch D, Croisille P, Rioufol G, Prunier F, Angoulvant D. Effect of Colchicine on Myocardial Injury in Acute Myocardial Infarction. Circulation. 2021 Sep 14;144(11):859-869. doi: 10.1161/CIRCULATIONAHA.121.056177. Epub 2021 Aug 23.

    PubMed 34420373

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Colchicine group (experimental arm) in people with Myocardial Infarction, run by Hospices Civils de Lyon at 8 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 6 inclusion and 13 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: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

infarct size (in % of LV mass) as estimated by CMR (time frame: 5 days). 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 NCT03156816, which also lists 1 linked publication.

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 1 Aug 2025.

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