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Completed

NCT Number: NCT03156816

COlchicine for Left VEntricular Remodeling Treatment in Acute Myocardial Infarction

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Inflammation Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases Ventricular Remodeling

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Universitaire Angers, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

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.

Primary outcomes

  1. infarct size (in % of LV mass) as estimated by CMR

    Time frame: 5 days

    The primary endpoint will be the infarct size as estimated by CMR at 5 days follow-up between both groups

Secondary outcomes

  1. LV ejection fraction

    Time frame: At 5 days

  2. Microvascular obstruction (in % of LV mass)

    Time frame: At 5 days

  3. Absolute adverse left ventricular remodeling (mL)

    Time frame: at 3 months

  4. Relative ventricular remodeling (%)

    Time frame: at 3 months

  5. Infarct size in % of LV mass

    Time frame: At 3 months

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

  6. LVEDV

    Time frame: At 3 months

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

  7. LVESV

    Time frame: at 3 months

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

  8. Relative LV ejection fraction

    Time frame: 5 days

  9. Percent of thrombi in the LV

    Time frame: At 5 days

  10. Incidence of major adverse cardiovascular events

    Time frame: at 3 months

    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.

  11. Incidence of major adverse cardiovascular events

    Time frame: At 12 months

    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.

  12. Quality of life assessed by the EuroQol-5D (EQ5D) questionnaire

    Time frame: At 12 months

    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).

  13. Dosage of inflammation biomarkers

    Time frame: up to 3 months

    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.

  14. number of treatment discontinuation

    Time frame: 5 days

  15. number of adverse events

    Time frame: up to 5 days

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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: COVERT-MI

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
May 17, 2017
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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