COlchicine for Left VEntricular Remodeling Treatment in Acute Myocardial Infarction

  • STATUS
    Recruiting
  • End date
    Jan 24, 2022
  • participants needed
    194
  • sponsor
    Hospices Civils de Lyon
Updated on 24 May 2021
chest pain
heart failure
myocardial infarction
stemi
infarct
percutaneous coronary intervention
ischemia
st elevation myocardial infarction
reperfusion injury
left bundle branch block
acute myocardial infarction
revascularisation
reperfusion therapy

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. 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.

Details
Condition Myocardial Infarction, Ischemic Heart Disease, Heart Attack (Myocardial Infarction), Cardiac Ischemia, Myocardial Ischemia, heart attack, myocardial infarction (mi), cardiac infarction, heart attacks, myocardial necrosis
Treatment Colchicine group (experimental arm), Placebo group (control arm)
Clinical Study IdentifierNCT03156816
SponsorHospices Civils de Lyon
Last Modified on24 May 2021

Eligibility

Yes No Not Sure

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 GFR30 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
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