COLchicine to Prevent Sympathetic Denervation After an Acute Myocardial Infarction (COLD-MI)

University Hospital Center (CHU)

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Myocardial Infarction, Acute

Treatments

Drug: Colchicine

Study type

Interventional

Funder types

Other

Identifiers

NCT04420624

RECHMPL18_0459

2020-000098-25 (Registry Identifier)

Details and patient eligibility

About

This study evaluates the benefit of colchicine on induced denervation after myocardial infarction. Patients who have suffered a documented De Novo myocardial infarction and completed a revascularization procedure will receive either colchicine on top of standard therapy, compared to standard therapy alone (1:1 allocation ratio). Colchicine 1mg (or 0.5mg) will be initiated within 48h after percutaneous revascularization and prescribed for one month.

Full description

COLD-MI study aims to explore colchicine's impact on myocardial denervation following reperfused acute myocardial infarction. Acute myocardial infarction is the leading cause of heart failure (HF). It induces myocardial denervation predisposing to ventricular rhythm disorders and death. This denervation linked to infarction's size occurs by direct ischaemic mechanisms during the initial coronary occlusion (initially non-vascularised zone) and secondarily by cardiac remodelling in the context of the heart failure (HF). In usual practice, cardiac denervation which intensity is correlated with rhythm and mortality risks, can be evaluated by scintigraphy. In a murine reperfusion model of ischemia, the direct anti-inflammatory effect of colchicine reduces the size of the necrosis and improves post-ischemic remodeling. This suggests that colchicine may reduce myocardial denervation.

Enrollment

54 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age from 18 to 80 year old
Hospitalization within 12 hours of onset of acute chest pain
Patient must have suffered a documented acute myocardial infarction
Coronary occlusion on initial angiography (culprit artery with aTIMI (Thrombolysis in Myocardial Infarction) flow 1 or 0)
Patient eligible for a revascularization procedure by PTCA (Percutaneous transluminal coronary angioplasty)

Exclusion criteria

Patients with a history of myocardial infarction prior to the current episode
Patient in cardiogenic shock or with hemodynamic instability
Patients with severe hepatic or renal dysfunction (GFR ≤30 mL/min)
Pregnant women or women of childbearing age without contraception
Treatment with a potent CYP3A4 inhibitor or a P-glycoprotein inhibitor in patients with renal or hepatic impairement
Association with macrolides (except spiramycin)
Association with pristinamycin