COLchicine to Prevent Sympathetic Denervation After an Acute Myocardial Infarction

• Status: Active, not recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Montpellier
• Treatments: Colchicine

Criteria

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