Overview

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