COLchicine to Prevent Sympathetic Denervation After an Acute Myocardial Infarction

NCT ID: NCT04420624

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-04
• Study Completion Date: 2022-05-24

Brief 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.

Detailed 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.

Conditions

Myocardial Infarction, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Colchicine

colchicine and standard therapy

Group Type: EXPERIMENTAL

Colchicine

Intervention Type: DRUG

1 mg (or 0.5mg) tablet of colchicine taken once a day for 1 month

Comparator

standard therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Colchicine

1 mg (or 0.5mg) tablet of colchicine taken once a day for 1 month

Intervention Type: DRUG

Other Intervention Names

no other name

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UH Montpellier

Montpellier, , France

Countries

France

Other Identifiers

2020-000098-25

Identifier Type: REGISTRY

Identifier Source: secondary_id

RECHMPL18_0459

Identifier Type: -

Identifier Source: org_study_id