COLchicine to Prevent Sympathetic Denervation After an Acute Myocardial Infarction

NCT04420624 | Terminated Phase 2

• 2 other identifiers: RECHMPL18_04592020-000098-25
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction, Acute

Keywords

Myocardial infarction; Sympathetic denervation; Heart failure

Outcome Measures

Primary Outcomes (1)

• Percentage of myocardial denervation

  assess by MIBG (méta-iodobenzylguanidine)-nuclear cardiac imaging

  6 month

Secondary Outcomes (32)

• Change in the heart-to-mediastinum ratio

  6 month

• Left Ventricular Ejection Fraction in percent

  6 month

• Left Ventricular Ejection Fraction in percent

  6 month

• Left Ventricular Ejection Fraction in percent

  1 month

• Change in Sinus variability

  6 month

Study Arms (2)

Colchicine

EXPERIMENTAL

colchicine and standard therapy

Drug: Colchicine

Comparator

NO INTERVENTION

standard therapy

Interventions

Colchicine DRUG

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

Also known as: no other name

Colchicine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

UH Montpellier

Montpellier, 34090, France

Location

MeSH Terms

Conditions

Myocardial Infarction; Heart Failure

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, phase IIb, monocentric, randomized, open labeled with 2 parallel study arms.

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: June 9, 2020
• Study Start: December 4, 2020
• Primary Completion: May 24, 2022
• Study Completion: May 24, 2022
• Last Updated: September 30, 2025

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)