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Myocardial Infarction, AcutePhase 2/3COLD-MINCT04420624

COLchicine to Prevent Sympathetic Denervation After an Acute Myocardial Infarction

A Phase 2/3 study testing Colchicine in people with Myocardial Infarction, Acute, run by University Hospital, Montpellier at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Myocardial Infarction, Acute
What is being tested?
Colchicine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteFrance
Study dates
4 Dec 2020to 24 May 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • UH Montpellier

    Montpellier, 34090

Other trials in France

About this study

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.

Read the 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.

Being tested
Colchicine
Keywords
Myocardial infarction, Sympathetic denervation, Heart failure
Medical subject headings
Myocardial Infarction, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ColchicineDrug

    Also called no other name

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

Study groups in NCT04420624
Study groupRoleWhat they receive
ColchicineExperimentalcolchicine and standard therapy
Receives: Drug: Colchicine
ComparatorNo interventionstandard therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of myocardial denervation

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

    Measured: 6 month

Secondary outcomes (32)

  1. Change in the heart-to-mediastinum ratio

    The heart-to-mediastinum (H/M) ratio, the heart count normalized for the mediastinum count, is used as a quantitative index in cardiac 123 I-MIBG imaging.

    Measured: 6 month

  2. Left Ventricular Ejection Fraction in percent

    By transthoracic echocardiogram (TTE)

    Measured: 6 month

  3. Left Ventricular Ejection Fraction in percent

    By MIBG (méta-iodobenzylguanidine)-nuclear cardiac imaging

    Measured: 6 month

  4. Left Ventricular Ejection Fraction in percent

    By transthoracic echocardiogram (TTE)

    Measured: 1 month

  5. Change in Sinus variability

    by 24 hours holter recording : SDNN (Standard Deviation of NN intervals) will be measured

    Measured: 6 month

  6. Change in Sinus variability

    by 24 hours holter recording : SDNN (Standard Deviation of NN intervals) will be measured

    Measured: 1 month

  7. Basic ECG parameters (QRS duration)

    Measured: 6 month

  8. Basic ECG parameters (QRS duration)

    Measured: 1 month

  9. Basic ECG parameters (corrected QT)

    Measured: 1 month

  10. Basic ECG parameters (corrected QT)

    Measured: 6 month

  11. Number of ventricular extrasystole (2 or 3 VES) per 24 hours on the Holter

    Measured: 6 month

  12. Number of bursts (2 or 3 VES) per 24 hours on the Holter

    Measured: 1 month

  13. Number of bursts (2 or 3 VES) per 24 hours on the Holter

    Measured: 6 month

  14. Number of ventricular or supraventricular tachycardia (>3 VES) episodes per 24 hours

    Measured: 1 month

  15. Number of ventricular or supraventricular tachycardia (>3 VES) episodes per 24 hours

    Measured: 6 month

  16. Time from randomization to death (total mortality)

    Measured: 6 month

  17. Time from randomization to heart failure hospitalization

    Measured: 6 month

  18. Time from randomization to all-cause hospitalization

    Measured: 6 month

  19. Variations in the levels of neurotrophic molecular markers

    Concentration of NGF ng/mL

    Measured: Between hospitalization and 1 month

  20. Variations in the levels of neurotrophic molecular markers

    Concentration of NGF ng/mL

    Measured: Between 1 month and 6 months

  21. Variations in the levels of neurotrophic molecular markers

    Concentration of proNGF ng/mL

    Measured: Between hospitalization and 1 month

  22. Variations in the levels of neurotrophic molecular markers

    Concentration of proNGF ng/mL

    Measured: Between 1 month and 6 months

  23. Variations in the levels of neurotrophic molecular markers

    Concentration of BDNF ng/mL

    Measured: Between hospitalization and 1 month

  24. Variations in the levels of neurotrophic molecular markers

    Concentration of BDNF ng/mL

    Measured: Between 1 month and 6 months

  25. Biological evaluation of infarction size Creatine PhosphoKinase (CPK)

    Area Under Curve (AUC) of CPK

    Measured: During hospitalization (Day 1 to Day 5)

  26. Biological evaluation of infarction size (troponin)

    Area Under Curve (AUC) of Troponin

    Measured: During hospitalization (Day 1 to Day 5)

  27. Post infarction systemic inflammation evaluation

    Concentration of biomarkers from blood : CRP (mg/L)

    Measured: Between hospitalization and 1 month

  28. Post infarction systemic inflammation evaluation

    Concentration of biomarkers from blood : CRP (mg/L)

    Measured: Between 1 month and 6 months

  29. Post infarction systemic inflammation evaluation

    Concentration of biomarkers from blood : sST2 (ng/mL)

    Measured: Between hospitalization and 1 month

  30. Post infarction systemic inflammation evaluation

    Concentration of biomarkers from blood : sST2 (ng/mL)

    Measured: Between 1 month and 6 months

  31. Infarct size in percentage of left ventricular

    Measured: 6 month

  32. Number of Adverse event

    Comparison of adverse events between 2 arms

    Measured: from randomization to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2020
  2. Study start4 Dec 2020
  3. Primary completion24 May 2022
  4. Study completion24 May 2022

Why it stopped: Inclusion period completed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, phase IIb, monocentric, randomized, open labeled with 2 parallel study arms.
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04420624
Sponsor's protocol ID
RECHMPL18_0459
Other IDs
2020-000098-25
Acronym
COLD-MI
Status last verified
Dec 2022
First submitted
29 Apr 2020
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huet F, Mariano-Goulart D, Aguilhon S, Delbaere Q, Lacampagne A, Fauconnier J, Leclercq F, Macia JC, Akodad M, Jammoul N, Prunier F, Mewton N, Angoulvant D, Lozza C, Soltani S, Rodier A, Grandemange S, Dupuy AM, Cristol JP, Amico M, Nagot N, Roubille F. Colchicine to prevent sympathetic denervation after acute myocardial infarction: the COLD-MI trial. Eur Heart J. 2024 Mar 1;45(9):725-727. doi: 10.1093/eurheartj/ehae042. No abstract available.

    PubMed 38289979

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Colchicine in people with Myocardial Infarction, Acute, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Inclusion period completed). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of myocardial denervation (time frame: 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04420624, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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