Trial | NCT04218786  Report issue

Title

Effect of Colchicine in Patients With Myocardial Infarction
Outcomes of Low-dose Colchicine in Patients With Myocardial Infarction: A Randomized Controlled Trial

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Intervention/Treatment

    Colchicine ...

  • Study Participants

    0
Over the past years, a substantial volume of evidence has accumulated identifying inflammatory processes as key mediators of the deleterious effects of ischemia/reperfusion-related phenomena in patients presenting with ST-segment-elevation myocardial infarction (STEMI). Nevertheless, equally impressive is the lack of clinically applicable therapeutic strategies that could mitigate these processes, thus providing significant cardioprotection. Despite the well-known fact that inflammation plays an important role in coronary artery disease development and progression, there have been few attempts to systematically examine the potential role of anti-inflammatory treatment in this setting, possibly because of a lack in anti-inflammatory agents without the adverse cardiovascular safety profile of corticosteroids and nonsteroidal anti-inflammatory drugs. Colchicine is a substance with potent anti-inflammatory properties, having a unique mechanism of action, which allows for safe use in patients with cardiovascular disease.

The purpose of the present clinical study is to test the hypothesis that a short course of treatment with colchicine could lead to reduced major adverse cardiovascular events (MACE) in acute MI.
Over the past years, a substantial volume of evidence has accumulated identifying inflammatory processes as key mediators of the deleterious effects of ischemia/reperfusion-related phenomena in patients presenting with ST-segment-elevation myocardial infarction (STEMI). Nevertheless, equally impressive is the lack of clinically applicable therapeutic strategies that could mitigate these processes, thus providing significant cardioprotection.

Despite the well-known fact that inflammation plays an important role in coronary artery disease development and progression, there have been few attempts to systematically examine the potential role of anti-inflammatory treatment in this setting, possibly because of a lack in anti-inflammatory agents without the adverse cardiovascular safety profile of corticosteroids and nonsteroidal anti-inflammatory drugs. Some anti-inflammatory agents, like pexelizumab, are focused on complement cascade.Another agent is Varespladib, which targets sPLA2 that causes oxidative stress and inflammation. There are other therapeutic targets that have been widely investigated. Colchicine is a substance with potent anti-inflammatory properties, having a unique mechanism of action, which allows for safe use in patients with cardiovascular disease.

Colchicine binds to non-polymerized tubulin, forming a stable complex that effectively inhibits the dynamic of microtubules, depolymerizing them. Thus, any process requiring changes in the cell cytoskeleton, such as cellular mitosis, exocytosis and neutrophil motility, is affected. Colchicine has an important effect on atrial myocytes, changing the atrial response to autonomic effects (reducing the sympathetic activity and increasing the parasympathetic one). Due to this particular mode of action, colchicine has been indicated in atrial fibrillation post-cardiac surgery. A similar trial is being conducted to investigate any effusions or syndromes that occur after myocardial infarction.

The purpose of the present clinical study is to test the hypothesis that a short course of treatment with colchicine could lead to reduced major adverse cardiovascular events (MACE) in acute MI.
Study Started
Dec 31
2025
Anticipated
Primary Completion
Mar 31
2026
Anticipated
Study Completion
Jun 30
2026
Anticipated
Last Update
Apr 12
2023

Drug Colchicine

The tablet will be given once daily for the span of the study

Drug Placebo oral tablet

The tablet will be given once daily for the span of the study

Colchicine Group Active Comparator

This group will receive low dose colchicine, 0.5 mg.

Placebo group Placebo Comparator

This group will receive a placebo drug with a similar shape and mass as that to experimental drug

Criteria 

Inclusion Criteria:

All patients 18 years or above presenting in emergency department with acute myocardial infarction. These patients will be requested to take the medication at the time of discharge after stabilization and management

Exclusion Criteria:

Patients with prior myocardial infarction 30 days before
Patients with ischemic cardiomyopathy
Age <18 or > 80 years
Active inflammatory or infectious disease or known malignancy
Known hypersensitivity to colchicine,
renal failure (eGFR <30ml.min.1.73m)
hepatic failure
Stent thrombosis
Cardiac arrest or cardiogenic shock as presenting symptoms
No Results Posted