Effect of Colchicine in Patients With Myocardial Infarction

April 11, 2023 updated by: Nismat Javed, Shifa Tameer-e-Millat University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Rawalpindi, Pakistan, 46000
        • Rawalpindi Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Colchicine Group
This group will receive low dose colchicine, 0.5 mg.
Drug: Colchicine
The tablet will be given once daily for the span of the study
Placebo Comparator: Placebo group
This group will receive a placebo drug with a similar shape and mass as that to experimental drug
Drug: Placebo oral tablet
The tablet will be given once daily for the span of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major cardiovascular adverse events (number of events)
Time Frame: 3 months

This outcome will be assessed using a questionnaire. The following headings will be used:

  • Cardiovascular death (number of events)
  • Non-fatal myocardial infarction (number of events)
  • Resuscitated cardiac arrest (number of events)
  • Hospitalization for unstable angina (number of events) For each heading, the total number of events will be recorded and the numbers will all be added to calculate 'Major Adverse Cardiovascular Events' in form of number of events. This outcome has no specific values of measure but a discrete numerical value
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Troponin I (ng/ml)
Time Frame: 3 months
This workup will be recorded on the same questionnaire as a numerical value with its specific unit of measure upon followup of patient.
3 months
Creatine Kinase-Myocardial Band (IU/L)
Time Frame: 3 months
This workup will be recorded on the same questionnaire as a numerical value with its specific unit of measure upon followup of patient.
3 months
C-reactive protein (mg/L)
Time Frame: 3 months
This workup will be recorded on the same questionnaire as a numerical value with its specific unit of measure upon followup of patient.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shifa Tameer-e-Millat University

Collaborators

Rawalpindi Institute of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2025

Primary Completion (Anticipated)

March 1, 2026

Study Completion (Anticipated)

June 1, 2026

Study Registration Dates

First Submitted

January 1, 2020

First Submitted That Met QC Criteria

January 3, 2020

First Posted (Actual)

January 6, 2020

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STMU2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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