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Effect of Colchicine in Patients With Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04218786
Recruitment Status : Enrolling by invitation
First Posted : January 6, 2020
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
Rawalpindi Institute of Cardiology
Information provided by (Responsible Party):
Nismat Javed, Shifa Tameer-e-Millat University

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Myocardium; Injury Myocardial Infarction Myocardial Ischemia Drug: Colchicine Drug: Placebo oral tablet Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Outcomes of Low-dose Colchicine in Patients With Myocardial Infarction: A Randomized Controlled Trial
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Colchicine

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04218786


Locations
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Pakistan
Rawalpindi Institute of Cardiology
Rawalpindi, Pakistan, 46000
Sponsors and Collaborators
Shifa Tameer-e-Millat University
Rawalpindi Institute of Cardiology
Investigators
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Principal Investigator: Nismat Javed, MBBS student Shifa College of Medicine, Shifa Tameer-e-Millat University
Study Director: Jahanzeb Malik, MBBS (2011) Rawalpindi Institute of Cardiology
Study Chair: Adeel ur Rehman, MBBS, FCPS Rawalpindi Institute of Cardiology
More Information
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Publications:

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Responsible Party: Nismat Javed, Principal Investigator, Shifa Tameer-e-Millat University
ClinicalTrials.gov Identifier: NCT04218786    
Other Study ID Numbers: STMU2020
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Nismat Javed, Shifa Tameer-e-Millat University:
colchicine; outcome: myocardial infarction
Additional relevant MeSH terms:
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Myocardial Infarction
Myocardial Ischemia
Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
 Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents