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Mechanistic Effects 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: NCT02995512
Recruitment Status : Withdrawn (feasibility)
First Posted : December 16, 2016
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
The aim of this study is to determine the immuno-modulatory mechanistic effects of colchicine in patients with myocardial infarction (MI). Investigators hypothesize that colchicine exerts its anti-inflammatory properties by switching the metabolism of neutrophils, thereby reducing the expression of adhesion molecules responsible for their recruitment in MI.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Colchicine 0.6 mg tablets Phase 4

Detailed Description:

This is a pilot study to explore the mechanistic effects of colchicine in patients with MI. The study will be conducted sequentially in 3 parts:

  1. Blood will be collected from up to 10 healthy volunteers for protocol development. (Group 1).
  2. Blood will be collected from 20 MI patients within 24 hours of presentation at New York University (NYU) Langone Medical Center and Bellevue Hospital Center (BHC). Neutrophil adhesion to human aortic endothelial cells, quantitative expression of adhesion molecules on the surface of neutrophils, quantitative levels of adhesion molecules on neutrophils and endothelial cells, and neutrophil metabolism, using a Seahorse Analyzer will be evaluated pre- and post-addition of in vitro colchicine. (Group 2)
  3. The standard low-dose loading regimen of colchicine (1.2 mg followed by 0.6 mg one hour later) will be administered to 20 patients with MI at BHC. Blood will be collected prior to drug administration, 2 to 3 hours after completion of the colchicine load, and 23 to 24 hours after the completion of the colchicine load. Neutrophil adhesion to human aortic endothelial cells, quantitative expression of adhesion molecules on the surface of neutrophils, quantitative levels of adhesion molecules on neutrophils and endothelial cells, and neutrophil metabolism will be evaluated pre- and post-addition of in vitro colchicine (exact markers will be determined based on the results of in viro studies above). (Group 3)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mechanistic Effects of Colchicine in Patients With Myocardial Infarction A Single Center Phase 4 Single Arm Open-label Study Evaluating the FDA-approved Drug, Colchicine, at the FDA-approved Gout Dose in Patients With Myocardial Infarction
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : September 12, 2018
Actual Study Completion Date : September 12, 2018

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Heart Attack
Drug Information available for: Colchicine

Arm Intervention/treatment
Experimental: Myocardial Infarction (MI) Patients Drug: Colchicine 0.6 mg tablets
1.2 mg PO followed by 0.6 mg PO 1 hour later




Primary Outcome Measures :
  1. Number of neutrophils adherent to TNFα-stimulated endothelial cells [ Time Frame: 1 Day ]
    Metabolism of neutrophils will be measured using the Seahorse assay.


Secondary Outcome Measures :
  1. Levels of adhesion molecules on neutrophils and endothelial cells quantified using PCR [ Time Frame: 1 Day ]
    Metabolism of neutrophils will be measured using the Seahorse assay.

  2. Expression of adhesion molecules on the surface of neutrophils assessed via flow cytometry [ Time Frame: 1 Day ]
    Measurements of L-selectin, CD11b, and active CD11b will be made via an Accuri C6 flow cytometer using standard antibodies on an aliquot of whole blood.

  3. Measures of neutrophil metabolism (e.g. O2 consumption) [ Time Frame: 1 Day ]
    Metabolism of neutrophils will be measured using the Seahorse assay.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of age for the healthy volunteer subset.
  • 18 years of age and within 24 hours of an MI for the MI subset.

Exclusion Criteria:

Subjects in all 3 groups will be excluded if they meet one of the following criteria

  • history of myelodysplasia;
  • Use of anti-inflammatory medications, with the exception of aspirin, within 5 half-lives;
  • medications known to interact with colchicine;
  • known creatinine clearance <30 cc/minute (severe kidney disease);
  • pregnant; or
  • Unable to consent.

MI subjects who will have oral colchicine administered will have the following additional exclusion criteria:

  • history of intolerance to colchicine;
  • acute or chronic symptoms of diarrhea within 72 hours prior to enrollment;
  • hemoglobin <10 g/dL or clinical evidence of active bleeding during the study period.

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): NCT02995512


Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Binita Shah, MD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02995512    
Other Study ID Numbers: 16-01704
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
myocardial infarction
colchicine
anti-inflammatory
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents