Mechanistic Effects of Colchicine in Patients With Myocardial Infarction

NCT02995512 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 16-01704
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myocardial Infarction

Keywords

myocardial infarction; colchicine; anti-inflammatory

Outcome Measures

Primary Outcomes (1)

• Number of neutrophils adherent to TNFα-stimulated endothelial cells

  Metabolism of neutrophils will be measured using the Seahorse assay.

  1 Day

Secondary Outcomes (3)

• Levels of adhesion molecules on neutrophils and endothelial cells quantified using PCR

  1 Day

• Expression of adhesion molecules on the surface of neutrophils assessed via flow cytometry

  1 Day

• Measures of neutrophil metabolism (e.g. O2 consumption)

  1 Day

Study Arms (1)

Myocardial Infarction (MI) Patients

EXPERIMENTAL

Drug: Colchicine 0.6 mg tablets

Interventions

Colchicine 0.6 mg tablets DRUG

1.2 mg PO followed by 0.6 mg PO 1 hour later

Myocardial Infarction (MI) Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Binita Shah, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 16, 2016
• Study Start: May 1, 2017
• Primary Completion: September 12, 2018
• Study Completion: September 12, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04