Mechanistic Effects of Colchicine in Patients With Myocardial Infarction

• Status: Withdrawn
• Trial end date: 2018-09-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Treatments: Colchicine

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.