Colchicine in Percutaneous Coronary Intervention

• Status: Active, not recruiting
• Trial end date: 2024-08-30
• Target enrollment: 0
• Participant gender: All

Summary

Inflammation in the arteries of the heart may increase the risk of cardiac death. The proposed research seeks to identify the potential beneficial role of a safe anti-inflammatory medication, colchicine, on reducing damage caused by opening up a blockage in the arteries of the heart. With its quick onset of action and excellent safety profile, colchicine may have the potential to reduce risk of major adverse events related to the heart. This research also seeks to better understand the role of neutrophils, the most common type of inflammatory white blood cell in the body, when there is damage to the heart.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Collaborators: New York University School of Medicine; NYU Langone Health
• Treatments: Colchicine

Criteria

Inclusion Criteria:

• Referred for possible PCI

Exclusion Criteria:

• Colchicine use within 1 month

• History of colchicine intolerance

• Glomerular filtration rate <30mL/minute or on dialysis (due to the need to adjust colchicine dose in this setting)

• Active malignancy or infection (major confounder with increased inflammatory markers)

• History of myelodysplasia (due to suggested cautionary use of colchicine in this setting)

• High-dose statin load <24 hours prior to procedure (major confounder that is known to reduce inflammatory levels in 12 to 24 hours)

• Use of anti-inflammatory agents (except aspirin) within 5 halflives of the individual drug

• Use of strong Cytochrome P450, Family 3, Subfamily A, Polypeptide 4 (CYP3A4) and/or P-glycoprotein inhibitors (e.g. ritonavir, ketoconazole, clarithromycin, cyclosporine, diltiazem and verapamil, again due to drug interactions)

• Unable to consent

• Participating in a competing study

• Any significant condition or situation that may put the subject at higher risk, confound the study results or interfere with adherence to study procedures