Colchicine in Percutaneous Coronary Intervention (Colchicine-PCI)

VA Office of Research and Development

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease; Acute Coronary Syndrome

Treatments: Drug: Colchicine vs Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02594111

CARB-025-15S

Details and patient eligibility

About

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.

Full description

The investigators will use colchicine as a tool to elucidate the role of neutrophil activation during acute vascular injury, and to explore the association between neutrophil activation and adverse cardiovascular outcomes. Colchicine reduces cell surface expression of selections, adhesion molecules key to neutrophil recruitment after vascular injury. Daily colchicine use is associated with reduced adverse cardiovascular events in stable atherosclerosis. Using a clinical percutaneous coronary intervention (PCI) model, the investigators evaluate whether pre-procedural colchicine (1.8 mg oral load over one hour) reduces the rate of post-PCI adverse cardiovascular outcomes in the context of a double-blind placebo-controlled randomized study. The investigators will also characterize neutrophil biology in acute vascular injury and the effects of colchicine on neutrophil biology in this setting.

Enrollment: 714 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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714 participants in 2 patient groups, including a placebo group

Colchicine

Active Comparator group

Description:

Colchicine 1.8 mg PO over 1 hour

Treatment:

Drug: Colchicine vs Placebo

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Colchicine vs Placebo