Colchicine in Percutaneous Coronary Intervention

Coronary Artery Disease Clinical Trial

— Colchicine-PCI  

Official title:

Anti-inflammatory Therapy During Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594111
• Other study ID #: CARB-025-15S
• Status: Completed
• Phase: Phase 4
• Start date: May 30, 2013
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 714
• Est. completion date: December 31, 2021
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Colchicine vs Placebo
Colchicine vs Placebo 1.8 mg PO over 1 hour

Locations

Country	Name	City	State
United States	Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Peri-procedural Myocardial Necrosis	troponin above the upper limit of normal (ULN)	24 hours
Secondary	Number of Participants With All-cause Mortality, Non-fatal MI, or Target Vessel Revascularization (TVR)	all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)	30 days
Secondary	Number of Participants With All-cause Mortality, Non-fatal MI, or TVR	all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)	1 year
Secondary	All-cause Mortality, Non-fatal MI, or TVR	all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)	2 years
Secondary	All-cause Mortality, Non-fatal MI, or TVR	all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)	3 years
Secondary	All-cause Mortality, Non-fatal MI, or TVR	all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)	4 years
Secondary	All-cause Mortality, Non-fatal MI, or TVR	all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)	5 years
Secondary	Number of Participants With Peri-procedural Myocardial Infarction (MI)	SCAI definition	24 hours