Colchicine in Percutaneous Coronary Intervention

Phase 4

Completed

• Conditions: Coronary Artery Disease; Acute Coronary Syndrome
• Interventions: Drug: Colchicine vs Placebo

• Registration Number: NCT02594111
• Lead Sponsor: VA Office of Research and Development

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-05-30
• Study First Submitted: 2015-10-30
• Study First Submitted QC: 2015-10-30
• Study First Posted: 2015-11-01
• Primary Completion: 2019-08-30
• Results First Submitted: 2020-06-08
• Results First Submitted QC: 2020-06-26
• Results First Posted: 2020-07-10
• Study Completion: 2021-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 714

Inclusion Criteria

• Referred for possible PCI

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colchicine	Colchicine vs Placebo	Colchicine 1.8 mg PO over 1 hour
Placebo	Colchicine vs Placebo	Matching placebo

Primary Outcome Measures

Name	Time	Method
Number of Participants With Peri-procedural Myocardial Necrosis	24 hours	troponin above the upper limit of normal (ULN)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With All-cause Mortality, Non-fatal MI, or TVR	1 year	all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
All-cause Mortality, Non-fatal MI, or TVR	5 years	all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
Number of Participants With Peri-procedural Myocardial Infarction (MI)	24 hours	SCAI definition
Number of Participants With All-cause Mortality, Non-fatal MI, or Target Vessel Revascularization (TVR)	30 days	all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)

Trial Locations

Locations (1)

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY; 🇺🇸 New York, New York, United States