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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
714
Colchicine vs Placebo 1.8 mg PO over 1 hour
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, United States
Number of Participants With Peri-procedural Myocardial Necrosis
troponin above the upper limit of normal (ULN)
Time frame: 24 hours
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)
Time frame: 30 days
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)
Time frame: 1 year
All-cause Mortality, Non-fatal MI, or TVR
all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
Time frame: 2 years
All-cause Mortality, Non-fatal MI, or TVR
all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
Time frame: 3 years
All-cause Mortality, Non-fatal MI, or TVR
all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
Time frame: 4 years
All-cause Mortality, Non-fatal MI, or TVR
all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
Time frame: 5 years
Number of Participants With Peri-procedural Myocardial Infarction (MI)
SCAI definition
Time frame: 24 hours
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