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Anti-inflammatory Therapy During Percutaneous Coronary Intervention
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.
Age
18 - 99 years
Sex
ALL
Healthy Volunteers
No
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, United States
Start Date
May 30, 2013
Primary Completion Date
August 30, 2019
Completion Date
December 31, 2021
Last Updated
February 21, 2023
714
ACTUAL participants
Colchicine vs Placebo
DRUG
Lead Sponsor
VA Office of Research and Development
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07436429