Colchicine in Percutaneous Coronary Intervention
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 3/30/2019 |
| Start Date: | June 3, 2013 |
| End Date: | December 31, 2020 |
| Contact: | Binita Shah, MD |
| Email: | Binita.Shah@va.gov |
| Phone: | (212) 686-7500 |
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.
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.
This study will extend the investigations from study NCT01709981 on ClinicalTrials.gov, which
remains double-blinded. However, while the main focus of study NCT01709981 is to evaluate
markers of inflammation, the current study's main focus will be to evaluate peri-procedural
myocardial infarction. Although recruitment for the current study will begin in 12/2015, the
investigators will increase power by using data already collected in from the initial
substudy NCT01709981.
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.
This study will extend the investigations from study NCT01709981 on ClinicalTrials.gov, which
remains double-blinded. However, while the main focus of study NCT01709981 is to evaluate
markers of inflammation, the current study's main focus will be to evaluate peri-procedural
myocardial infarction. Although recruitment for the current study will begin in 12/2015, the
investigators will increase power by using data already collected in from the initial
substudy NCT01709981.
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
We found this trial at
1
site
New York, New York 10010
Principal Investigator: Binita Shah, MD
Phone: 212-686-7500
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