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Colchicine in Percutaneous Coronary Intervention

Anti-inflammatory Therapy During Percutaneous Coronary Intervention

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02594111
Acronym
Colchicine-PCI
Enrollment
714
Registered
2015-11-02
Start date
2013-05-30
Completion date
2021-12-31
Last updated
2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Coronary Artery Disease

Keywords

inflammation, percutaneous coronary intervention, coronary artery disease, colchicine

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.

Interventions

DRUGColchicine vs Placebo

Colchicine vs Placebo 1.8 mg PO over 1 hour

Sponsors

NYU Langone Health
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Peri-procedural Myocardial Necrosis24 hourstroponin above the upper limit of normal (ULN)

Secondary

MeasureTime frameDescription
Number of Participants With All-cause Mortality, Non-fatal MI, or Target Vessel Revascularization (TVR)30 daysall-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
Number of Participants With All-cause Mortality, Non-fatal MI, or TVR1 yearall-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
All-cause Mortality, Non-fatal MI, or TVR2 yearsall-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
Number of Participants With Peri-procedural Myocardial Infarction (MI)24 hoursSCAI definition

Countries

United States

Participant flow

Participants by arm

ArmCount
Colchicine
Colchicine 1.8 mg PO over 1 hour Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour
366
Placebo
Matching placebo Colchicine vs Placebo: Colchicine vs Placebo 1.8 mg PO over 1 hour
348
Total714

Baseline characteristics

CharacteristicColchicineTotalPlacebo
Age, Continuous66.1 years
STANDARD_DEVIATION 9.7
65.9 years
STANDARD_DEVIATION 10.2
65.8 years
STANDARD_DEVIATION 10.7
Ethnicity (NIH/OMB)
Hispanic or Latino
75 Participants154 Participants79 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
291 Participants560 Participants269 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
11 Participants30 Participants19 Participants
Race (NIH/OMB)
Black or African American
85 Participants160 Participants75 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants3 Participants1 Participants
Race (NIH/OMB)
White
268 Participants521 Participants253 Participants
Region of Enrollment
United States
366 Participants714 Participants348 Participants
Sex: Female, Male
Female
30 Participants54 Participants24 Participants
Sex: Female, Male
Male
336 Participants660 Participants324 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
26 / 20629 / 194
other
Total, other adverse events
67 / 36636 / 348
serious
Total, serious adverse events
72 / 36679 / 348

Outcome results

Primary

Number of Participants With Peri-procedural Myocardial Necrosis

troponin above the upper limit of normal (ULN)

Time frame: 24 hours

Population: Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ColchicineNumber of Participants With Peri-procedural Myocardial Necrosis118 Participants
PlaceboNumber of Participants With Peri-procedural Myocardial Necrosis122 Participants
p-value: <0.05Chi-squared
Secondary

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

Population: Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ColchicineAll-cause Mortality, Non-fatal MI, or TVR67 Participants
PlaceboAll-cause Mortality, Non-fatal MI, or TVR67 Participants
Secondary

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

Population: Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ColchicineAll-cause Mortality, Non-fatal MI, or TVR48 Participants
PlaceboAll-cause Mortality, Non-fatal MI, or TVR48 Participants
Secondary

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

Population: Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ColchicineAll-cause Mortality, Non-fatal MI, or TVR57 Participants
PlaceboAll-cause Mortality, Non-fatal MI, or TVR57 Participants
Secondary

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

Population: Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ColchicineAll-cause Mortality, Non-fatal MI, or TVR65 Participants
PlaceboAll-cause Mortality, Non-fatal MI, or TVR63 Participants
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)

Time frame: 30 days

Population: Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ColchicineNumber of Participants With All-cause Mortality, Non-fatal MI, or Target Vessel Revascularization (TVR)23 Participants
PlaceboNumber of Participants With All-cause Mortality, Non-fatal MI, or Target Vessel Revascularization (TVR)25 Participants
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)

Time frame: 1 year

Population: Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ColchicineNumber of Participants With All-cause Mortality, Non-fatal MI, or TVR35 Participants
PlaceboNumber of Participants With All-cause Mortality, Non-fatal MI, or TVR36 Participants
Secondary

Number of Participants With Peri-procedural Myocardial Infarction (MI)

SCAI definition

Time frame: 24 hours

Population: Although 714 patients had baseline measure, were randomized to colchicine or placebo, and underwent coronary angiography, but of these, 400 patients went on to stent placement and had primary outcome measured (as per protocol)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ColchicineNumber of Participants With Peri-procedural Myocardial Infarction (MI)6 Participants
PlaceboNumber of Participants With Peri-procedural Myocardial Infarction (MI)9 Participants

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026