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CompletedNCT02594111Colchicine-PCIUpdated Feb 21, 2023Results posted

Colchicine in Percutaneous Coronary Intervention

A Phase 4 interventional study of Colchicine vs Placebo in Coronary Artery Disease and Acute Coronary Syndrome, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-02-21.

Sponsored by VA Office of Research and Development · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled May 2013, registered Oct 2015).
Phase
Phase 4
Study type
Interventional
Enrollment
714
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronary Artery Disease
  • Acute Coronary Syndrome

Keywords

  • inflammation
  • percutaneous coronary intervention
  • coronary artery disease
  • colchicine
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 714 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Referred for possible PCI

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
714 participants (actual)

Study arms

  • Active comparator
    Colchicine

    Colchicine 1.8 mg PO over 1 hour

    Drug: Colchicine vs Placebo

  • Placebo comparator
    Placebo

    Matching placebo

    Drug: Colchicine vs Placebo

Interventions

  • DrugColchicine vs Placebo

    Colchicine vs Placebo 1.8 mg PO over 1 hour

06

What researchers measure

Primary outcomes

  1. Number of Participants With Peri-procedural Myocardial Necrosis

    troponin above the upper limit of normal (ULN)

    Time frame: 24 hours

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

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

    SCAI definition

    Time frame: 24 hours

07

Results

Posted Jul 10, 2020

Participant flow

Participant flow — Overall Study
MilestoneColchicinePlacebo
Started366348
Completed366348
Not completed00

Outcome measures

PrimaryNumber of Participants With Peri-procedural Myocardial Necrosis

troponin above the upper limit of normal (ULN)

Time frame:
24 hours
Reported as:
Count of participants · Participants
Number of Participants With Peri-procedural Myocardial Necrosis
ParticipantsColchicinePlacebo
Number of Participants With Peri-procedural Myocardial Necrosis118122
Statistical analysis
  • Colchicine vs Placebo · Chi-squared · p = <0.05
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With All-cause Mortality, Non-fatal MI, or Target Vessel Revascularization (TVR)
ParticipantsColchicinePlacebo
Number of Participants With All-cause Mortality, Non-fatal MI, or Target Vessel Revascularization (TVR)2325
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With All-cause Mortality, Non-fatal MI, or TVR
ParticipantsColchicinePlacebo
Number of Participants With All-cause Mortality, Non-fatal MI, or TVR3536
SecondaryAll-cause Mortality, Non-fatal MI, or TVR

all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)

Time frame:
2 years
Reported as:
Count of participants · Participants
All-cause Mortality, Non-fatal MI, or TVR
ParticipantsColchicinePlacebo
All-cause Mortality, Non-fatal MI, or TVR4848
SecondaryAll-cause Mortality, Non-fatal MI, or TVR

all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)

Time frame:
3 years
Reported as:
Count of participants · Participants
All-cause Mortality, Non-fatal MI, or TVR
ParticipantsColchicinePlacebo
All-cause Mortality, Non-fatal MI, or TVR5757
SecondaryAll-cause Mortality, Non-fatal MI, or TVR

all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)

Time frame:
4 years
Reported as:
Count of participants · Participants
All-cause Mortality, Non-fatal MI, or TVR
ParticipantsColchicinePlacebo
All-cause Mortality, Non-fatal MI, or TVR6563
SecondaryAll-cause Mortality, Non-fatal MI, or TVR

all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)

Time frame:
5 years
Reported as:
Count of participants · Participants
All-cause Mortality, Non-fatal MI, or TVR
ParticipantsColchicinePlacebo
All-cause Mortality, Non-fatal MI, or TVR6767
SecondaryNumber of Participants With Peri-procedural Myocardial Infarction (MI)

SCAI definition

Time frame:
24 hours
Reported as:
Count of participants · Participants
Number of Participants With Peri-procedural Myocardial Infarction (MI)
ParticipantsColchicinePlacebo
Number of Participants With Peri-procedural Myocardial Infarction (MI)69

Adverse events

Collected over For those who underwent diagnostic coronary angiogram only (n=314): 24 hours For those who underwent percutaneous coronary intervention (n=400), all AEs other than death, myocardial infarction, and target vessel revascularization: 30 days For those who underwent percutaneous coronary intervention (n=400), death, myocardial infarction, and target vessel revascularization: at least 2 years but up to 5 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Colchicine26/206 (12.6%)72/366 (19.7%)67/366 (18.3%)
Placebo29/194 (14.9%)79/348 (22.7%)36/348 (10.3%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventColchicinePlacebo
all-cause mortalityCardiac disorders26/20629/194
PCI-related myocardial infarctionCardiac disorders23/20623/194
myocardial infarctionCardiac disorders18/20619/194
target vessel revascularizationCardiac disorders16/20614/194
Chest painCardiac disorders1/3662/348
Hemodynamic instabilityGeneral disorders0/3662/348
FeverImmune system disorders0/3662/348
Elevated creatinineRenal and urinary disorders1/3662/348
BleedingGeneral disorders0/3662/348
Access site discomfortInjury, poisoning and procedural complications0/3661/348
Most frequent other events
Most frequent other events
EventColchicinePlacebo
Gastrointestinal symptomsGastrointestinal disorders34/36611/348
Chest painCardiac disorders33/36625/348

Baseline characteristics

Age, Continuous
Age, Continuous(years)ColchicinePlaceboTotal
Mean66.1 ± 9.765.8 ± 10.765.9 ± 10.2
Sex: Female, Male
Sex: Female, Male(Participants)ColchicinePlaceboTotal
Female302454
Male336324660
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)ColchicinePlaceboTotal
Hispanic or Latino7579154
Not Hispanic or Latino291269560
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)ColchicinePlaceboTotal
American Indian or Alaska Native000
Asian111930
Native Hawaiian or Other Pacific Islander000
Black or African American8575160
White268253521
More than one race000
Unknown or Not Reported213
Region of Enrollment
Region of Enrollment(Participants)ColchicinePlaceboTotal
United States366348714
08

Study locations

1 site
  • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
    New York, New York 10010, United States
09

References and documents

Publications

  • Shah B, Pillinger M, Zhong H, Cronstein B, Xia Y, Lorin JD, Smilowitz NR, Feit F, Ratnapala N, Keller NM, Katz SD. Effects of Acute Colchicine Administration Prior to Percutaneous Coronary Intervention: COLCHICINE-PCI Randomized Trial. Circ Cardiovasc Interv. 2020 Apr;13(4):e008717. doi: 10.1161/CIRCINTERVENTIONS.119.008717. Epub 2020 Apr 16. PubMed 32295417 ↗

Study documents

  • Study protocol · Aug 7, 2019
  • Statistical analysis plan · Aug 7, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02594111
Lead sponsor
VA Office of Research and Development
Collaborators
NYU Langone Health
Responsible party
Sponsor
First posted
Nov 1, 2015
Start date
May 30, 2013
Primary completion
Aug 30, 2019
Completion
Dec 31, 2021
Results posted
Jul 10, 2020
Last update
Feb 21, 2023

Study contacts

Binita Shah, MD
principal investigator · Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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