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Colchicine in Percutaneous Coronary Intervention (Colchicine-PCI)

Primary Purpose

Coronary Artery Disease, Acute Coronary Syndrome

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Colchicine vs Placebo
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring inflammation, percutaneous coronary intervention, coronary artery disease, colchicine

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Colchicine

Placebo

Arm Description

Colchicine 1.8 mg PO over 1 hour

Matching placebo

Outcomes

Primary Outcome Measures

Number of Participants With Peri-procedural Myocardial Necrosis
troponin above the upper limit of normal (ULN)

Secondary Outcome Measures

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)
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)
All-cause Mortality, Non-fatal MI, or TVR
all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
All-cause Mortality, Non-fatal MI, or TVR
all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
All-cause Mortality, Non-fatal MI, or TVR
all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
All-cause Mortality, Non-fatal MI, or TVR
all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
Number of Participants With Peri-procedural Myocardial Infarction (MI)
SCAI definition

Full Information

First Posted
October 30, 2015
Last Updated
January 25, 2023
Sponsor
VA Office of Research and Development
Collaborators
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT02594111
Brief Title
Colchicine in Percutaneous Coronary Intervention
Acronym
Colchicine-PCI
Official Title
Anti-inflammatory Therapy During Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2013 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Acute Coronary Syndrome
Keywords
inflammation, percutaneous coronary intervention, coronary artery disease, colchicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
714 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colchicine
Arm Type
Active Comparator
Arm Description
Colchicine 1.8 mg PO over 1 hour
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
Colchicine vs Placebo
Intervention Description
Colchicine vs Placebo 1.8 mg PO over 1 hour
Primary Outcome Measure Information:
Title
Number of Participants With Peri-procedural Myocardial Necrosis
Description
troponin above the upper limit of normal (ULN)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Number of Participants With All-cause Mortality, Non-fatal MI, or Target Vessel Revascularization (TVR)
Description
all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
Time Frame
30 days
Title
Number of Participants With All-cause Mortality, Non-fatal MI, or TVR
Description
all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
Time Frame
1 year
Title
All-cause Mortality, Non-fatal MI, or TVR
Description
all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
Time Frame
2 years
Title
All-cause Mortality, Non-fatal MI, or TVR
Description
all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
Time Frame
3 years
Title
All-cause Mortality, Non-fatal MI, or TVR
Description
all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
Time Frame
4 years
Title
All-cause Mortality, Non-fatal MI, or TVR
Description
all-cause mortality, non-fatal MI (universal definition), or target vessel revascularization (TVR)
Time Frame
5 years
Title
Number of Participants With Peri-procedural Myocardial Infarction (MI)
Description
SCAI definition
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binita Shah, MD
Organizational Affiliation
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32295417
Citation
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.
Results Reference
derived

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Colchicine in Percutaneous Coronary Intervention

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