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Completed

NCT Number: NCT02594111

Colchicine in 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.

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Key information

Conditions

Coronary Artery Disease Acute Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Inflammation Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

New York, 10010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colchicine vs Placebo

Drug

Colchicine vs Placebo 1.8 mg PO over 1 hour

Primary outcomes

  1. Number of Participants With Peri-procedural Myocardial Necrosis

    Time frame: 24 hours

    troponin above the upper limit of normal (ULN)

Secondary outcomes

  1. Number of Participants With All-cause Mortality, Non-fatal MI, or Target Vessel Revascularization (TVR)

    Time frame: 30 days

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

  2. Number of Participants With All-cause Mortality, Non-fatal MI, or TVR

    Time frame: 1 year

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

  3. All-cause Mortality, Non-fatal MI, or TVR

    Time frame: 2 years

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

  4. All-cause Mortality, Non-fatal MI, or TVR

    Time frame: 3 years

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

  5. All-cause Mortality, Non-fatal MI, or TVR

    Time frame: 4 years

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

  6. All-cause Mortality, Non-fatal MI, or TVR

    Time frame: 5 years

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

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

    Time frame: 24 hours

    SCAI definition

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • NYU Langone Health

Registry information

Official study title

Anti-inflammatory Therapy During Percutaneous Coronary Intervention

Acronym: Colchicine-PCI

Important dates

Study start
2013
Primary completion
2019
Study completion
2021
First posted
Nov 2, 2015
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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