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Colchicine in Percutaneous Coronary Intervention (Colchicine-PCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02594111
Recruitment Status : Active, not recruiting
First Posted : November 2, 2015
Last Update Posted : October 7, 2019
Sponsor:
Collaborator:
NYU Langone Health
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Acute Coronary Syndrome Drug: Colchicine vs Placebo Phase 4

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.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 714 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anti-inflammatory Therapy During Percutaneous Coronary Intervention
Actual Study Start Date : May 30, 2013
Actual Primary Completion Date : August 30, 2019
Estimated Study Completion Date : August 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arm Intervention/treatment
Active Comparator: Colchicine
Colchicine 1.8 mg PO over 1 hour
Drug: Colchicine vs Placebo
Colchicine vs Placebo 1.8 mg PO over 1 hour

Placebo Comparator: Placebo
Matching placebo
Drug: Colchicine vs Placebo
Colchicine vs Placebo 1.8 mg PO over 1 hour




Primary Outcome Measures :
  1. Peri-procedural myocardial necrosis [ Time Frame: 24 hours ]
    troponin above the ULN


Secondary Outcome Measures :
  1. 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. 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. Peri-procedural myocardial infarction (MI) [ Time Frame: 24 hours ]
    SCAI definition



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594111


Locations
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United States, New York
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, United States, 10010
Sponsors and Collaborators
VA Office of Research and Development
NYU Langone Health
Investigators
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Principal Investigator: Binita Shah, MD Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Study Protocol  [PDF] August 7, 2019
Statistical Analysis Plan  [PDF] August 7, 2019


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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02594111     History of Changes
Other Study ID Numbers: CARB-025-15S
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
inflammation
percutaneous coronary intervention
coronary artery disease
colchicine
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents