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Anti-inflammatory Effects of Colchicine in 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: NCT01709981
Recruitment Status : Active, not recruiting
First Posted : October 18, 2012
Last Update Posted : September 30, 2019
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Binita Shah, NYU Langone Health

Brief Summary:
Peri-procedural inflammation is associated with increased rates of post-procedural myocardial infarction (MI), which occur in up to 35% of PCI patients and are themselves associated with increased risk of later MI and death. Statins suppress both inflammatory markers and MI rates during and after PCI, but ≥ 40% of PCI patients go statin-untreated, due in part to side effects such as myalgia. Moreover, because their mechanism of action relies on post-translational effects, statins must be given ≥ 12 to 24 hours prior to PCI, a time frame that is not always feasible. The investigators propose a novel alternative approach to reduce inflammation during PCI employing colchicine, an anti-inflammatory medication used frequently in gout and pericarditis. Colchicine may be particularly applicable to the PCI setting due to its rapid onset of action and excellent side-effect profile at low doses, as well as its known mechanisms of action. However, data on colchicine use in patients with coronary disease is extremely limited, and no studies to date have evaluated the use of colchicine in patients undergoing PCI. The investigators aim to characterize a potential mechanism of benefit in patients undergoing PCI by evaluating the effects of colchicine on soluble and leukocyte surface markers after PCI. The investigators also aim to determine the effects of colchicine on peri-procedural myonecrosis and MI. Accordingly, the investigators propose a prospective randomized study to characterize the effect of colchicine on inflammation and peri-procedural myocnecrosis. Patients referred for possible PCI will be randomized in a double-blinded fashion to placebo or colchicine (1.2mg 1 to 2 hours before PCI, followed by 0.6mg 1 hour later). The primary endpoint will be post-procedural interleukin-6 level. Secondary endpoints will include other relevant soluble and leukocyte-associated inflammatory markers. Sample size needed is 200 patients undergoing PCI. To adjust for a floor effect, 280 patients undergoing PCI will be needed. 400 patients will likely be needed to be enrolled to reach 280 PCIs (the remaining will have undergone a diagnostic only procedure). Of note, this is a substudy of the COLCHICINE-PCI trial (NCT 02594111)

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 478 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anti-inflammatory Effects of Colchicine in Patients Undergoing Percutaneous Coronary Intervention: Inflammatory Marker Substudy of the Colchicine-PCI Trial
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
Experimental: Colchicine
1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later
Drug: Colchicine
Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later
Other Name: Colcrys

Placebo Comparator: Placebo
Placebo 1-2 hours prior PCI, followed by placebo 1 hour later
Drug: Placebo
Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later




Primary Outcome Measures :
  1. Post-procedural IL-6 concentration [ Time Frame: 30 minutes to 1 hour after PCI ]

Secondary Outcome Measures :
  1. Post-procedural mean fluorescence intensity of cell-associated L- selectin as measured by flow cytometry [ Time Frame: 30 minutes to 1 hour, 6 to 8 hours, and ~24 hours (next day morning collection) post-PCI ]
  2. Post-procedural mean fluorescence intensity of cell-associated beta-2 integrin as measured by flow cytometry [ Time Frame: 30 minutes to 1 hour, 6 to 8 hours, and ~24 hours (next day morning collection) post-PCI ]
  3. Post-procedural concentration of interleukin-1B [ Time Frame: 30 minutes to 1 hour, 6 to 8 hours, and ~24 hours (next day morning collection) post-PCI ]
  4. Post-procedural concentration of soluble E-selectin [ Time Frame: 30 minutes to 1 hour, 6 to 8 hours, and ~24 hours (next day morning collection) post-PCI ]
  5. Post-procedural concentration of soluble L-selectin [ Time Frame: 30 minutes to 1 hour, 6 to 8 hours, and ~24 hours (next day morning collection) post-PCI ]
  6. Post-procedural concentration of intercellular adhesion molecule-1 [ Time Frame: 30 minutes to 1 hour, 6 to 8 hours, and ~24 hours (next day morning collection) post-PCI ]
  7. Post-procedural concentration of vascular cell adhesion molecule [ Time Frame: 30 minutes to 1 hour, 6 to 8 hours, and ~24 hours (next day morning collection) post-PCI ]
  8. Post-procedural concentration of NGAL [ Time Frame: 30 minutes to 1 hour, 6 to 8 hours, and ~24 hours (next day morning collection) post-PCI ]
  9. Post-procedural concentration of MPO [ Time Frame: 30 minutes to 1 hour, 6 to 8 hours, and ~24 hours (next day morning collection) post-PCI ]
  10. Post-procedural concentration of neutrophil elastase [ Time Frame: 30 minutes to 1 hour, 6 to 8 hours, and ~24 hours (next day morning collection) post-PCI ]
  11. Post-procedural concentration of tumor necrosis factor-α [ Time Frame: 30 minutes to 1 hour, 6 to 8 hours, and ~24 hours (next day morning collection) post-PCI ]
  12. Post-procedural level of white blood cell count [ Time Frame: 30 minutes to 1 hour, 6 to 8 hours, and ~24 hours (next day morning collection) post-PCI ]
  13. Post-procedural peripheral neutrophil lymphocyte ratio [ Time Frame: 30 minutes to 1 hour, 6 to 8 hours, and ~24 hours (next day morning collection) post-PCI ]
  14. 30-day MACE [ Time Frame: 30 days ]
    all-cause mortality, non-fatal MI, and target vessel revascularizaiton



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be more than 18 years of age and referred for coronary angiography

Exclusion Criteria:

  • Plan for diagnostic-only coronary angiography
  • On colchicine chronically
  • History of intolerance to colchicine
  • Glomerular filtration rate <30mL/minute or on dialysis
  • Active malignancy or infection
  • History of myelodysplasia
  • High-dose statin load <24 hours prior to procedure
  • Use of oral steroids or non-steroidal anti-inflammatory agents other than aspirin within 72 hours or 3 times the agent's half-life (whichever is longer)
  • Use of strong CYP3A4/P-glycoprotein inhibitors (specifically ritonavir, ketoconazole, clarithromycin, cyclosporine, diltiazem and verapamil)
  • Unable to consent
  • Participating in a competing study

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): NCT01709981


Locations
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United States, New York
Manhattan VA Hospital
New York, New York, United States, 10010
Bellevue Hospital Center
New York, New York, United States, 10016
New York Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Takeda
Investigators
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Principal Investigator: Binita Shah, MD NYU Langone Health
  Study Documents (Full-Text)

Documents provided by Binita Shah, NYU Langone Health:
Statistical Analysis Plan  [PDF] August 7, 2019
Study Protocol  [PDF] August 7, 2019


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Responsible Party: Binita Shah, Assistant Professor of Medicine, NYU Langone Health
ClinicalTrials.gov Identifier: NCT01709981    
Other Study ID Numbers: 11-02573
First Posted: October 18, 2012    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Colchicine
Anti-Inflammatory Agents
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents