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Anti-inflammatory Effects of Colchicine in PCI

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ClinicalTrials.gov Identifier: NCT01709981
Recruitment Status : Completed
First Posted : October 18, 2012
Results First Posted : September 9, 2020
Last Update Posted : May 25, 2022
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 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
Actual Study Completion Date : December 13, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change in Post-procedural IL-6 Concentration From Baseline to 30 Min -1 hr After PCI [ Time Frame: 30 minutes to 1 hour after PCI ]

Secondary Outcome Measures :
  1. Percent Change in Post-procedural IL-6 Concentration From Baseline to 22-24 hr After PCI [ Time Frame: baseline to 22-24 hr after PCI ]
  2. Percent Change in Post-procedural hsCRP Concentration From Baseline to 22-24 hr After PCI [ Time Frame: baseline to 22-24 hr after PCI ]
  3. Percent Change in Post-procedural IL-1B Concentration From Baseline to 30 Min -1 hr After PCI [ Time Frame: 30 minutes to 1 hour after PCI ]
  4. Percent Change in Post-procedural IL-1B Concentration From Baseline to 30 Min -1 hr After PCI [ Time Frame: baseline to 22-24 hr after PCI ]

Eligibility Criteria
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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
Contacts and Locations
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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 NYU Langone Health:
Study Protocol  [PDF] August 7, 2019
Statistical Analysis Plan  [PDF] August 7, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01709981    
Other Study ID Numbers: 11-02573
First Posted: October 18, 2012    Key Record Dates
Results First Posted: September 9, 2020
Last Update Posted: May 25, 2022
Last Verified: May 2022
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
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents