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Anti-inflammatory Effects of Colchicine in PCI

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ClinicalTrials.gov Identifier: NCT01709981
Recruitment Status : Active, not recruiting
First Posted : October 18, 2012
Results First Posted : September 9, 2020
Last Update Posted : July 1, 2021
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Binita Shah, NYU Langone Health

Tracking Information
First Submitted Date  ICMJE October 16, 2012
First Posted Date  ICMJE October 18, 2012
Results First Submitted Date  ICMJE July 23, 2020
Results First Posted Date  ICMJE September 9, 2020
Last Update Posted Date July 1, 2021
Actual Study Start Date  ICMJE May 30, 2013
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2020)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2012)
Post-procedural IL-6 level [ Time Frame: Within 30 minutes after PCI ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2020)
  • 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 ]
  • Percent Change in Post-procedural hsCRP Concentration From Baseline to 22-24 hr After PCI [ Time Frame: baseline to 22-24 hr after PCI ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2012)
  • Other relevant inflammatory markers [ Time Frame: 30 minutes, 6 to 8 hours, and 12 to 16 hours post-PCI ]
    cell-associated L- selectin, cell-associated beta-2 integrin, interleukin-1 receptor antagonist, soluble E- selectin, intercellular cell adhesion molecule-1, pentraxin 3, CCL-21, CXCL-16, tumor necrosis factor-α, white blood cell count, and neutrophil count
  • 30-day MACE [ Time Frame: 30 days ]
    all-cause mortality, non-fatal MI, and target vessel revascularizaiton
  • post-procedural myonecrosis [ Time Frame: 6 to 8 hours and 12 to 16 hours post-PCI ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anti-inflammatory Effects of Colchicine in PCI
Official Title  ICMJE Anti-inflammatory Effects of Colchicine in Patients Undergoing Percutaneous Coronary Intervention: Inflammatory Marker Substudy of the Colchicine-PCI Trial
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Drug: Colchicine
    Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later
    Other Name: Colcrys
  • Drug: Placebo
    Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later
Study Arms  ICMJE
  • Experimental: Colchicine
    1.2mg colchicine 1 to 2 hours prior PCI, followed by 0.6mg one hour later
    Intervention: Drug: Colchicine
  • Placebo Comparator: Placebo
    Placebo 1-2 hours prior PCI, followed by placebo 1 hour later
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 26, 2020)
280
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2012)
400
Estimated Study Completion Date  ICMJE August 20, 2022
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01709981
Other Study ID Numbers  ICMJE 11-02573
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Binita Shah, NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Takeda
Investigators  ICMJE
Principal Investigator: Binita Shah, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP