Anti-inflammatory Effects of Colchicine in PCI

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by New York University School of Medicine
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Steven Sedlis, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01709981
First received: October 16, 2012
Last updated: February 19, 2014
Last verified: February 2014

October 16, 2012
February 19, 2014
June 2013
December 2015   (final data collection date for primary outcome measure)
Post-procedural IL-6 level [ Time Frame: 30 minutes to 1 hour after PCI ] [ Designated as safety issue: No ]
Post-procedural IL-6 level [ Time Frame: Within 30 minutes after PCI ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01709981 on ClinicalTrials.gov Archive Site
  • Other relevant inflammatory markers [ Time Frame: 30 minutes to 1 hour, 6 to 8 hours, and ~24 hours (next day morning collection) post-PCI ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    all-cause mortality, non-fatal MI, and target vessel revascularizaiton
  • post-procedural myonecrosis [ Time Frame: 6 to 8 hours and ~24 hours post-PCI ] [ Designated as safety issue: No ]
  • Other relevant inflammatory markers [ Time Frame: 30 minutes, 6 to 8 hours, and 12 to 16 hours post-PCI ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Anti-inflammatory Effects of Colchicine in PCI
Anti-inflammatory Effects of Colchicine in Patients Undergoing Percutaneous Coronary Intervention

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 and rates of peri-procedural myonecrosis and MI. Sample size needed is 200 patients undergoing PCI. 400 patients will likely be needed to be enrolled to reach 200 PCIs given that no more than 50% of patients enrolled may undergo diagnostic only procedure (without PCI).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Coronary Artery Disease
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
January 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Steven P Sedlis, MD 2129513335 steven.sedlis@nyumc.org
Contact: Binita Shah, MD, MS 2122635656 binita.shah@nyumc.org
United States
 
NCT01709981
11-02573
Not Provided
Steven Sedlis, New York University School of Medicine
New York University School of Medicine
Takeda
Principal Investigator: Steven P Sedlis, MD New York University School of Medicine
Principal Investigator: Binita Shah, MD, MS New York University School of Medicine
New York University School of Medicine
February 2014

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