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Colchicine Prevents Myocardial Injury After Non-Cardiac Surgery Pilot Study (COPMAN)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04139655
Recruitment Status : Not yet recruiting
First Posted : October 25, 2019
Last Update Posted : October 25, 2019
Sponsor:
Collaborators:
Providence Health & Services
Vancouver Coastal Health
Information provided by (Responsible Party):
Ron Ree, University of British Columbia

Brief Summary:

Perioperative Myocardial Infarction (PMI) is a major contributor to perioperative mortality and morbidity with overall incidence of 5-16% (1, 2). It is associated with increased 30-day mortality of 11.6% vs 2.2% of patients without PMI in non-cardiac surgical patients (1). However, its recognition and diagnosis remains challenging as the typical symptoms and findings of ischemic MI may be masked by post-operative changes and pain management.

In this study, the investigators hope to determine if colchicine decreases the incidence of MINS in high risk surgical patients undergoing non-cardiac surgery and optimally establish colchicine as a viable therapy to improve perioperative cardiovascular outcome in those patients.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Myocardial Injury Major Adverse Cardiac Events Infectious Complications Drug: Colchicine 0.6 mg Drug: Placebo oral tablet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Control Pilot Study
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-Blinded
Primary Purpose: Prevention
Official Title: Colchicine Prevents Myocardial Injury After Non-Cardiac Surgery Pilot Study (COPMAN)
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arm Intervention/treatment
Experimental: Intervention Group
Administration of oral colchicine at 0.6 mg 1 hour prior to surgery, then 0.6 mg twice daily starting on the night after surgery for 7 days or until discharge from hospital, whichever occurs earlier. For patient under 60kg in body weight, daily dose will be 0.6 mg once daily. Medical and surgical management of the participant will be carried out under each institute's standard clinical practice.
Drug: Colchicine 0.6 mg
Oral colchicine given at 0.6 mg 1 hour prior to surgery, then 0.6 mg twice daily starting on the night after surgery for 7 days or until discharge from hospital, whichever occurs earlier. For patient under 60kg in body weight, daily dose will be 0.6 mg once daily. Medical and surgical management of the participant will be carried out under each institute's standard clinical practice.

Placebo Comparator: Control Group
Participants allocated to the control group will receive a placebo pill at the same dosing regimen as with treatment group. Perioperative and surgical care will not be different from standard clinical practice.
Drug: Placebo oral tablet
Placebo oral tablet given at 0.6 mg 1 hour prior to surgery, then 0.6 mg twice daily starting on the night after surgery for 7 days or until discharge from hospital, whichever occurs earlier. For patient under 60kg in body weight, daily dose will be 0.6 mg once daily. Medical and surgical management of the participant will be carried out under each institute's standard clinical practice.




Primary Outcome Measures :
  1. Number of Patients Recruited [ Time Frame: 3 months ]
    The number of eligible subjects recruited in 3 months after 2 weeks of run-in period in participating centres


Secondary Outcome Measures :
  1. Incidence of Myocardial Injury after Non-Cardiac Surgery (MINS) [ Time Frame: From Post-Operatively day one up to 7 days post-operatively ]
    The incidence of MINS in the treatment versus placebo group, as defined by high sensitivity troponin T level > 65 ng/L or Troponin level > 0.03 ng/mL. The incidence of MINS will be determined upon review of the troponin assay on post-operative day 0, 1, 2 and 3rd (or according to each participating institution's own MINS pathway) and electroncardiogram (ECG) on post-operative day 1, or as otherwise clinically indicated and ordered by the perioperative team. Information will be obtained by review of blood work results and ECG on institution's electronic health record and patient's bedside chart if necessary by our research team member.

  2. Adverse Events [ Time Frame: Duration of hospital admission up to 7 days post-operatively ]
    We will collect adverse effects, whether or not associated with study drug through review of patient's bedside chart and discharge summary.

  3. Incidence of premature discontinuation of the study drug and Reasoning [ Time Frame: Post-Operatively until date of study drug discontinuation (up to 7 days post-operatively) ]
    Incidence of premature discontinuation of the study drug will be recorded. If the subject chooses to discontinue the study drug and withdraw from the study, the duration of treatment before withdraw as well as reasons of withdraw will be recorded.

  4. Incidence of infectious complications [ Time Frame: Duration of hospital admission up to 7 days post-operatively ]
    Incidence of infectious complications will also be recorded with review of chart and discharge summary. The determination of the complication will depend on patient's chart review, history and physical assessment by the primary care provider team, and associated imaging and laboratory investigations as clinically indicated. Complications include, but are not limited to: including but not limited to: pneumonia, surgical site infection, urinary tract infection, and sepsis during the hospital admission.


Other Outcome Measures:
  1. Medical comorbidities [ Time Frame: Duration of hospital admission up to 7 days post-operatively ]
    Based on patient charts.

  2. Clinical risk stratification scores [ Time Frame: Duration of hospital admission up to 7 days post-operatively ]
    Revised cardiac risk index - RCRI scores based on patient charts.RCRI score is used and recommended by Canadian Cardiovascular Society as an evidence-based 30-day perioperative cardiovascular mortality and morbidity risk stratification tool

  3. Neutrophil to lymphocyte ratio (NLR) [ Time Frame: Pre-operatively up to 7 days post-operatively ]
    Based on patient charts, to be obtained from patient's pre-operative bloodwork. NLR is a marker of neutrophil predominant inflammatory state that is associated with Major Adverse Cardiac Events (MACE) in a systemic review



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Any patient undergoing non-cardiac surgery is eligible if (s)he is:

  • Aged 45 years of age or older
  • Expected to be admitted for >48 hours
  • Have a preoperative BNP value of 92 or higher, or a NT-proBNP value of 300 or higher,
  • If a BNP or NT-proBNP is not available, then the patient must fulfill at least one of the criteria for moderate to high risk of perioperative myocardial injury (see below):

Moderate to high risk for perioperative myocardial injury criteria:

  • History of coronary artery disease
  • History of peripheral artery disease
  • History of stroke
  • Undergoing major vascular surgery
  • Any 3 of the following 9 criteria:

    1. Age 70 years or greater
    2. Undergoing intraperitoneal, retroperitoneal, intrathoracic, or major orthopaedic surgery
    3. History of heart failure
    4. History of transient ischemic attack
    5. History of diabetes requiring insulin or oral hypoglycemic medications
    6. Hypertension
    7. Serum creatinine greater than 170 mmol/mL
    8. History of smoking within 2 years of surgery
    9. Undergoing urgent or emergent surgery

Exclusion Criteria:

Patients will be ineligible for the study if (s)he has:

  • An allergy to colchicine
  • Myelodysplastic syndrome
  • An estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73m2
  • Anticipated post-operative administration of cyclosporine, ketoconazole, itraconazole, protease inhibitors, or clarithromycin

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): NCT04139655


Contacts
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Contact: Steven Wang, MD (604) 806-8337 skhwang@alumni.ubc.ca
Contact: Nicola Y Edwards, BHSc 778-870-5520 nedwards@providencehealth.bc.ca

Locations
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Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Nicola Y Edwards, BHSc    778-870-5520    nedwards@providencehealth.bc.ca   
Sub-Investigator: Cynthia Yarnold, MD FRCPC         
Sub-Investigator: Christopher Prabhakar, MD FRCPC         
Sub-Investigator: Nicola Edwards, BHSc         
Sub-Investigator: Steven Wang, MD         
Sponsors and Collaborators
University of British Columbia
Providence Health & Services
Vancouver Coastal Health
Investigators
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Principal Investigator: Ron Ree, MD Providence Health Care and UBC
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Responsible Party: Ron Ree, Clinical Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT04139655    
Other Study ID Numbers: H19-02858
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: October 25, 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: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ron Ree, University of British Columbia:
MINS
Colchicine
Myocardial Injury
Major Adverse Cardiac Events
Myocardial Injury after Non-Cardiac Surgery
MACE
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Wounds and Injuries
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents