Colchicine Prevents Myocardial Injury After Non-Cardiac Surgery Pilot Study (COPMAN)
Myocardial Infarction, Myocardial Injury, Major Adverse Cardiac Events
About this trial
This is an interventional prevention trial for Myocardial Infarction focused on measuring MINS, Colchicine, Myocardial Injury, Major Adverse Cardiac Events, Myocardial Injury after Non-Cardiac Surgery, MACE
Eligibility 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 Brain natriuretic peptide (BNP) value of 92 or higher, or a N-terminal prohormone brain natriuretic peptide (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:
- Age 70 years or greater
- Undergoing intraperitoneal, retroperitoneal, intrathoracic, or major orthopaedic surgery
- History of heart failure
- History of transient ischemic attack
- History of diabetes requiring insulin or oral hypoglycemic medications
- Hypertension
- Serum creatinine greater than 170 mmol/mL
- History of smoking within 2 years of surgery
- 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
Sites / Locations
- St. Paul's Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Colchicine Group
Placebo 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.
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.