Perioperative myocardial injury and major adverse cardiovascular events (MACE) are common causes of morbidity and mortality in patients at increased cardiovascular risk undergoing non-cardiac surgery.
However, research in recent years has yielded limited preventive and therapeutic measures for myocardial injury/MACE. Recent studies in patients with chronic and acute coronary artery disease have shown that colchicine administration can reduce the risk of cardiovascular events.
These encouraging results in non-surgical patients ask for a similar investigation in patients undergoing major non-cardiac surgery. The aim of the proposed study is to investigate the effects of perioperative colchicine administration on the incidence of myocardial injury/MACE.
vascular surgery (with the exception of arteriovenous shunt, vein stripping procedures and carotid endarterectomies)
intraperitoneal surgery
intrathoracic surgery
major orthopaedic surgery (spinal surgery or joint replacement surgery)
no written consent
inclusion in other clinical trial with direct impact on perioperative medication
previously reported side effects or reported intolerance from colchicine (e.g., allergic reaction or significant sensitivity to colchicine or an auxiliary substance of the IMP)
pregnancy or planned pregnancy and/or breast feeding
Parallel
Colchicine
DrugColchicine Group: IMP = Colchicine (0.5 mg, enteral) first application in the evening before day of surgery, following a 1-0-1 regimen until the third postoperative day, ending with the application of the ninth dose. Colchicine tablets are provided as 1 mg tablets with a score, which must be divided before ingestion.
Placebo
DrugPlacebo Group: Placebo (identical to IMP in appearance and application) first application in the evening before day of surgery, following a 1-0-1 regimen until the third postoperative day, ending with the application of the ninth dose. Placebo tablets are provided as tablets with a score, which must be divided before ingestion.
Major Adverse Cardiovascular Events
Proportion of patients developing MACE in the peri- postoperative course. MACE is defined as a composite of any of the following within 30 days following surgery: * Acute coronary syndrome * New/worsening congestive heart failure * Coronary revascularization * Stroke * All-cause mortality * Cardiovascular death
Myocardial Injury
Proportion of patients developing myocardial injury in the peri- postoperative course. The primary outcome is a composite of myocardial injury and 30-day MACE. Myocardial injury is defined as an absolute perioperative rise in hs-cTnT of ≥ 14 ng/l above preoperative values (or between two postoperative measurements, if preoperative hs-cTnT is missing).
New onset Atrial fibrillation
Proportion of patients developing new-onset atrial fibrillation in the peri- postoperative course. The time frame includes the time from beginning of surgery (ECG monitoring in the peri- and early postoperative course on postoperative care unit/intensive care unit) until the date of first documented occurrence of atrial fibrillation (perioperative monitoring by daily nurse-controlled pulse examination, verified by an ECG in case of suspected arrhythmia/atrial fibrillation). These monitoring procedures take place until the discharge from the hospital.
postoperative high sensitive cardiac Troponin T concentrations
Comparison of postoperative hs-cTnT concentrations (maximal increase from individual baseline \& the area under the curve) until postoperative day 4 between the study groups
long term cardiovascular outcome
Proportion of patients developing MACE in regard of long term cardiovascular outcome after surgery.1-year composite endpoint of MACE (composite of acute coronary syndrome, new or worsening congestive heart failure, coronary revascularization, stroke, all-cause mortality and cardiovascular mortality) as a marker of long-term postoperative outcome.
Gastrointestinal adverse events
Proportion of patients developing gastrointestinal side effects as: diarrhoea, abdominal cramping, abdominal pain, vomiting, nausea after the intervention
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