Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery
Status: Not yet recruiting

Perioperative myocardial injury/infarction (PMI) 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 PMI/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 PMI/MACE.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  undergoing major non-cardiac surgery in general anaesthesia will be included. Major non-cardiac surgery is defined as:  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)  at cardiovascular risk, defined as meeting at least 1 of the following 6 criteria:  preoperative n-terminal pro brain natriuretic peptide (NT-proBNP) ≥ 200 ng/l history of coronary artery disease history of peripheral vascular disease history of stroke undergoing major vascular surgery, with the exception of arteriovenous shunt, vein stripping procedures and carotid endarterectomies  fulfilment of any 3 of the 8 following criteria:  undergoing major surgery (intrathoracic, intraperitoneal or supra-inguinal vascular surgery) any history of congestive heart failure or history of pulmonary oedema anamnestic transient ischemic attack (TIA) diabetes under treatment with either oral antidiabetic agent or insulin age > 70 years history of hypertension serum creatinine > 175 mumol/l or calculated creatinine clearance < 60 ml/min/1.73m2 (cockcroft gault) history of smoking within 2 years of surgery planned surgical time ≥ 90 minutes planned postoperative hospital stay at least 1 night  Exclusion Criteria:  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 clinically significant history of drug or alcohol abuse within the last year very severe frailty (≥ 8 clinical frailty scale) patient with inflammatory bowel disease (e.g., Morbus Crohn or Colitis ulcerosa) patient taking colchicine for other indications (e.g., familial Mediterranean fever, gout) severe renal impairment (eGFR < 30 ml min -1 1.73 m2 -1) or end-stage renal disease with indication for haemodialysis history of solid organ or bone marrow transplantation systemic immune-suppression (medication (steroids >30mg cortisol-equivalent per day, tacrolimus etc...) or disease (e.g., myelodysplastic syndrome) severe hepatic impairment with history of cirrhosis chronic active hepatitis or functional disorders defined as alanine aminotransferase greater than three times the upper limit of normal anticipated post-operative administration of CYP3A4 metabolized substances like cyclosporine, ketoconazole, clarithromycin, verapamil, quinidine, diltiazem or ritonavir Any other condition that the investigator would consider a risk to the patient if the latter were to participate in the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 45 Years - StdAgeList: Adult, Older Adult