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Recruiting Phase 3 NCT06279000

Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery

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Trial Parameters

Condition Cardiovascular Diseases
Sponsor Cantonal Hospital of St. Gallen
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 880
Sex ALL
Min Age 45 Years
Max Age N/A
Start Date 2025-04-20
Completion 2028-03-30
Interventions
ColchicinePlacebo

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Brief Summary

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.

Eligibility Criteria

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 *

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