Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery (NCT06279000) | Clinical Trial Compass
RecruitingPhase 3
Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery
Switzerland880 participantsStarted 2025-04-20
Plain-language 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.
Who can participate
Age range
45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 w…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.