Actively Recruiting
Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery
Led by Cantonal Hospital of St. Gallen · Updated on 2025-04-24
880
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing major non-cardiac surgery under general anesthesia, including vascular surgery (excluding arteriovenous shunt, vein stripping, carotid endarterectomy), intraperitoneal surgery, intrathoracic surgery, or major orthopedic surgery (spinal or joint replacement)
- At cardiovascular risk with at least one of the following: NT-proBNP ≥ 200 ng/l, history of coronary artery disease, peripheral vascular disease, stroke, or undergoing major vascular surgery (excluding certain procedures)
- Alternatively, at least three of the following: major surgery type (intrathoracic, intraperitoneal, supra-inguinal vascular), history of congestive heart failure or pulmonary edema, transient ischemic attack (TIA), diabetes treated with medication, age over 70 years, history of hypertension, impaired kidney function (creatinine >175 mumol/l or clearance <60 ml/min/1.73m2), smoking within 2 years, planned surgery time ≥ 90 minutes, planned hospital stay ≥ 1 night
- Provide written informed consent prior to participation
You will not qualify if you...
- Lack of written consent
- Participation in another clinical trial affecting perioperative medication
- Known allergy or intolerance to colchicine or its components
- Pregnancy, planned pregnancy, or breastfeeding
- Significant drug or alcohol abuse within the last year
- Severe frailty (clinical frailty scale ≥ 8)
- Inflammatory bowel disease such as Crohn's disease or ulcerative colitis
- Current colchicine treatment for other conditions
- Severe renal impairment (eGFR < 30 ml/min/1.73 m2) or need for hemodialysis
- History of solid organ or bone marrow transplantation
- Systemic immunosuppression or related diseases
- Severe liver impairment or active chronic hepatitis
- Planned postoperative use of certain medications metabolized by CYP3A4 (e.g., cyclosporine, ketoconazole, clarithromycin, verapamil)
- Any other condition considered a risk by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cantonal Hospital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
Actively Recruiting
Research Team
T
Timur Yurttas, MD
CONTACT
M
Miodrag Filipovic, Prof. MD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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