Actively Recruiting
Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery: Prospective, Randomized, Double-blinded, Placebo-controlled, Multi-centre Study
Led by Cantonal Hospital of St. Gallen · Updated on 2025-04-24
880
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of perioperative colchicine administration in patients at increased cardiovascular risk undergoing major non-cardiac surgery. This phase 3 trial aims to reduce the incidence of myocardial injury and major adverse cardiovascular events (MACE) in this population, as current preventive and therapeutic options for these complications are limited. Previous studies in patients with coronary artery disease have shown promising results for colchicine, prompting this evaluation in the surgical setting. Participants will be randomly assigned to receive either colchicine or a placebo in a double-blind manner. The study drug or placebo is first given the evening before surgery, followed by a 1-0-1 dosing schedule (0.5 mg per dose) until the evening of the third postoperative day, totaling nine doses. Both groups receive the same standard perioperative care, with the only difference being the active drug or placebo administration. During the study, patients will undergo preoperative assessments including medical history, medication review, and baseline laboratory tests. Daily high-sensitivity cardiac troponin T measurements are taken until the fourth postoperative day to monitor myocardial injury. Follow-up visits assess primary, secondary, and safety endpoints, with cardiovascular events tracked up to 30 days and one year after surgery. Safety monitoring includes gastrointestinal and other adverse events potentially related to colchicine. The total participation duration includes hospitalization and extended follow-up for long-term outcomes.
CONDITIONS
Brief Title
Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 45 years or older
- Undergoing major non-cardiac surgery under general anesthesia, including vascular (except arteriovenous shunt, vein stripping, carotid endarterectomies), intraperitoneal, intrathoracic, or major orthopedic surgery (spinal or joint replacement)
- At cardiovascular risk defined by at least one of: NT-proBNP ≥ 200 ng/l, history of coronary artery disease, peripheral vascular disease, stroke, or undergoing major vascular surgery (exceptions apply)
- Or fulfilling any 3 of the following: major surgery type as above, history of congestive heart failure or pulmonary edema, transient ischemic attack, diabetes on treatment, age over 70 years, hypertension history, impaired kidney function (creatinine >175 mumol/l or clearance <60 ml/min), smoking within 2 years, surgical time ≥ 90 minutes, planned hospital stay at least one night
- Able to provide written informed consent
You will not qualify if you...
- No written consent provided
- Participation in another clinical trial impacting perioperative medication
- Known intolerance or allergy to colchicine or study drug components
- Pregnancy, planned pregnancy, or breastfeeding
- Significant drug or alcohol abuse within the past year
- Very severe frailty (clinical frailty scale ≥ 8)
- Inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
- Current use of colchicine for other conditions
- Severe kidney impairment (eGFR < 30 ml/min/1.73 m2) or dialysis
- History of solid organ or bone marrow transplant
- Systemic immune suppression (e.g., high-dose steroids or certain diseases)
- Severe liver impairment or active hepatitis with high liver enzymes
- Planned use of certain interacting medications (CYP3A4 substrates like cyclosporine, ketoconazole, clarithromycin, verapamil, quinidine, diltiazem, ritonavir)
- Any other condition deemed risky by the investigator for study participation
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during preoperative consultation
Duration - From the evening before surgery until postoperative day 3
Participants receive either colchicine or placebo starting the evening before surgery and continuing until the third postoperative day.
Daily visits for up to 4 days including surgery day and postoperative days
Duration - Up to 1 year after surgery
Participants are monitored for cardiovascular events until postoperative day 30 and for long-term outcomes up to one year after surgery.
Visits or contacts at postoperative day 30 and periodically up to one year
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
M
Miodrag Filipovic, Prof. MD.
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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