Using colchicine to reduce heart risks in patients having major non-heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 interventional study investigates the effects of colchicine on patients at increased cardiovascular risk undergoing major non-cardiac surgeries. It is a double-blind, placebo-controlled trial conducted at the Cantonal Hospital St. Gallen and the University Hospital Basel in Switzerland, with plans to expand to additional centers. Participants will receive either colchicine or a placebo starting the evening before surgery and continuing until three days post-surgery, with daily monitoring of cardiac biomarkers to assess the incidence of myocardial injury and major adverse cardiovascular events (MACE). The study aims to provide insights into the efficacy of colchicine in reducing these risks during the perioperative period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cantonal Hospital St. Gallen
  Sankt Gallen, Canton of St. Gallen, Switzerland Recruiting

Study contacts

• Study coordinator: Timur Yurttas, MD
• Email: timur.yurttas@kssg.ch
• Phone: 0041 714949158

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.