Using colchicine to reduce heart risks in patients having major non-heart surgery
Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery: Prospective, Randomized, Double-blinded, Placebo-controlled, Multi-centre Study
This study is testing if colchicine can help lower heart risks for patients having major surgeries that aren't related to the heart.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 880 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Cantonal Hospital of St. Gallen Academic / other |
| Locations | 1 site (Sankt Gallen, Canton of St. Gallen) |
| Trial ID | NCT06279000 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing major non-cardiac surgeries who have a defined cardiovascular risk profile.
Not a fit: Patients undergoing low-risk surgeries or those without significant cardiovascular risk factors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of myocardial injury and major cardiovascular events in high-risk surgical patients.
How similar studies have performed: Previous studies have shown promising results with colchicine in reducing cardiovascular events in non-surgical patients, suggesting potential applicability in this surgical context.
Eligibility criteria
Show full inclusion / exclusion 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
* 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 this trial is running
Sankt Gallen, Canton of St. Gallen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.