Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery: Prospective, Randomized, Double-blinded, Placebo-controlled, Multi-centre Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
Switzerland
Cantonal Hospital St. Gallen
RECRUITING
Sankt Gallen
Contact Information
Primary
Timur Yurttas, MD
timur.yurttas@kssg.ch
0041 714949158
Backup
Miodrag Filipovic, Prof. MD.
miodrag.filipovic@kssg.ch
0041714941111
Time Frame
Start Date: 2025-04-20
Estimated Completion Date: 2029-03-30
Participants
Target number of participants: 880
Treatments
Experimental: Colchicine
The first dose of the IMP is administered in the evening prior to the surgical procedure. Administrations of the study drug follow a 1-0-1 schedule (colchicine 0.5 mg per intake). The last study drug is administered in the evening of the third postoperative day.
Placebo_comparator: Control (Placebo)
Patients in the control group will receive the same perioperative anaesthetic, surgical and medical treatment as patients in the experimental group, the sole difference being that patients will be given a placebo instead of the IMP colchicine.~The first dose of the placebo is administered in the evening prior to the surgical procedure. Administrations of the placebo follow a 1-0-1 schedule. The last placebo is administered in the evening of the third postoperative day.
Related Therapeutic Areas
Sponsors
Leads: Cantonal Hospital of St. Gallen

This content was sourced from clinicaltrials.gov