Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age45+
SponsorCantonal Hospital of St. Gallen

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Colchicine
  • Placebo

Treatment groups

880 Participants
are divided into 2 treatment groups