RecruitingPhase 3NCT06279000

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

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


Sponsor

Cantonal Hospital of St. Gallen

Enrollment

880 participants

Start Date

Apr 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Colchicine and a drug called Placebo for people with cardiovascular complication, cardiovascular diseases, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGColchicine

Colchicine Group: IMP = Colchicine (0.5 mg, enteral) first application in the evening before day of surgery, following a 1-0-1 regimen until the third postoperative day, ending with the application of the ninth dose. Colchicine tablets are provided as 1 mg tablets with a score, which must be divided before ingestion.

DRUGPlacebo

Placebo Group: Placebo (identical to IMP in appearance and application) first application in the evening before day of surgery, following a 1-0-1 regimen until the third postoperative day, ending with the application of the ninth dose. Placebo tablets are provided as tablets with a score, which must be divided before ingestion.


Locations(1)

Cantonal Hospital St. Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

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NCT06279000


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