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

NCT06279000 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 880

Last updated 2025-04-24

No results posted yet for this study

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.

Conditions

  • Cardiovascular Diseases
  • Cardiovascular Complication
  • Perioperative Complication
  • Myocardial Injury
  • Myocardial Injury After Noncardiac Surgery (MINS)

Interventions

DRUG

Colchicine

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Cantonal Hospital of St. Gallen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-20
Primary Completion
2028-03-30
Completion
2029-03-30

Countries

  • Switzerland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06279000 on ClinicalTrials.gov