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Colchicine Prevents Myocardial Injury After Non-Cardiac Surgery Pilot Study

NCT04139655 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-11-19

No results posted yet for this study

Summary

Perioperative Myocardial Infarction (PMI) is a major contributor to perioperative mortality and morbidity with overall incidence of 5-16%. It is associated with increased 30-day mortality of 11.6% vs 2.2% of patients without PMI in non-cardiac surgical patients. However, its recognition and diagnosis remains challenging as the typical symptoms and findings of ischemic MI may be masked by post-operative changes and pain management.

In this study, the investigators hope to determine if colchicine decreases the incidence of MINS in high risk surgical patients undergoing non-cardiac surgery and optimally establish colchicine as a viable therapy to improve perioperative cardiovascular outcome in those patients.

Conditions

Interventions

DRUG

Colchicine 0.6 mg

Oral colchicine given at 0.6 mg 1 hour prior to surgery, then 0.6 mg twice daily starting on the night after surgery for 7 days or until discharge from hospital, whichever occurs earlier. For patient under 60kg in body weight, daily dose will be 0.6 mg once daily. Medical and surgical management of the participant will be carried out under each institute's standard clinical practice.

DRUG

Placebo oral tablet

Placebo oral tablet given at 0.6 mg 1 hour prior to surgery, then 0.6 mg twice daily starting on the night after surgery for 7 days or until discharge from hospital, whichever occurs earlier. For patient under 60kg in body weight, daily dose will be 0.6 mg once daily. Medical and surgical management of the participant will be carried out under each institute's standard clinical practice.

Sponsors & Collaborators

  • Providence Health & Services

    collaborator OTHER

  • Vancouver Coastal Health

    collaborator OTHER_GOV

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Ron Ree, MD · Providence Health Care and UBC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-09-01
Completion
2021-10-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

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 NCT04139655 on ClinicalTrials.gov