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Colchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery (COP-AF)

NCT03310125 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3209

Last updated 2023-08-07

No results posted yet for this study

Summary

The prevention of perioperative atrial fibrillation (AF) and myocardial injury after non-cardiac surgery (MINS) has the potential to reduce mortality, stroke, and hospital stays in patients undergoing major thoracic surgery. Data from cardiac surgery patients suggest that prevention of perioperative atrial fibrillation using an anti-inflammatory agent, such as colchicine, is feasible. The COP-AF trial will assess whether the administration of oral colchicine will reduce the incidence of perioperative atrial fibrillation and myocardial injury after non-cardiac surgery in patients undergoing major thoracic surgery.

Conditions

Interventions

DRUG

Colchicine

Over-encapsulated 0.5mg tablet twice daily

DRUG

Placebo

Matching placebo capsule twice daily

Sponsors & Collaborators

  • Hamilton Health Sciences Corporation

    collaborator OTHER

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • David Conen, MD, MPH · Population Health Research Institute

  • PJ Devereaux, MD, PhD · Population Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-14
Primary Completion
2023-07-26
Completion
2023-07-26
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Colombia
  • Hong Kong
  • Italy
  • Malaysia
  • Pakistan
  • Spain
  • Switzerland

Study Locations

More Related Trials

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 NCT03310125 on ClinicalTrials.gov