A Phase 3 interventional study of Colchicine and Placebo in Atrial Fibrillation, Atrial Flutter and Myocardial Injury After Non-Cardiac Surgery, sponsored by Population Health Research Institute. Completed at 44 sites in 11 countries. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2023-08-07.
Sponsored by Population Health Research Institute · Phase 3, Interventional, and Prevention
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.
Perioperative atrial fibrillation (AF) and myocardial injury after noncardiac surgery (MINS) are among the most common serious complications occurring after thoracic surgery. AF is the most common perioperative cardiac arrhythmia. The incidence of perioperative AF in patients undergoing major thoracic surgery ranges from 10% in low-risk patients to as high as 20% in high-risk patients. The course of patients with perioperative AF is frequently complicated by hemodynamic instability, problems with managing anticoagulation in the early postoperative period, prolonged intensive care unit and hospital stays, and increased costs. Patients who develop perioperative AF (POAF) or MINS also have a significantly increased risk of death and stroke.
Colchicine is an inexpensive drug and a highly effective anti-inflammatory agent that holds great potential for preventing POAF and MINS in patients undergoing thoracic surgery. Data from cardiac surgery patients suggest that prevention of POAF using colchicine is feasible, but whether this concept is also applicable to patients undergoing thoracic surgery, where the risk of POAF is lower and underlying mechanisms may be different, is currently unclear. The 'Colchicine for the prevention of perioperative AF' (COP-AF) trial has been designed as a large randomized, double blind, placebo controlled trial to determine whether colchicine, a potent, safe and inexpensive anti-inflammatory drug, lowers the risk of perioperative AF, MINS, and other inflammatory complications in patients undergoing thoracic surgery. The primary objective of this trial is to determine whether a 10-day course of colchicine 0.5mg twice daily reduces the incidence of perioperative AF and MINS within 14 days after thoracic surgery.
Patients are eligible if they:
Exclusion Criteria:
Patients will be excluded if they:
Participants received over-encapsulated colchicine 0.5 mg tablet orally twice daily for 10 days.
Drug: Colchicine
Participants received matching placebo capsules orally twice daily for 10 days.
Drug: Placebo
Over-encapsulated 0.5mg tablet twice daily
Matching placebo capsule twice daily
Clinically important perioperative atrial fibrillation/atrial flutter
Time frame: 14 days of randomization
Myocardial injury after noncardiac surgery
Time frame: 14 days of randomization
First occurrence of the composite of all-cause mortality, nonfatal myocardial injury after noncardiac surgery, or nonfatal stroke
Time frame: 14 days of randomization
First occurrence of the composite of all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke
Time frame: 14 days of randomization
First occurrence of myocardial injury after noncardiac surgery not fulfilling the 4th universal definition of myocardial infarction
Time frame: 14 days of randomization
First occurrence of myocardial infarction
Time frame: 14 days of randomization
Time to chest tube removal
Time frame: 14 days of randomization
Duration of stay in ICU, step-down, and in-hospital
Time frame: 14 days of randomization
Sepsis or infection
Safety outcome
Time frame: 14 days of randomization
Non-infectious diarrhea
Safety outcome
Time frame: 14 days of randomization
Plan to share: Undecided
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Population Health Research Institute