Colchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery (COP-AF) (COP-AF)
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|ClinicalTrials.gov Identifier: NCT03310125|
Recruitment Status : Completed
First Posted : October 16, 2017
Last Update Posted : August 7, 2023
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Atrial Flutter Myocardial Injury After Non-Cardiac Surgery||Drug: Colchicine Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3209 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Colchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery (COP-AF)|
|Actual Study Start Date :||February 14, 2018|
|Actual Primary Completion Date :||July 26, 2023|
|Actual Study Completion Date :||July 26, 2023|
Participants received over-encapsulated colchicine 0.5 mg tablet orally twice daily for 10 days.
Over-encapsulated 0.5mg tablet twice daily
Placebo Comparator: Placebo
Participants received matching placebo capsules orally twice daily for 10 days.
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 [ Time Frame: 14 days of randomization ]Safety outcome
- Non-infectious diarrhea [ Time Frame: 14 days of randomization ]Safety outcome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310125
|Principal Investigator:||David Conen, MD, MPH||Population Health Research Institute|
|Study Chair:||PJ Devereaux, MD, PhD||Population Health Research Institute|