Status:
COMPLETED
Colchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery (COP-AF)
Lead Sponsor:
Population Health Research Institute
Collaborating Sponsors:
Hamilton Health Sciences Corporation
Conditions:
Atrial Fibrillation
Atrial Flutter
Eligibility:
All Genders
55+ years
Phase:
PHASE3
Brief 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...
Detailed Description
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 per...
Eligibility Criteria
Inclusion
- Patients are eligible if they:
- are undergoing thoracic surgery with general anesthesia;
- are greater than or equal to 55 years of age at the time of randomization;
- are expected to require at least an overnight hospital admission after surgery; and
- provide written informed consent to participate.
Exclusion
- Patients will be excluded if they:
- have a prior history of documented atrial fibrillation;
- are currently taking anti-arrhythmic medication other than β-blockers, calcium channels blockers or digoxin;
- are undergoing minor thoracic interventions/procedures (i.e., minor chest-wall surgeries, chest tube insertions, or needle pleural/lung biopsies);
- have a contraindication to colchicine (i.e., allergy to colchicine, myelodysplastic disorders, or an estimated glomerular filtration rate less than 30 mL/min/1.73m);
- are not expected to take oral medications for greater than 24 hours after surgery (e.g., esophagectomy);
- are scheduled for lung transplantation;
- are currently taking non-study colchicine before surgery;
- have severe hepatic dysfunction;
- have aplastic anemia;
- are a woman of childbearing potential who is pregnant, breastfeeding, or not taking effective contraception;
- took within the last 14 days or are scheduled to take during the first 10 days after surgery clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole, or itraconazole;
- are an HIV patient treated with antiretroviral therapy; or
- are scheduled for thoracoscopic lung wedge resection only.
Key Trial Info
Start Date :
February 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2023
Estimated Enrollment :
3209 Patients enrolled
Trial Details
Trial ID
NCT03310125
Start Date
February 14 2018
End Date
July 26 2023
Last Update
August 7 2023
Active Locations (44)
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1
Cleveland Clinic Florida
Weston, Florida, United States, 33331
2
Henry Ford Hospital
Detroit, Michigan, United States, 48202
3
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
4
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157