Colchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery (COP-AF)
- Conditions
- Myocardial Injury After Non-Cardiac SurgeryAtrial FibrillationAtrial Flutter
- Interventions
- Drug: Placebo
- Registration Number
- NCT03310125
- Lead Sponsor
- Population Health Research Institute
- 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 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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3209
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Colchicine Colchicine Participants received over-encapsulated colchicine 0.5 mg tablet orally twice daily for 10 days. Placebo Placebo Participants received matching placebo capsules orally twice daily for 10 days.
- Primary Outcome Measures
Name Time Method Clinically important perioperative atrial fibrillation/atrial flutter 14 days of randomization Myocardial injury after noncardiac surgery 14 days of randomization
- Secondary Outcome Measures
Name Time Method First occurrence of myocardial infarction 14 days of randomization First occurrence of the composite of all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke 14 days of randomization Time to chest tube removal 14 days of randomization Duration of stay in ICU, step-down, and in-hospital 14 days of randomization First occurrence of the composite of all-cause mortality, nonfatal myocardial injury after noncardiac surgery, or nonfatal stroke 14 days of randomization First occurrence of myocardial injury after noncardiac surgery not fulfilling the 4th universal definition of myocardial infarction 14 days of randomization
Trial Locations
- Locations (44)
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Fairview Hospital
🇺🇸Cleveland, Ohio, United States
Vienna General Hospital
🇦🇹Vienna, Austria
Victoria General Hospital
🇨🇦Halifax, Nova Scotia, Canada
Hôpital Érasme
🇧🇪Brussels, Belgium
Hôpital Civil Marie Curie
🇧🇪Charleroi, Belgium
Health Sciences Centre Winnipeg
🇨🇦Winnipeg, Manitoba, Canada
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Montreal General Hospital
🇨🇦Montreal, Quebec, Canada
Azienda Ospedaliero-Universitaria Sant'Andrea
🇮🇹Rome, Italy
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
🇮🇹Torino, Italy
Shifa International Hospital
🇵🇰Islamabad, Islamabad Capital Territory, Pakistan
Ospedale Santa Maria della Misericordia
🇮🇹Udine, Italy
Hospital Serdang
🇲🇾Kajang, Selangor, Malaysia
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitari Sagrat Cor
🇪🇸Barcelona, Spain
Victoria Hospital
🇨🇦London, Ontario, Canada
The Ottawa Hospital General Campus
🇨🇦Ottawa, Ontario, Canada
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Institut universitaire de cardiologie et de pneumologie de Québec
🇨🇦Québec, Quebec, Canada
Fundación Cardioinfantil y LaCardio
🇨🇴Bogotá, Cundinamarca, Colombia
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
IRCCS Ospedale San Raffaele
🇮🇹Milan, Italy
Azienda Ospedaliero Universitaria Careggi
🇮🇹Florence, Italy
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Luzerner Kantonsspital
🇨🇭Luzern, Switzerland
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Universitätsspital Zürich
🇨🇭Zürich, Switzerland
CHU Brugmann UVC
🇧🇪Brussels, Belgium
Prince of Wales Hospital
🇭🇰Hong Kong, Hong Kong
University of Malaya Medical Centre
🇲🇾Kuala Lumpur, Selangor, Malaysia
CIUSSS de l'Estrie - CHUS
🇨🇦Sherbrooke, Quebec, Canada
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada
Tuen Mun Hospital
🇭🇰Hong Kong, Hong Kong