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

Completed · Phase 3 · Has a placebo group

Conditions studied: Atrial Fibrillation, Atrial Flutter, Myocardial Injury After Non-Cardiac Surgery

In brief

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.

Key facts

Study ID

NCT03310125

Run by

Population Health Research Institute

People needed

3209

Starts

2018-02-14

Expected to finish

2023-07-26

Last updated by the study team

2023-08-07

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cleveland Clinic Florida — Weston, Florida, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Stony Brook University Hospital — Stony Brook, New York, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• Fairview Hospital — Cleveland, Ohio, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Vienna General Hospital — Vienna, Austria
• CHU Brugmann UVC — Brussels, Belgium
• Hôpital Érasme — Brussels, Belgium
• Hôpital Civil Marie Curie — Charleroi, Belgium
• Foothills Medical Centre — Calgary, Alberta, Canada
• Vancouver General Hospital — Vancouver, British Columbia, Canada
• Health Sciences Centre Winnipeg — Winnipeg, Manitoba, Canada
• Victoria General Hospital — Halifax, Nova Scotia, Canada
• St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada
• Kingston General Hospital — Kingston, Ontario, Canada
• Victoria Hospital — London, Ontario, Canada
• The Ottawa Hospital General Campus — Ottawa, Ontario, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• Montreal General Hospital — Montreal, Quebec, Canada
• Institut universitaire de cardiologie et de pneumologie de Québec — Québec, Quebec, Canada
• CIUSSS de l'Estrie - CHUS — Sherbrooke, Quebec, Canada
• Fundación Cardioinfantil y LaCardio — Bogotá, Cundinamarca, Colombia

Full record on ClinicalTrials.gov

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