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

Last updated: August 3, 2023
Sponsor: Population Health Research Institute
Overall Status: Completed

Phase

3

Condition

Chest Pain

Atrial Flutter

Dysrhythmia

Treatment

Colchicine

Placebo

Clinical Study ID

NCT03310125
2017-001-COPAF
  • Ages > 55
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Patients are eligible if they:

  1. are undergoing thoracic surgery with general anesthesia;
  2. are greater than or equal to 55 years of age at the time of randomization;
  3. are expected to require at least an overnight hospital admission after surgery; and
  4. provide written informed consent to participate.

Exclusion

Exclusion Criteria: Patients will be excluded if they:

  1. have a prior history of documented atrial fibrillation;
  2. are currently taking anti-arrhythmic medication other than β-blockers, calciumchannels blockers or digoxin;
  3. are undergoing minor thoracic interventions/procedures (i.e., minor chest-wallsurgeries, chest tube insertions, or needle pleural/lung biopsies);
  4. have a contraindication to colchicine (i.e., allergy to colchicine, myelodysplasticdisorders, or an estimated glomerular filtration rate less than 30 mL/min/1.73m);
  5. are not expected to take oral medications for greater than 24 hours after surgery (e.g., esophagectomy);
  6. are scheduled for lung transplantation;
  7. are currently taking non-study colchicine before surgery;
  8. have severe hepatic dysfunction;
  9. have aplastic anemia;
  10. are a woman of childbearing potential who is pregnant, breastfeeding, or not takingeffective contraception;
  11. took within the last 14 days or are scheduled to take during the first 10 days aftersurgery clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole, oritraconazole;
  12. are an HIV patient treated with antiretroviral therapy; or
  13. are scheduled for thoracoscopic lung wedge resection only.

Study Design

Total Participants: 3209
Treatment Group(s): 2
Primary Treatment: Colchicine
Phase: 3
Study Start date:
February 14, 2018
Estimated Completion Date:
July 26, 2023

Study 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.

Connect with a study center

  • Vienna General Hospital

    Vienna, 1090
    Austria

    Site Not Available

  • CHU Brugmann UVC

    Brussels, 1020
    Belgium

    Site Not Available

  • Hôpital Érasme

    Brussels, 1070
    Belgium

    Site Not Available

  • Hôpital Civil Marie Curie

    Charleroi, 6042
    Belgium

    Site Not Available

  • Foothills Medical Centre

    Calgary, Alberta T2N 2T9
    Canada

    Site Not Available

  • Royal Alexandra Hospital

    Edmonton, Alberta T5H 3V9
    Canada

    Site Not Available

  • Vancouver General Hospital

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • Health Sciences Centre Winnipeg

    Winnipeg, Manitoba R3A 1R9
    Canada

    Site Not Available

  • Victoria General Hospital

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Site Not Available

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario L8N 4A6
    Canada

    Site Not Available

  • Kingston General Hospital

    Kingston, Ontario K7L 2V7
    Canada

    Site Not Available

  • Victoria Hospital

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • The Ottawa Hospital General Campus

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Toronto General Hospital

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • Montreal General Hospital

    Montreal, Quebec H3G 1A4
    Canada

    Site Not Available

  • Institut universitaire de cardiologie et de pneumologie de Québec

    Québec, Quebec G1V 4G5
    Canada

    Site Not Available

  • CIUSSS de l'Estrie - CHUS

    Sherbrooke, Quebec J1H 5H3
    Canada

    Site Not Available

  • Prince of Wales Hospital

    Hong-Kong,
    China

    Site Not Available

  • Fundación Cardioinfantil y LaCardio

    Bogotá, Cundinamarca
    Colombia

    Site Not Available

  • Prince of Wales Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • Tuen Mun Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134
    Italy

    Site Not Available

  • IRCCS Ospedale San Raffaele

    Milan, 20132
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Sant'Andrea

    Rome, 00189
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino

    Torino, 10126
    Italy

    Site Not Available

  • Ospedale Santa Maria della Misericordia

    Udine, 33100
    Italy

    Site Not Available

  • Hospital Serdang

    Kajang, Selangor 43000
    Malaysia

    Site Not Available

  • University of Malaya Medical Centre

    Kuala Lumpur, Selangor 59100
    Malaysia

    Site Not Available

  • Shifa International Hospital

    Islamabad, Islamabad Capital Territory 44000
    Pakistan

    Site Not Available

  • Rehman Medical Institute

    Peshawar, Khyber Pakhtunkhwa 25000
    Pakistan

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitari Sagrat Cor

    Barcelona, 08029
    Spain

    Site Not Available

  • Hospital Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025
    Spain

    Site Not Available

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Site Not Available

  • Hospital Gregorio Maranon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Luzerner Kantonsspital

    Luzern,
    Switzerland

    Site Not Available

  • Universitätsspital Zürich

    Zürich, 8091
    Switzerland

    Site Not Available

  • Cleveland Clinic Florida

    Weston, Florida 33331
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Stony Brook University Hospital

    Stony Brook, New York 11794
    United States

    Site Not Available

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Fairview Hospital

    Cleveland, Ohio 44111
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • OHSU Hospital

    Portland, Oregon 97239
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

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