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

Atrial Fibrillation Clinical Trial

— COP-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03310125
• Other study ID #: 2017-001-COPAF
• Status: Completed
• Phase: Phase 3
• Start date: February 14, 2018
• Est. completion date: July 26, 2023

Study information

• Verified date: August 2023
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 3209
• Est. completion date: July 26, 2023
• Est. primary completion date: July 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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 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 ß-blockers, calcium channels blockers or digoxin;

3. are undergoing minor thoracic interventions/procedures (i.e., minor chest-wall surgeries, chest tube insertions, or needle pleural/lung biopsies);

4. 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);

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 taking effective contraception;

11. 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;

12. are an HIV patient treated with antiretroviral therapy; or

13. are scheduled for thoracoscopic lung wedge resection only.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

Intervention

Drug:
• Colchicine
Over-encapsulated 0.5mg tablet twice daily
• Placebo
Matching placebo capsule twice daily

Locations

Country	Name	City	State
Austria	Vienna General Hospital	Vienna
Belgium	CHU Brugmann UVC	Brussels
Belgium	Hôpital Érasme	Brussels
Belgium	Hôpital Civil Marie Curie	Charleroi
Canada	Foothills Medical Centre	Calgary	Alberta
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	Montreal General Hospital	Montreal	Quebec
Canada	The Ottawa Hospital General Campus	Ottawa	Ontario
Canada	Institut universitaire de cardiologie et de pneumologie de Québec	Québec	Quebec
Canada	CIUSSS de l'Estrie - CHUS	Sherbrooke	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Health Sciences Centre Winnipeg	Winnipeg	Manitoba
Colombia	Fundación Cardioinfantil y LaCardio	Bogotá	Cundinamarca
Hong Kong	Prince of Wales Hospital	Hong Kong
Hong Kong	Tuen Mun Hospital	Hong Kong
Italy	Azienda Ospedaliero Universitaria Careggi	Florence
Italy	IRCCS Ospedale San Raffaele	Milan
Italy	Azienda Ospedaliero-Universitaria Sant'Andrea	Rome
Italy	Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino	Torino
Italy	Ospedale Santa Maria della Misericordia	Udine
Malaysia	Hospital Serdang	Kajang	Selangor
Malaysia	University of Malaya Medical Centre	Kuala Lumpur	Selangor
Pakistan	Shifa International Hospital	Islamabad	Islamabad Capital Territory
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitari Sagrat Cor	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Gregorio Maranon	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Switzerland	Luzerner Kantonsspital	Luzern
Switzerland	Universitätsspital Zürich	Zürich
United States	Fairview Hospital	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Stony Brook University Hospital	Stony Brook	New York
United States	Cleveland Clinic Florida	Weston	Florida
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Population Health Research Institute	Hamilton Health Sciences Corporation

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Colombia,  Hong Kong,  Italy,  Malaysia,  Pakistan,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sepsis or infection	Safety outcome	14 days of randomization
Other	Non-infectious diarrhea	Safety outcome	14 days of randomization
Primary	Clinically important perioperative atrial fibrillation/atrial flutter		14 days of randomization
Primary	Myocardial injury after noncardiac surgery		14 days of randomization
Secondary	First occurrence of the composite of all-cause mortality, nonfatal myocardial injury after noncardiac surgery, or nonfatal stroke		14 days of randomization
Secondary	First occurrence of the composite of all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke		14 days of randomization
Secondary	First occurrence of myocardial injury after noncardiac surgery not fulfilling the 4th universal definition of myocardial infarction		14 days of randomization
Secondary	First occurrence of myocardial infarction		14 days of randomization
Secondary	Time to chest tube removal		14 days of randomization
Secondary	Duration of stay in ICU, step-down, and in-hospital		14 days of randomization