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CompletedNCT03310125COP-AFUpdated Oct 16, 2026Results posted

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

A Phase 3 interventional study of Active Colchicine and Active Placebo in Atrial Fibrillation, Atrial Flutter and Myocardial Injury After Non-Cardiac Surgery, sponsored by Population Health Research Institute. Completed at 46 sites in 11 countries. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Population Health Research Institute · Phase 3, Interventional, and Prevention

Updated Oct 16, 2026Results postedStudy documents posted+8 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
3,209
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Atrial Fibrillation
  • Atrial Flutter
  • Myocardial Injury After Non-Cardiac Surgery

Keywords

  • Atrial Fibrillation
  • Inflammation
  • Thoracic Surgery
  • Randomized
  • Colchicine
  • Myocardial Injury
03

In context

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

This study's enrollment of 3,209 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Population Health Research Institute is the lead sponsor of 115 studies on the registry; 26 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Browse Population Health Research Institute studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 16, 2026. See what changed

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to participate.

Exclusion criteria

Exclusion Criteria:

We will exclude patients who meet any of the following criteria:

  1. patients with a prior history of documented AF;
  2. patients currently taking anti-arrhythmic medication other than β-blockers, calcium channels blockers or digoxin;
  3. patients undergoing minor thoracic interventions/procedures (i.e., minor chest-wall surgeries, chest tube insertions, or needle pleural/lung );
  4. patients with to colchicine (i.e., allergy to colchicine, myelodysplastic disorders, or an estimated [eGFR] \<30 mL/min/1.73m);
  5. patients not expected to take oral medications for >24 hours after surgery (e.g., esophagectomy);
  6. patients scheduled for lung transplantation;
  7. patients currently taking non-study colchicine before surgery;
  8. patients with severe hepatic dysfunction;
  9. patients with aplastic anemia;
  10. women of who are not taking effective , pregnant or breast-feeding;
  11. patients who took within the last 14 days or scheduled to take during the first 10 days after surgery clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole, or itraconazole* (While systemic administration of these medications is contraindicated, patients with local administration only (e.g., eye drops, creams) are eligible for the trial);
  12. (HIV) patients treated with antiretroviral therapy; or
  13. patients scheduled for thoracoscopic lung wedge resection only†. (Patients scheduled for multiple thoracoscopic lung wedge resection only are eligible for inclusion).
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
3,209 participants (actual)

Study arms

  • Experimental
    Active Colchicine

    Oral colchicine 0·5 mg twice daily, starting within 4 h before surgery and continuing for 10 days

    Drug: Active Colchicine

  • Placebo comparator
    Active Placebo

    Oral placebo 0·5 mg twice daily, starting within 4 h before surgery and continuing for 10 days.

    Drug: Active Placebo

Interventions

  • DrugActive Colchicine

    Oral colchicine 0·5 mg twice daily, starting within 4 h before surgery and continuing for 10 days.

  • DrugActive Placebo

    Oral placebo 0·5 mg twice daily, starting within 4 h before surgery and continuing for 10 days.

06

What researchers measure

Primary outcomes

  1. Number of Participants With Clinically Important Perioperative Atrial Fibrillation

    Clinically important perioperative atrial fibrillation was defined as atrial fibrillation or atrial flutter that results in angina, heart failure, or symptomatic hypotension, or that requires treatment with a rate-controlling drug, anti-arrhythmic drug, or electrical cardioversion.

    Time frame: 14 days after randomisation

  2. Number of Participants With Myocardial Injury After Non-cardiac Surgery (MINS)

    Time frame: 14 days after randomisation

Secondary outcomes

  1. Number of Participants With Composite of All-cause Death, Non-fatal MINS, and Non-fatal Stroke

    Time frame: 14 days after randomisation

  2. Number of Participants With Composite of All-cause Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke

    Time frame: 14 days after randomisation

  3. Number of Participants With MINS Not Fulfilling the Fourth Universal Definition of Myocardial Infarction

    Time frame: 14 days after randomisation

  4. Number of Participants With Myocardial Infarction

    Time frame: 14 days after randomisation

  5. Time to Chest Tube Removal, Days

    Time frame: 14 days after randomisation

  6. Days in Hospital

    Time frame: 14 days after randomisation

  7. Nights in Step-down Unit

    Time frame: 14 days after randomisation

  8. Nights in Intensive Care Unit

    Time frame: 14 days after randomisation

Other outcomes

  1. Tertiary Outcome: Number of Participants With All-cause Death

    Time frame: 14 days after randomization

  2. Tertiary Outcome: Number of Participants With Deep Venous Thrombosis or Pulmonary Embolism

    Time frame: 14 days after randomisation

  3. Tertiary Outcome: Number of Participants With Composite of Life-threatening or Major Bleeding

    Time frame: 14 days after randomisation

  4. Tertiary Outcome: Days Alive and at Home

    Time frame: 14 days after randomisation

07

Results

Posted Oct 16, 2026

Participant flow

Participant flow — Overall Study
MilestoneActive ColchicineActive Placebo
Started16081601
Completed16081601
Not completed00

Outcome measures

PrimaryNumber of Participants With Clinically Important Perioperative Atrial Fibrillation

Clinically important perioperative atrial fibrillation was defined as atrial fibrillation or atrial flutter that results in angina, heart failure, or symptomatic hypotension, or that requires treatment with a rate-controlling drug, anti-arrhythmic drug, or electrical cardioversion.

Time frame:
14 days after randomisation
Reported as:
Count of participants · Participants
Number of Participants With Clinically Important Perioperative Atrial Fibrillation
ParticipantsActive ColchicineActive Placebo
Number of Participants With Clinically Important Perioperative Atrial Fibrillation103120
Statistical analysis
  • Active Colchicine vs Active Placebo · Regression, Cox · p = 0.22 · Hazard ratio (hr): 0.85 · 95% CI 0.65 to 1.1
PrimaryNumber of Participants With Myocardial Injury After Non-cardiac Surgery (MINS)
Time frame:
14 days after randomisation
Reported as:
Count of participants · Participants
Number of Participants With Myocardial Injury After Non-cardiac Surgery (MINS)
ParticipantsActive ColchicineActive Placebo
Number of Participants With Myocardial Injury After Non-cardiac Surgery (MINS)295325
Statistical analysis
  • Active Colchicine vs Active Placebo · Regression, Cox · p = 0.16 · Hazard ratio (hr): 0.89 · 95% CI 0.76 to 1.05
SecondaryNumber of Participants With Composite of All-cause Death, Non-fatal MINS, and Non-fatal Stroke
Time frame:
14 days after randomisation
Reported as:
Count of participants · Participants
Number of Participants With Composite of All-cause Death, Non-fatal MINS, and Non-fatal Stroke
ParticipantsActive ColchicineActive Placebo
Number of Participants With Composite of All-cause Death, Non-fatal MINS, and Non-fatal Stroke300335
Statistical analysis
  • Active Colchicine vs Active Placebo · Regression, Cox · p = 0.11 · Hazard ratio (hr): 0.88 · 95% CI 0.75 to 1.03
SecondaryNumber of Participants With Composite of All-cause Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke
Time frame:
14 days after randomisation
Reported as:
Count of participants · Participants
Number of Participants With Composite of All-cause Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke
ParticipantsActive ColchicineActive Placebo
Number of Participants With Composite of All-cause Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke2131
Statistical analysis
  • Active Colchicine vs Active Placebo · Regression, Cox · p = 0.16 · Hazard ratio (hr): 0.67 · 95% CI 0.39 to 1.17
SecondaryNumber of Participants With MINS Not Fulfilling the Fourth Universal Definition of Myocardial Infarction
Time frame:
14 days after randomisation
Reported as:
Count of participants · Participants
Number of Participants With MINS Not Fulfilling the Fourth Universal Definition of Myocardial Infarction
ParticipantsActive ColchicineActive Placebo
Number of Participants With MINS Not Fulfilling the Fourth Universal Definition of Myocardial Infarction285311
Statistical analysis
  • Active Colchicine vs Active Placebo · Regression, Cox · p = 0.22 · Hazard ratio (hr): 0.9 · 95% CI 0.76 to 1.06
SecondaryNumber of Participants With Myocardial Infarction
Time frame:
14 days after randomisation
Reported as:
Count of participants · Participants
Number of Participants With Myocardial Infarction
ParticipantsActive ColchicineActive Placebo
Number of Participants With Myocardial Infarction1315
Statistical analysis
  • Active Colchicine vs Active Placebo · Regression, Cox · p = 0.69 · Hazard ratio (hr): 0.86 · 95% CI 0.41 to 1.81
SecondaryTime to Chest Tube Removal, Days
Time frame:
14 days after randomisation
Reported as:
Median · Days
Time to Chest Tube Removal, Days
DaysActive ColchicineActive Placebo
Time to Chest Tube Removal, Days4.0 (3.0 to 6.0)4.0 (3.0 to 6.0)
Statistical analysis
  • Active Colchicine vs Active Placebo · Wilcoxon (Mann-Whitney) · p = 0.27
SecondaryDays in Hospital
Time frame:
14 days after randomisation
Reported as:
Mean · Days
Days in Hospital
DaysActive ColchicineActive Placebo
Days in Hospital5.0 (3.0 to 7.0)5.0 (3.0 to 7.0)
Statistical analysis
  • Active Colchicine vs Active Placebo · Wilcoxon (Mann-Whitney) · p = 0.48
SecondaryNights in Step-down Unit
Time frame:
14 days after randomisation
Reported as:
Median · Nights
Nights in Step-down Unit
NightsActive ColchicineActive Placebo
Nights in Step-down Unit1.0 (0.0 to 3.0)1.0 (0.0 to 3.0)
Statistical analysis
  • Active Colchicine vs Active Placebo · Wilcoxon (Mann-Whitney) · p = 0.56
SecondaryNights in Intensive Care Unit
Time frame:
14 days after randomisation
Reported as:
Median · Nights
Nights in Intensive Care Unit
NightsActive ColchicineActive Placebo
Nights in Intensive Care Unit0.0 (0.0 to 0.0)0.0 (0.0 to 0.0)
Statistical analysis
  • Active Colchicine vs Active Placebo · Wilcoxon (Mann-Whitney) · p = 0.91
Other pre-specifiedTertiary Outcome: Number of Participants With All-cause Death
Time frame:
14 days after randomization
Reported as:
Count of participants · Participants
Tertiary Outcome: Number of Participants With All-cause Death
ParticipantsActive ColchicineActive Placebo
Tertiary Outcome: Number of Participants With All-cause Death711
Statistical analysis
  • Active Colchicine vs Active Placebo · Regression, Cox · p = 0.35 · Hazard ratio (hr): 0.63 · 95% CI 0.25 to 1.63
Other pre-specifiedTertiary Outcome: Number of Participants With Deep Venous Thrombosis or Pulmonary Embolism
Time frame:
14 days after randomisation
Reported as:
Count of participants · Participants
Tertiary Outcome: Number of Participants With Deep Venous Thrombosis or Pulmonary Embolism
ParticipantsActive ColchicineActive Placebo
Tertiary Outcome: Number of Participants With Deep Venous Thrombosis or Pulmonary Embolism156
Statistical analysis
  • Active Colchicine vs Active Placebo · Regression, Cox · p = 0.058 · Hazard ratio (hr): 2.5 · 95% CI 0.97 to 6.44
Other pre-specifiedTertiary Outcome: Number of Participants With Composite of Life-threatening or Major Bleeding
Time frame:
14 days after randomisation
Reported as:
Count of participants · Participants
Tertiary Outcome: Number of Participants With Composite of Life-threatening or Major Bleeding
ParticipantsActive ColchicineActive Placebo
Tertiary Outcome: Number of Participants With Composite of Life-threatening or Major Bleeding4752
Statistical analysis
  • Active Colchicine vs Active Placebo · Regression, Cox · p = 0.59 · Hazard ratio (hr): 0.9 · 95% CI 0.6 to 1.33
Other pre-specifiedTertiary Outcome: Days Alive and at Home
Time frame:
14 days after randomisation
Reported as:
Median · Days
Tertiary Outcome: Days Alive and at Home
DaysActive ColchicineActive Placebo
Tertiary Outcome: Days Alive and at Home10 (8.0 to 12.0)10 (8.0 to 12.0)
Statistical analysis
  • Active Colchicine vs Active Placebo · Wilcoxon (Mann-Whitney) · p = 0.99

Adverse events

Collected over Study personnel followed up patients daily until discharge. Daily cardiac troponin levels were obtained during the first 3 postoperative days. The final follow-up visit occurred 14 days after randomisation; no ECG was mandated at the final follow-up visit. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Active Colchicine7/1,608 (0.4%)67/1,608 (4.2%)0/1,608 (0%)
Active Placebo11/1,601 (0.7%)66/1,601 (4.1%)0/1,601 (0%)
Most frequent serious events
Showing 10 of 65
Most frequent serious events
EventActive ColchicineActive Placebo
Pulmonary air leakageRespiratory, thoracic and mediastinal disorders9/160812/1601
Subcutaneous emphysemaSkin and subcutaneous tissue disorders7/16086/1601
PneumothoraxRespiratory, thoracic and mediastinal disorders4/16086/1601
Respiratory failureRespiratory, thoracic and mediastinal disorders5/16086/1601
Acute respiratory failureRespiratory, thoracic and mediastinal disorders1/16083/1601
ChylothoraxRespiratory, thoracic and mediastinal disorders2/16083/1601
HypotensionVascular disorders3/16082/1601
EmphysemaRespiratory, thoracic and mediastinal disorders3/16082/1601
Pleural effusionRespiratory, thoracic and mediastinal disorders3/16081/1601
HypoxiaRespiratory, thoracic and mediastinal disorders2/16082/1601

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Active ColchicineActive PlaceboTotal
<=18 years000
Between 18 and 65 years5365241060
>=65 years107210772149
Sex: Female, Male
Sex: Female, Male(Participants)Active ColchicineActive PlaceboTotal
Female7777761553
Male8318251656
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Active ColchicineActive PlaceboTotal
Count of participants——0
Number of participants with stroke
Number of participants with stroke(Participants)Active ColchicineActive PlaceboTotal
Yes463985
No156215623124
Number of participants with myocardial infarction
Number of participants with myocardial infarction(Participants)Active ColchicineActive PlaceboTotal
Yes9073163
No151815283046
Number of participants with hypertension
Number of participants with hypertension(Participants)Active ColchicineActive PlaceboTotal
Yes8368321668
No7727691541
Number of patietns with aspirin taken within 24 h before surgery
Number of patietns with aspirin taken within 24 h before surgery(Participants)Active ColchicineActive PlaceboTotal
Yes155141296
No145314602913
Number of participants with ACE inhibitor or ARB taken within 24 h before surgery
Number of participants with ACE inhibitor or ARB taken within 24 h before surgery(Participants)Active ColchicineActive PlaceboTotal
Yes310305615
No129812962594

9 further baseline measures are reported on the registry.

08

Study locations

46 sites
  • Cleveland Clinic Florida
    Weston, Florida 33331, United States
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
  • Stony Brook University Hospital
    Stony Brook, New York 11794, United States
  • Wake Forest Baptist Medical Center
    Winston-Salem, North Carolina 27157, United States
  • Fairview Hospital
    Cleveland, Ohio 44111, United States
  • The Ohio State University Wexner Medical Center
    Columbus, Ohio 43210, United States
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
  • The University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • Vienna General Hospital
    Vienna, 1090, Austria
  • CHU Brugmann UVC
    Brussels, Brussels Capital 1020, Belgium
  • Hôpital Érasme
    Brussels, 1070, Belgium
  • Hôpital Civil Marie Curie
    Charleroi, 6042, Belgium
  • Foothills Medical Centre
    Calgary, Alberta T2N 2T9, Canada
  • Vancouver General Hospital
    Vancouver, British Columbia V5Z 1M9, Canada
  • Health Sciences Centre Winnipeg
    Winnipeg, Manitoba R3A 1R9, Canada
  • Victoria General Hospital
    Halifax, Nova Scotia B3H 2Y9, Canada
  • St. Joseph's Healthcare Hamilton
    Hamilton, Ontario L8N 4A6, Canada
  • Kingston General Hospital
    Kingston, Ontario K7L 2V7, Canada
  • Victoria Hospital
    London, Ontario N6A 5W9, Canada
  • The Ottawa Hospital General Campus
    Ottawa, Ontario K1H 8L6, Canada
  • Toronto General Hospital
    Toronto, Ontario M5G 2C4, Canada
  • St. Joseph's Health Centre
    Toronto, Ontario, Canada
  • Montreal General Hospital
    Montreal, Quebec H3G 1A4, Canada
  • Institut universitaire de cardiologie et de pneumologie de Québec
    Québec, Quebec G1V 4G5, Canada
  • CIUSSS de l'Estrie - CHUS
    Sherbrooke, Quebec J1H 5H3, Canada
  • Fundación Cardioinfantil y LaCardio
    Bogotá, Cundinamarca, Colombia
  • Prince of Wales Hospital
    Hong Kong, Hong Kong, Hong Kong
  • Tuen Mun Hospital
    Hong Kong, Hong Kong
  • Azienda Ospedaliero Universitaria Careggi
    Florence, Florence 50134, Italy
  • Ospedale Santa Maria della Misericordia
    Udine, Udine 33100, Italy
  • IRCCS Ospedale San Raffaele
    Milan, 20132, Italy
  • Fondazione Policlinico Universitario A. Gemelli IRCCS
    Roma, Italy
  • Azienda Ospedaliero-Universitaria Sant'Andrea
    Rome, 00189, Italy
  • Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
    Torino, 10126, Italy
  • Hospital Serdang
    Kajang, Selangor 43000, Malaysia
  • University of Malaya Medical Centre
    Kuala Lumpur, Selangor 59100, Malaysia
  • Shifa International Hospital
    Islamabad, Islamabad 44000, Pakistan
  • Hospital del Mar
    Barcelona, 08003, Spain
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, 08025, Spain
  • Hospital Universitari Sagrat Cor
    Barcelona, 08029, Spain
  • Hospital Vall d'Hebron
    Barcelona, 08035, Spain
  • Hospital Clínic de Barcelona
    Barcelona, 08036, Spain
  • Hospital Gregorio Maranon
    Madrid, 28007, Spain
  • Hospital Universitario Ramón y Cajal
    Madrid, 28034, Spain
  • Luzerner Kantonsspital
    Lucerne, Switzerland
  • Universitätsspital Zürich
    Zurich, 8091, Switzerland
09

References and documents

Publications

  • Conen D, Popova E, Wang MK, Chan MTV, Landoni G, Reimer C, Srinathan SK, Cata JP, McLean SR, Trujillo Reyes JC, Grande AM, Gonzalez Tallada A, Sessler DI, Fleischmann E, Maziak DE, Kabon B, Voltolini L, Gutierrez-Soriano L, Tandon V, DuMerton D, Kidane B, Rajaram R, Shargall Y, Neary JD, Wells JR, McIntyre WF, Blum S, Ofori SN, Vincent J, Xu L, Li Z, Healey JS, Garg AX, Devereaux PJ; COP-AF Investigators. Rationale and design of the colchicine for the prevention of perioperative atrial fibrillation in patients undergoing major noncardiac thoracic surgery (COP-AF) trial. Am Heart J. 2023 May;259:87-96. doi: 10.1016/j.ahj.2023.01.018. Epub 2023 Feb 7. PubMed 36754105 ↗
  • Conen D, Ke Wang M, Popova E, Chan MTV, Landoni G, Cata JP, Reimer C, McLean SR, Srinathan SK, Reyes JCT, Grande AM, Tallada AG, Sessler DI, Fleischmann E, Kabon B, Voltolini L, Cruz P, Maziak DE, Gutierrez-Soriano L, McIntyre WF, Tandon V, Martinez-Tellez E, Guerra-Londono JJ, DuMerton D, Wong RHL, McGuire AL, Kidane B, Roux DP, Shargall Y, Wells JR, Ofori SN, Vincent J, Xu L, Li Z, Eikelboom JW, Jolly SS, Healey JS, Devereaux PJ; COP-AF Investigators. Effect of colchicine on perioperative atrial fibrillation and myocardial injury after non-cardiac surgery in patients undergoing major thoracic surgery (COP-AF): an international randomised trial. Lancet. 2023 Nov 4;402(10413):1627-1635. doi: 10.1016/S0140-6736(23)01689-6. Epub 2023 Aug 25. PubMed 37640035 ↗
  • Ofori S, Wang MK, Popova E, McIntyre WF, Chan M, Sessler DI, Giulia V, Warwas M, Balasubramanian K, Tandon V, Finley C, Anna GT, Cata J, Srinathan S, Reimer C, McLean S, Trujillo JC, Fleischmann E, Voltolini L, Cruz P, Maziak DE, Gutierrez-Soriano L, Amir M, Bossard M, Wang CY, Devereaux PJ, Conen D; COP-AF investigators. Smoking, Colchicine and Postoperative Outcomes in Thoracic Surgery: Post Hoc Analysis of the COP-AF Randomized Controlled Trial. CJC Open. 2025 Apr 21;7(7):860-870. doi: 10.1016/j.cjco.2025.04.008. eCollection 2025 Jul. PubMed 40698308 ↗
  • Garg AX, Cuerden M, Cata J, Chan MTV, Devereaux PJ, Fleischmann E, Grande AM, Kabon B, Landoni G, Maziak DE, McLean S, Parikh C, Popova E, Reimer C, Trujillo Reyes JC, Roshanov P, Sessler DI, Srinathan S, Sontrop JM, Gonzalez Tallada A, Wang MK, Wells JR, Conen D. Effect of Colchicine on the Risk of Perioperative Acute Kidney Injury: Clinical Protocol of a Substudy of the Colchicine for the Prevention of Perioperative Atrial Fibrillation Randomized Clinical Trial. Can J Kidney Health Dis. 2023 Jul 11;10:20543581231185427. doi: 10.1177/20543581231185427. eCollection 2023. PubMed 37457622 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

1 registry update since Sep 25, 2026
Results
Results posted
posted Oct 16, 2026
Sites
9 sites added, 7 sites removed
Show 9 added (3 Italy, 2 Switzerland, 1 Belgium, 1 Canada, 1 Hong Kong, 1 Pakistan)
  • CHU Brugmann UVC · Brussels, Belgium
  • St. Joseph's Health Centre · Toronto, Canada
  • Prince of Wales Hospital · Hong Kong, Hong Kong
  • Azienda Ospedaliero Universitaria Careggi · Florence, Italy
  • Ospedale Santa Maria della Misericordia · Udine, Italy
  • Fondazione Policlinico Universitario A. Gemelli IRCCS · Roma, Italy
  • Shifa International Hospital · Islamabad, Pakistan
  • Luzerner Kantonsspital · Lucerne, Switzerland
  • Universitätsspital Zürich · Zurich, Switzerland
Show 7 removed
  • CHU Brugmann UVC · Brussels, Belgium
  • Prince of Wales Hospital · Hong Kong, Hong Kong
  • Azienda Ospedaliero Universitaria Careggi · Florence, Italy
  • Ospedale Santa Maria della Misericordia · Udine, Italy
  • Shifa International Hospital · Islamabad, Pakistan
  • Luzerner Kantonsspital · Luzern, Switzerland
  • Universitätsspital Zürich · Zürich, Switzerland
Oct 16, 2026
Primary completion
Jul 26, 2023→Jun 1, 2023
Oct 16, 2026
Study completion
Jul 26, 2023→Jun 23, 2023
Oct 16, 2026
Eligibility
13 exclusion criteria edited, 1 added, 1 removed
What changed in the criteria
Exclusion criteria
  • RemovedPatients will be excluded if they:
  • AddedWe will exclude patients who meet any of the following criteria:
  • Editedhavepatients with a prior history of documented atrial fibrillationAF;
  • Editedarepatients currently taking anti-arrhythmic medication other than β-blockers, calcium channels blockers or digoxin;
  • Editedarepatients undergoing minor thoracic interventions/procedures (i.e., minor chest-wall surgeries, chest tube insertions, or needle pleural/lung biopsies);
  • Editedhave a contraindicationpatients with contraindications to colchicine (i.e., allergy to colchicine, myelodysplastic disorders, or an estimated glomerular filtration rate less than [eGFR] <30 mL/min/1.73m);
  • Editedarepatients not expected to take oral medications for greater than >24 hours after surgery (e.g., esophagectomy);
  • Editedarepatients scheduled for lung transplantation;
  • Editedarepatients currently taking non-study colchicine before surgery;
  • Editedhavepatients with severe hepatic dysfunction;
  • Editedhavepatients with aplastic anemia;
  • Editedare a womanwomen of childbearing potential who is pregnant, breastfeeding, orare not taking effective contraception, pregnant or breast-feeding;
  • Editedpatients who 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* (While systemic administration of these medications is contraindicated, patients with local administration only (e.g., eye drops, creams) are eligible for the trial);
  • Editedare an human immunodeficiency virus (HIV patient) patients treated with antiretroviral therapy; or
  • ChangedBefore are scheduled for thoracoscopic lung wedge resection only.Now patients scheduled for thoracoscopic lung wedge resection only†. (Patients scheduled for multiple thoracoscopic lung wedge resection only are eligible for inclusion).
Oct 16, 2026
Interventions
Changed Colchicine→Active Colchicine; Placebo→Active Placebo. Arm changed Colchicine→Active Colchicine; Placebo→Active Placebo
Oct 16, 2026
Primary outcomes
2 edited
What changed in the outcomes
  • EditedNumber of Participants With Clinically important perioperative atrial fibrillation/atrial flutterImportant Perioperative Atrial FibrillationTime frame: 14 days of randomization → 14 days after randomisation
  • ChangedBefore Myocardial injury after noncardiac surgeryNow Number of Participants With Myocardial Injury After Non-cardiac Surgery (MINS)Time frame: 14 days of randomization → 14 days after randomisation
Oct 16, 2026
Documents
Oct 16, 2026
Publications
Results publication added: Conen D, Ke Wang M, Popova E, Chan MTV, Landoni G, Cata JP, Reimer C, McLean SR, Srinathan SK, Reyes JCT, Grande AM, Tallada AG, Sessler DI, Fleischmann E, Kab… PubMed 37640035 ↗. 2 publications citing this study linked from PubMed
Oct 16, 2026
Secondary outcomes
4 edited, 8 added, 4 removed
What changed in the outcomes
  • EditedFirst occurrenceNumber of the compositeParticipants With Composite of allAll-cause mortalityDeath, nonfatal myocardial infarctionNon-fatal Myocardial Infarction, or nonfatal strokeand Non-fatal StrokeTime frame: 14 days of randomization → 14 days after randomisation
  • EditedFirst occurrenceNumber of myocardial injury after noncardiac surgery not fulfillingParticipants With MINS Not Fulfilling the 4th universal definitionFourth Universal Definition of myocardial infarctionMyocardial InfarctionTime frame: 14 days of randomization → 14 days after randomisation
  • EditedFirst occurrenceNumber of myocardial infarctionParticipants With Myocardial InfarctionTime frame: 14 days of randomization → 14 days after randomisation
  • EditedTime to chest tube removalChest Tube Removal, DaysTime frame: 14 days of randomization → 14 days after randomisation
  • AddedNumber of Participants With Composite of All-cause Death, Non-fatal MINS, and Non-fatal StrokeTime frame: 14 days after randomisation
  • AddedDays in HospitalTime frame: 14 days after randomisation
  • AddedNights in Step-down UnitTime frame: 14 days after randomisation
  • AddedNights in Intensive Care UnitTime frame: 14 days after randomisation
  • RemovedFirst occurrence of the composite of all-cause mortality, nonfatal myocardial injury after noncardiac surgery, or nonfatal strokeTime frame: 14 days of randomization
  • RemovedDuration of stay in ICU, step-down, and in-hospitalTime frame: 14 days of randomization
  • Addedother outcomeTertiary Outcome: Number of Participants With All-cause DeathTime frame: 14 days after randomization
  • Addedother outcomeTertiary Outcome: Number of Participants With Deep Venous Thrombosis or Pulmonary EmbolismTime frame: 14 days after randomisation
  • Addedother outcomeTertiary Outcome: Number of Participants With Composite of Life-threatening or Major BleedingTime frame: 14 days after randomisation
  • Addedother outcomeTertiary Outcome: Days Alive and at HomeTime frame: 14 days after randomisation
  • Removedother outcomeSepsis or infectionTime frame: 14 days of randomization
  • Removedother outcomeNon-infectious diarrheaTime frame: 14 days of randomization
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    Results posted
    Documents Study protocol ↗ posted · Statistical analysis plan ↗ posted
    Publications Results publication added: Conen D, Ke Wang M, Popova E, Chan MTV, Landoni G, Cata JP, Reimer C, McLean SR, Srinathan SK, Reyes JCT, Grande AM, Tallada AG, Sessler DI, Fleischmann E, Kab… PubMed 37640035 ↗. 2 publications citing this study linked from PubMed
    9 sites added, 7 sites removed
    Show 9 added (3 Italy, 2 Switzerland, 1 Belgium, 1 Canada, 1 Hong Kong, 1 Pakistan)
    • CHU Brugmann UVC · Brussels, Belgium
    • St. Joseph's Health Centre · Toronto, Canada
    • Prince of Wales Hospital · Hong Kong, Hong Kong
    • Azienda Ospedaliero Universitaria Careggi · Florence, Italy
    • Ospedale Santa Maria della Misericordia · Udine, Italy
    • Fondazione Policlinico Universitario A. Gemelli IRCCS · Roma, Italy
    • Shifa International Hospital · Islamabad, Pakistan
    • Luzerner Kantonsspital · Lucerne, Switzerland
    • Universitätsspital Zürich · Zurich, Switzerland
    Show 7 removed
    • CHU Brugmann UVC · Brussels, Belgium
    • Prince of Wales Hospital · Hong Kong, Hong Kong
    • Azienda Ospedaliero Universitaria Careggi · Florence, Italy
    • Ospedale Santa Maria della Misericordia · Udine, Italy
    • Shifa International Hospital · Islamabad, Pakistan
    • Luzerner Kantonsspital · Luzern, Switzerland
    • Universitätsspital Zürich · Zürich, Switzerland
    Primary completion Jul 26, 2023→Jun 1, 2023
    Study completion Jul 26, 2023→Jun 23, 2023
    Eligibility 13 exclusion criteria edited, 1 added, 1 removed
    What changed in the criteria
    Exclusion criteria
    • RemovedPatients will be excluded if they:
    • AddedWe will exclude patients who meet any of the following criteria:
    • Editedhavepatients with a prior history of documented atrial fibrillationAF;
    • Editedarepatients currently taking anti-arrhythmic medication other than β-blockers, calcium channels blockers or digoxin;
    • Editedarepatients undergoing minor thoracic interventions/procedures (i.e., minor chest-wall surgeries, chest tube insertions, or needle pleural/lung biopsies);
    • Editedhave a contraindicationpatients with contraindications to colchicine (i.e., allergy to colchicine, myelodysplastic disorders, or an estimated glomerular filtration rate less than [eGFR] <30 mL/min/1.73m);
    • Editedarepatients not expected to take oral medications for greater than >24 hours after surgery (e.g., esophagectomy);
    • Editedarepatients scheduled for lung transplantation;
    • Editedarepatients currently taking non-study colchicine before surgery;
    • Editedhavepatients with severe hepatic dysfunction;
    • Editedhavepatients with aplastic anemia;
    • Editedare a womanwomen of childbearing potential who is pregnant, breastfeeding, orare not taking effective contraception, pregnant or breast-feeding;
    • Editedpatients who 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* (While systemic administration of these medications is contraindicated, patients with local administration only (e.g., eye drops, creams) are eligible for the trial);
    • Editedare an human immunodeficiency virus (HIV patient) patients treated with antiretroviral therapy; or
    • ChangedBefore are scheduled for thoracoscopic lung wedge resection only.Now patients scheduled for thoracoscopic lung wedge resection only†. (Patients scheduled for multiple thoracoscopic lung wedge resection only are eligible for inclusion).
    Primary outcomes 2 edited
    What changed in the outcomes
    • EditedNumber of Participants With Clinically important perioperative atrial fibrillation/atrial flutterImportant Perioperative Atrial FibrillationTime frame: 14 days of randomization → 14 days after randomisation
    • ChangedBefore Myocardial injury after noncardiac surgeryNow Number of Participants With Myocardial Injury After Non-cardiac Surgery (MINS)Time frame: 14 days of randomization → 14 days after randomisation
    Secondary outcomes 4 edited, 8 added, 4 removed
    What changed in the outcomes
    • EditedFirst occurrenceNumber of the compositeParticipants With Composite of allAll-cause mortalityDeath, nonfatal myocardial infarctionNon-fatal Myocardial Infarction, or nonfatal strokeand Non-fatal StrokeTime frame: 14 days of randomization → 14 days after randomisation
    • EditedFirst occurrenceNumber of myocardial injury after noncardiac surgery not fulfillingParticipants With MINS Not Fulfilling the 4th universal definitionFourth Universal Definition of myocardial infarctionMyocardial InfarctionTime frame: 14 days of randomization → 14 days after randomisation
    • EditedFirst occurrenceNumber of myocardial infarctionParticipants With Myocardial InfarctionTime frame: 14 days of randomization → 14 days after randomisation
    • EditedTime to chest tube removalChest Tube Removal, DaysTime frame: 14 days of randomization → 14 days after randomisation
    • AddedNumber of Participants With Composite of All-cause Death, Non-fatal MINS, and Non-fatal StrokeTime frame: 14 days after randomisation
    • AddedDays in HospitalTime frame: 14 days after randomisation
    • AddedNights in Step-down UnitTime frame: 14 days after randomisation
    • AddedNights in Intensive Care UnitTime frame: 14 days after randomisation
    • RemovedFirst occurrence of the composite of all-cause mortality, nonfatal myocardial injury after noncardiac surgery, or nonfatal strokeTime frame: 14 days of randomization
    • RemovedDuration of stay in ICU, step-down, and in-hospitalTime frame: 14 days of randomization
    • Addedother outcomeTertiary Outcome: Number of Participants With All-cause DeathTime frame: 14 days after randomization
    • Addedother outcomeTertiary Outcome: Number of Participants With Deep Venous Thrombosis or Pulmonary EmbolismTime frame: 14 days after randomisation
    • Addedother outcomeTertiary Outcome: Number of Participants With Composite of Life-threatening or Major BleedingTime frame: 14 days after randomisation
    • Addedother outcomeTertiary Outcome: Days Alive and at HomeTime frame: 14 days after randomisation
    • Removedother outcomeSepsis or infectionTime frame: 14 days of randomization
    • Removedother outcomeNon-infectious diarrheaTime frame: 14 days of randomization
    Interventions Changed Colchicine→Active Colchicine; Placebo→Active Placebo. Arm changed Colchicine→Active Colchicine; Placebo→Active Placebo
    + 4 other changes: verification date, design details, data sharing statement and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT03310125
Lead sponsor
Population Health Research Institute
Collaborators
Hamilton Health Sciences Corporation
Responsible party
Sponsor
First posted
Oct 16, 2017
Start date
Feb 14, 2018
Primary completion
Jun 1, 2023
Completion
Jun 23, 2023
Results posted
Oct 16, 2026
Last update
Oct 16, 2026

Study contacts

David Conen, MD, MPH
principal investigator · Population Health Research Institute
PJ Devereaux, MD, PhD
study chair · Population Health Research Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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