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| Name | Class |
|---|---|
| Hamilton Health Sciences Corporation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine | Experimental | Participants received over-encapsulated colchicine 0.5 mg tablet orally twice daily for 10 days. |
|
| Placebo | Placebo Comparator | Participants received matching placebo capsules orally twice daily for 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | Over-encapsulated 0.5mg tablet twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically important perioperative atrial fibrillation/atrial flutter | 14 days of randomization | |
| Myocardial injury after noncardiac surgery | 14 days of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 the composite of all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke |
| Measure | Description | Time Frame |
|---|---|---|
| Sepsis or infection | Safety outcome | 14 days of randomization |
| Non-infectious diarrhea | Safety outcome | 14 days of randomization |
Inclusion Criteria:
Patients are eligible if they:
Exclusion Criteria:
Patients will be excluded if they:
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| Name | Affiliation | Role |
|---|---|---|
| David Conen, MD, MPH | Population Health Research Institute | Principal Investigator |
| PJ Devereaux, MD, PhD | Population Health Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States | ||
| Henry Ford Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40698308 | Derived | 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. | |
| 37640035 |
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| Placebo |
| Drug |
Matching placebo capsule twice daily |
|
| 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 |
| First occurrence of myocardial infarction | 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 |
| 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 | 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 |
| 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 |
| Tuen Mun Hospital | Hong Kong | Hong Kong |
| Azienda Ospedaliero Universitaria Careggi | Florence | 50134 | Italy |
| IRCCS Ospedale San Raffaele | Milan | 20132 | Italy |
| Azienda Ospedaliero-Universitaria Sant'Andrea | Rome | 00189 | Italy |
| Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino | Torino | 10126 | Italy |
| Ospedale Santa Maria della Misericordia | Udine | 33100 | 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 |
| Derived |
| 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. |
| 37457622 | Derived | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 19, 2025 | Jul 7, 2025 | 10 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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