The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery

COlchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery - COP-AF

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003836-35-IT

Enrollment

2800

Registered

2020-10-07

Start date

2020-07-29

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative atrial fibrillation / atrial flutter after thoracic surgery MedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: COLCHICINE TIOFARMA 0.5mg tablets Product Name: colchicine 0.5mg Product Code: [RVG21347] Pharmaceutical Form: Tablet INN or Proposed INN: COLCHICINA Current Sponsor code: NA Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients undergoing thoracic surgery with general anesthesia are eligible for the trial if they are =55 years of age at the time of randomization and expected to require at least an overnight hospital admission after surgery. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 980 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1820

Exclusion criteria

Exclusion criteria: 1. patients with a prior history of documented AF; 2. patients currently taking anti-arrhythmic medication other than ß-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 biopsies); 4. patients with contraindications to colchicine (i.e., allergy to colchicine, myelodysplastic disorders, or an estimated glomerular filtration rate [eGFR] 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 childbearing potential who are not taking effective contraception, 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 during the first 10 days after surgery; OR 12. HIV patients treated with antiretroviral therapy;

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this trial is to determine whether the administration of colchicine compared with placebo reduces the occurrence of perioperative atrial fibrillation / atrial flutter (AF) within 14 days of randomization.;Secondary Objective: The secondary trial objectives are to determine whether the administration of colchicine compared with placebo reduces the: 1. first occurrence of the composite of all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke within 14 days of randomization; 2. duration of stay in ICU, step-down, and in-hospital; 3. all-cause mortality within 14 days of randomization; 4. occurrence of myocardial infarction within 14 days of randomization. 5. occurrence of myocardial injury after noncardiac surgery;;Primary end point(s): Clinically important perioperative atrial fibrillation, defined as atrial fibrillation developing after randomization until the end of follow-up, and that results in angina, heart failure, symptomatic hypotension, or that requires treatment with a rate controlling drug, antiarrhythmic drug or electrical cardioversion.;Timepoint(s) of evaluation of this end point: Evaluation at 14 days after randomization.	—

Measure

Time frame

Main Objective: The primary objective of this trial is to determine whether the administration of colchicine compared with placebo reduces the occurrence of perioperative atrial fibrillation / atrial flutter (AF) within 14 days of randomization.;Secondary Objective: The secondary trial objectives are to determine whether the administration of colchicine compared with placebo reduces the: 1. first occurrence of the composite of all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke within 14 days of randomization; 2. duration of stay in ICU, step-down, and in-hospital; 3. all-cause mortality within 14 days of randomization; 4. occurrence of myocardial infarction within 14 days of randomization. 5. occurrence of myocardial injury after noncardiac surgery;;Primary end point(s): Clinically important perioperative atrial fibrillation, defined as atrial fibrillation developing after randomization until the end of follow-up, and that results in angina, heart failure, symptomatic hypotension, or that requires treatment with a rate controlling drug, antiarrhythmic drug or electrical cardioversion.;Timepoint(s) of evaluation of this end point: Evaluation at 14 days after randomization.

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Secondary

Measure	Time frame
Secondary end point(s): 1. first occurrence of the composite of all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke within 14 days of randomization; 2. occurrence of myocardial injury after noncardiac surgery; 3. number of days alive and at home; 4. time to chest tube removal within 14 days of randomization. 5. duration of stay in ICU, step-down, and in-hospital; 6. all-cause mortality within 14 days of randomization; and 7. occurrence of myocardial infarction within 14 days of randomization;Timepoint(s) of evaluation of this end point: Evaluation at 14 days after randomization	—

Measure

Time frame

Secondary end point(s): 1. first occurrence of the composite of all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke within 14 days of randomization; 2. occurrence of myocardial injury after noncardiac surgery; 3. number of days alive and at home; 4. time to chest tube removal within 14 days of randomization. 5. duration of stay in ICU, step-down, and in-hospital; 6. all-cause mortality within 14 days of randomization; and 7. occurrence of myocardial infarction within 14 days of randomization;Timepoint(s) of evaluation of this end point: Evaluation at 14 days after randomization

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Countries

Australia, Austria, Belgium, Canada, Germany, Hong Kong, Hungary, Italy, Malaysia, Netherlands, Pakistan, Poland, Russian Federation, South Africa, Spain, Switzerland, United States

Contacts

Public ContactAnestesia e Rianimazione Cardio-Tor

IRCCS OSPEDALE SAN RAFFAELE

landoni.giovanni@hsr.it0226436155

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026