Colchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery (COP-AF) (COP-AF)
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| ClinicalTrials.gov Identifier: NCT03310125 |
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Recruitment Status :
Completed
First Posted : October 16, 2017
Last Update Posted : August 7, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atrial Fibrillation Atrial Flutter Myocardial Injury After Non-Cardiac Surgery | Drug: Colchicine Drug: Placebo | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 3209 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Colchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery (COP-AF) |
| Actual Study Start Date : | February 14, 2018 |
| Actual Primary Completion Date : | July 26, 2023 |
| Actual Study Completion Date : | July 26, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Colchicine
Participants received over-encapsulated colchicine 0.5 mg tablet orally twice daily for 10 days.
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Drug: Colchicine
Over-encapsulated 0.5mg tablet twice daily |
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Placebo Comparator: Placebo
Participants received matching placebo capsules orally twice daily for 10 days.
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Drug: Placebo
Matching placebo capsule twice daily |
- Clinically important perioperative atrial fibrillation/atrial flutter [ Time Frame: 14 days of randomization ]
- Myocardial injury after noncardiac surgery [ Time Frame: 14 days of randomization ]
- First occurrence of the composite of all-cause mortality, nonfatal myocardial injury after noncardiac surgery, or nonfatal stroke [ Time Frame: 14 days of randomization ]
- First occurrence of the composite of all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke [ Time Frame: 14 days of randomization ]
- First occurrence of myocardial injury after noncardiac surgery not fulfilling the 4th universal definition of myocardial infarction [ Time Frame: 14 days of randomization ]
- First occurrence of myocardial infarction [ Time Frame: 14 days of randomization ]
- Time to chest tube removal [ Time Frame: 14 days of randomization ]
- Duration of stay in ICU, step-down, and in-hospital [ Time Frame: 14 days of randomization ]
- Sepsis or infection [ Time Frame: 14 days of randomization ]Safety outcome
- Non-infectious diarrhea [ Time Frame: 14 days of randomization ]Safety outcome
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| Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients are eligible if they:
- are undergoing thoracic surgery with general anesthesia;
- are greater than or equal to 55 years of age at the time of randomization;
- are expected to require at least an overnight hospital admission after surgery; and
- provide written informed consent to participate.
Exclusion Criteria:
Patients will be excluded if they:
- have a prior history of documented atrial fibrillation;
- are currently taking anti-arrhythmic medication other than β-blockers, calcium channels blockers or digoxin;
- are undergoing minor thoracic interventions/procedures (i.e., minor chest-wall surgeries, chest tube insertions, or needle pleural/lung biopsies);
- 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);
- are not expected to take oral medications for greater than 24 hours after surgery (e.g., esophagectomy);
- are scheduled for lung transplantation;
- are currently taking non-study colchicine before surgery;
- have severe hepatic dysfunction;
- have aplastic anemia;
- are a woman of childbearing potential who is pregnant, breastfeeding, or not taking effective contraception;
- 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;
- are an HIV patient treated with antiretroviral therapy; or
- are scheduled for thoracoscopic lung wedge resection only.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310125
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| Principal Investigator: | David Conen, MD, MPH | Population Health Research Institute | |
| Study Chair: | PJ Devereaux, MD, PhD | Population Health Research Institute |
| Responsible Party: | Population Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT03310125 |
| Other Study ID Numbers: |
2017-001-COPAF |
| First Posted: | October 16, 2017 Key Record Dates |
| Last Update Posted: | August 7, 2023 |
| Last Verified: | August 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Atrial Fibrillation Inflammation Thoracic Surgery |
Randomized Colchicine Myocardial Injury |
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Atrial Fibrillation Atrial Flutter Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Colchicine |
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