Colchicine For Prevention of Perioperative Atrial Fibrillation in Patients Undergoing Thoracic Surgery Pilot Study

Study Overview
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Brief Summary
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The purpose of this pilot study is to determine the feasibility of comparing colchicine to placebo for the prevention of new onset atrial fibrillation in patients undergoing general thoracic surgery and establish the foundation for a large, multi-centre, clinical trial.

Official Title
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Colchicine For Prevention of Perioperative Atrial Fibrillation in Patients Undergoing Thoracic Surgery Pilot Study.

Conditions
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Atrial Fibrillation, Thoracic Surgery

Intervention / Treatment
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* Drug: Colchicine 0.6 mg
* Drug: Placebo Colchicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients ≥55 years of age undergoing intra-thoracic surgery for a resection of tumor in lung. Exclusion Criteria: In AF prior to surgery*, Undergoing minor thoracic interventions/ procedures (i.e., chest tube insertion, needle pleural/lung biopsies, or minor chest-wall surgeries), or With contraindications to colchicine (i.e., allergy, or myelodysplastic disorders or estimated glomerular filtration rate [e-GFR] <30 mL/min/1.73m) Clarification: Patients with history of AF who are in sinus rhythm during enrollment will be eligible for recruitment. Patients who have no history of AF and are found to be in AF at the time of enrollment will not be eligible.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Colchicine<br>On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days. | Drug: Colchicine 0.6 mg<br> <br> * Other names: Brand names: PMS Colchicine, Colchicine TAB 0.6 mg;|
| Placebo Comparator: Placebo Colchicine<br>On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days. | Drug: Placebo Colchicine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically Significant Atrial Fibrillation | New atrial fibrillation that results in angina, congestive heart failure, symptomatic hypotension, or that requires treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion, or that lasts for longer than 30 seconds. | Post-operative Day 1 until Postoperative Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | Post-operative Day 1 until Postoperative Day 30 | 
| New Onset Atrial Flutter | Replacement of the consistent P waves on 12-lead ECG, or documented telemetry tracing, by saw-tooth flutter waves. | Post-operative Day 1 until Postoperative Day 30 | 
| Myocardial Injury After Non-Cardiac Surgery (MINS) | Requires one of the following criteria: A) Elevated troponin or CK-MB measurement with one or more of the following defining features: Ischemic signs or symptoms (i.e., chest, arm, neck, or jaw discomfort; shortness of breath, pulmonary edema); Development of pathologic Q waves present in any two contiguous leads that are >30 milliseconds; Electrocardiogram (ECG) changes indicative of ischemia (i.e., ST segment elevation [>2 mm in leads V1, V2, or V3 OR >1 mm in the other leads], ST segment depression [>1 mm], OR symmetric inversion of T waves >1 mm) in at least two contiguous leads; New LBBB; or v. new or presumed new cardiac wall motion abnormality on echocardiography or new or presumed new fixed defect on radionuclide imaging; B) Elevated troponin measurement after surgery with no alternative explanation (e.g., pulmonary embolism, sepsis) to myocardial injury | Post-operative Day 1 until Postoperative Day 30 | 
| Stroke | New focal neurological deficit thought to be vascular in origin with signs and symptoms lasting more than 24 hours and cerebral imaging consistent with acute stroke. | Post-operative Day 1 until Postoperative Day 30 | 
| Transient Ischemic Attack (TIA) | New focal neurological deficit thought to be vascular in origin with signs and symptoms lasting less than 24 hours. | Post-operative Day 1 until Postoperative Day 30 | 
| Post-operative Infection |  | Post-operative Day 1 until Postoperative Day 30 |