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

Phase 3

Completed

• Conditions: Atrial Fibrillation; Thoracic Surgery
• Interventions: Drug: Placebo Colchicine; Drug: Colchicine 0.6 mg

• Registration Number: NCT01985425
• Lead Sponsor: Population Health Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-08
• Study First Submitted QC: 2013-11-08
• Study First Posted: 2013-11-15
• Study Start: 2014-04
• Primary Completion: 2015-04
• Study Completion: 2015-09
• Results First Submitted: 2016-11-25
• Results First Submitted QC: 2016-11-25
• Results First Posted: 2017-01-23
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-03
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Colchicine	Placebo Colchicine	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.
Active Colchicine	Colchicine 0.6 mg	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.

Primary Outcome Measures

Name	Time	Method
Clinically Significant Atrial Fibrillation	Post-operative Day 1 until Postoperative Day 30	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.

Secondary Outcome Measures

Name	Time	Method
Death	Post-operative Day 1 until Postoperative Day 30
New Onset Atrial Flutter	Post-operative Day 1 until Postoperative Day 30	Replacement of the consistent P waves on 12-lead ECG, or documented telemetry tracing, by saw-tooth flutter waves.
Myocardial Injury After Non-Cardiac Surgery (MINS)	Post-operative Day 1 until Postoperative Day 30	Requires one of the following criteria: A) Elevated troponin or CK-MB measurement with one or more of the following defining features: 1. Ischemic signs or symptoms (i.e., chest, arm, neck, or jaw discomfort; shortness of breath, pulmonary edema); 2. Development of pathologic Q waves present in any two contiguous leads that are \>30 milliseconds; 3. 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; 4. 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
Stroke	Post-operative Day 1 until Postoperative Day 30	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.
Transient Ischemic Attack (TIA)	Post-operative Day 1 until Postoperative Day 30	New focal neurological deficit thought to be vascular in origin with signs and symptoms lasting less than 24 hours.
Post-operative Infection	Post-operative Day 1 until Postoperative Day 30

Trial Locations

Locations (2)

St. Joseph Healthcare, St. Joseph Hospital; 🇨🇦 Hamilton, Ontario, Canada

University of Manitoba Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada