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

Phase 3CompletedNCT01985425

Population Health Research Institute100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

100

Conditions

Atrial Fibrillation Thoracic Surgery

Interventions

Colchicine 0.6 mgDRUG

Placebo ColchicineDRUG

Eligibility

Sex: ALLMin age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

University of Manitoba Health Sciences Centre

Winnipeg, Manitoba, Canada

St. Joseph Healthcare, St. Joseph Hospital

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: Post-operative Day 1 until Postoperative Day 30

Secondary Outcomes

Death

Time frame: 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.

Time frame: 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: 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

Time frame: 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.

Data from ClinicalTrials.gov

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