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Completed

NCT Number: NCT01985425

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Thoracic Surgery

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Manitoba Health Sciences Centre, Winnipeg, Manitoba, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colchicine 0.6 mg

Drug

Other names: Brand names: PMS Colchicine, Colchicine TAB 0.6 mg

Placebo Colchicine

Drug

Primary outcomes

  1. Clinically Significant Atrial Fibrillation

    Time frame: 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 outcomes

  1. Death

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

  2. New Onset Atrial Flutter

    Time frame: 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.

  3. Myocardial Injury After Non-Cardiac Surgery (MINS)

    Time frame: 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:

    • 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

  4. Stroke

    Time frame: 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.

  5. Transient Ischemic Attack (TIA)

    Time frame: 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.

  6. Post-operative Infection

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

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Acronym: COP-AF Pilot

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 15, 2013
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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