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Colchicine For Prevention of Perioperative Atrial Fibrillation in Patients Undergoing Thoracic Surgery Pilot Study (COP-AF Pilot)

Primary Purpose

Atrial Fibrillation, Thoracic Surgery

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Colchicine 0.6 mg
Placebo Colchicine
Sponsored by
Population Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Manitoba Health Sciences Centre
  • St. Joseph Healthcare, St. Joseph Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Colchicine

Placebo Colchicine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Death
New Onset Atrial Flutter
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)
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
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.
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 Infection

Full Information

First Posted
November 8, 2013
Last Updated
November 3, 2021
Sponsor
Population Health Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01985425
Brief Title
Colchicine For Prevention of Perioperative Atrial Fibrillation in Patients Undergoing Thoracic Surgery Pilot Study
Acronym
COP-AF Pilot
Official Title
Colchicine For Prevention of Perioperative Atrial Fibrillation in Patients Undergoing Thoracic Surgery Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Population Health Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Thoracic Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Colchicine
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Colchicine
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Colchicine 0.6 mg
Other Intervention Name(s)
Brand names: PMS Colchicine, Colchicine TAB 0.6 mg
Intervention Type
Drug
Intervention Name(s)
Placebo Colchicine
Primary Outcome Measure Information:
Title
Clinically Significant Atrial Fibrillation
Description
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 Outcome Measure Information:
Title
Death
Time Frame
Post-operative Day 1 until Postoperative Day 30
Title
New Onset Atrial Flutter
Description
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
Title
Myocardial Injury After Non-Cardiac Surgery (MINS)
Description
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
Time Frame
Post-operative Day 1 until Postoperative Day 30
Title
Stroke
Description
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.
Time Frame
Post-operative Day 1 until Postoperative Day 30
Title
Transient Ischemic Attack (TIA)
Description
New focal neurological deficit thought to be vascular in origin with signs and symptoms lasting less than 24 hours.
Time Frame
Post-operative Day 1 until Postoperative Day 30
Title
Post-operative Infection
Time Frame
Post-operative Day 1 until Postoperative Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PJ Devereaux, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
St. Joseph Healthcare, St. Joseph Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada

12. IPD Sharing Statement

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

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