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

November 3, 2021 updated by: Population Health Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • University of Manitoba Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph Healthcare, St. Joseph Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Active Colchicine
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
Other Names:
  • Brand names: PMS Colchicine, Colchicine TAB 0.6 mg
PLACEBO_COMPARATOR: 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.
Drug: Placebo Colchicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post-operative Day 1 until Postoperative Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: Post-operative Day 1 until Postoperative Day 30
Post-operative Day 1 until Postoperative Day 30
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.
Post-operative Day 1 until Postoperative Day 30
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:

  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
Post-operative Day 1 until Postoperative Day 30
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.
Post-operative Day 1 until Postoperative Day 30
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.
Post-operative Day 1 until Postoperative Day 30
Post-operative Infection
Time Frame: Post-operative Day 1 until Postoperative Day 30
Post-operative Day 1 until Postoperative Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Population Health Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: PJ Devereaux, PhD, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

November 8, 2013

First Submitted That Met QC Criteria

November 8, 2013

First Posted (ESTIMATE)

November 15, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2021

Last Update Submitted That Met QC Criteria

November 3, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COP-AF Pilot

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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