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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01985425
Recruitment Status : Completed
First Posted : November 15, 2013
Results First Posted : January 23, 2017
Last Update Posted : November 5, 2021
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Thoracic Surgery Drug: Colchicine 0.6 mg Drug: Placebo Colchicine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Colchicine For Prevention of Perioperative Atrial Fibrillation in Patients Undergoing Thoracic Surgery Pilot Study.
Study Start Date : April 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

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 Name: 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



Primary Outcome Measures :
  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 Outcome Measures :
  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:

    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


  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985425


Locations
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Canada, Manitoba
University of Manitoba Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
St. Joseph Healthcare, St. Joseph Hospital
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Population Health Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: PJ Devereaux, PhD McMaster University
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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT01985425    
Other Study ID Numbers: COP-AF Pilot
First Posted: November 15, 2013    Key Record Dates
Results First Posted: January 23, 2017
Last Update Posted: November 5, 2021
Last Verified: November 2021
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents