Colchicine For Prevention of Perioperative Atrial Fibrillation in Patients Undergoing Thoracic Surgery Pilot Study
NCT ID: NCT01985425
Last Updated: 2021-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2014-04-30
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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.
Colchicine 0.6 mg
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.
Placebo Colchicine
Interventions
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Colchicine 0.6 mg
Placebo Colchicine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
55 Years
ALL
Yes
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Population Health Research Institute
OTHER
Responsible Party
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Principal Investigators
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PJ Devereaux, PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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University of Manitoba Health Sciences Centre
Winnipeg, Manitoba, Canada
St. Joseph Healthcare, St. Joseph Hospital
Hamilton, Ontario, Canada
Countries
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Other Identifiers
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COP-AF Pilot
Identifier Type: -
Identifier Source: org_study_id