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

NCT01985425 | Completed Phase 3 Results

• 1 other identifier: COP-AF Pilot
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Atrial Fibrillation; Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  Post-operative Day 1 until Postoperative Day 30

Secondary Outcomes (6)

• Death

  Post-operative Day 1 until Postoperative Day 30

• New Onset Atrial Flutter

  Post-operative Day 1 until Postoperative Day 30

• Myocardial Injury After Non-Cardiac Surgery (MINS)

  Post-operative Day 1 until Postoperative Day 30

• Stroke

  Post-operative Day 1 until Postoperative Day 30

• Transient Ischemic Attack (TIA)

  Post-operative Day 1 until Postoperative Day 30

Study Arms (2)

Active Colchicine

EXPERIMENTAL

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

Placebo Colchicine

PLACEBO COMPARATOR

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

Interventions

Colchicine 0.6 mg DRUG

Also known as: Brand names: PMS Colchicine, Colchicine TAB 0.6 mg

Active Colchicine

Placebo Colchicine DRUG

Placebo Colchicine

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients ≥55 years of age undergoing intra-thoracic surgery for a resection of tumor in lung.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Population Health Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

University of Manitoba Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

St. Joseph Healthcare, St. Joseph Hospital

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Philip Devereaux
• Organization: Population Health Research Institute

philipj@mcmaster.ca

905-527-4322

Study Officials

• PJ Devereaux, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: November 15, 2013
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 5, 2021
• Results First Posted: January 23, 2017

Record last verified: 2021-11

Locations

CA (2)