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

Atrial Fibrillation Clinical Trial

— COP-AF Pilot  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01985425
• Other study ID #: COP-AF Pilot
• Status: Completed
• Phase: Phase 3
• Start date: April 2014
• Est. completion date: September 2015

Study information

• Verified date: November 2021
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Thoracic Surgery

Intervention

Drug:
• Colchicine 0.6 mg

• Placebo Colchicine

Locations

Country	Name	City	State
Canada	St. Joseph Healthcare, St. Joseph Hospital	Hamilton	Ontario
Canada	University of Manitoba Health Sciences Centre	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Population Health Research Institute	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Death		Post-operative Day 1 until Postoperative Day 30
Secondary	New Onset Atrial Flutter	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
Secondary	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	Post-operative Day 1 until Postoperative Day 30
Secondary	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.	Post-operative Day 1 until Postoperative Day 30
Secondary	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 Day 1 until Postoperative Day 30
Secondary	Post-operative Infection		Post-operative Day 1 until Postoperative Day 30