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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01985425
Other study ID # COP-AF Pilot
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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