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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine 0.6 mg | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Post-operative Day 1 until Postoperative Day 30 | |
| New Onset Atrial Flutter | Replacement of the consistent P waves on 12-lead ECG, or documented telemetry tracing, by saw-tooth flutter waves. |
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Inclusion Criteria:
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)
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| Name | Affiliation | Role |
|---|---|---|
| PJ Devereaux, PhD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Manitoba Health Sciences Centre | Winnipeg | Manitoba | R3A 1R9 | Canada | ||
| St. Joseph Healthcare, St. Joseph Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. Colchicine Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Post-operative Day 1 until Postoperative Day 30 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Philip Devereaux | Population Health Research Institute | 905-527-4322 | 40654 | philipj@mcmaster.ca |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Placebo Colchicine |
| Drug |
|
| Post-operative Day 1 until Postoperative Day 30 |
| 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:
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 |
| 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 |
| 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 |
| Post-operative Infection | Post-operative Day 1 until Postoperative Day 30 |
| Hamilton |
| Ontario |
| L8N 4A6 |
| Canada |
| BG001 |
| 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. Colchicine Placebo |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. Colchicine Placebo |
|
|
| Secondary | Death | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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:
B) Elevated troponin measurement after surgery with no alternative explanation (e.g., pulmonary embolism, sepsis) to myocardial injury | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | Post-operative Day 1 until Postoperative Day 30 |
|
|
|
| Secondary | Post-operative Infection | Posted | Count of Participants | Participants | Post-operative Day 1 until Postoperative Day 30 |
|
|
|
| 3 |
| 49 |
| 0 |
| 49 |
| EG001 | 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. Colchicine Placebo | 3 | 51 | 0 | 51 |
| fall | Nervous system disorders |
|
| unconsciousness | Cardiac disorders |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |