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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01985425

Acronym

COP-AF Pilot

Enrollment

100

Registered

2013-11-15

Start date

2014-04-30

Completion date

2015-09-30

Last updated

2021-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Thoracic Surgery

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.

Interventions

DRUGColchicine 0.6 mg

DRUGPlacebo Colchicine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Clinically Significant Atrial Fibrillation	Post-operative Day 1 until Postoperative Day 30	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.

Secondary

Measure	Time frame	Description
New Onset Atrial Flutter	Post-operative Day 1 until Postoperative Day 30	Replacement of the consistent P waves on 12-lead ECG, or documented telemetry tracing, by saw-tooth flutter waves.
Myocardial Injury After Non-Cardiac Surgery (MINS)	Post-operative Day 1 until Postoperative Day 30	Requires one of the following criteria: A) Elevated troponin or CK-MB measurement with one or more of the following defining features: 1. Ischemic signs or symptoms (i.e., chest, arm, neck, or jaw discomfort; shortness of breath, pulmonary edema); 2. Development of pathologic Q waves present in any two contiguous leads that are \>30 milliseconds; 3. 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; 4. 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
Death	Post-operative Day 1 until Postoperative Day 30	—
Transient Ischemic Attack (TIA)	Post-operative Day 1 until Postoperative Day 30	New focal neurological deficit thought to be vascular in origin with signs and symptoms lasting less than 24 hours.
Post-operative Infection	Post-operative Day 1 until Postoperative Day 30	—
Stroke	Post-operative Day 1 until Postoperative Day 30	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.

Countries

Canada

Participant flow

Participants by arm

Arm	Count
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	49
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	51
Total	100

Baseline characteristics

Characteristic	Placebo Colchicine	Active Colchicine	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	33 Participants	32 Participants	65 Participants
Age, Categorical Between 18 and 65 years	18 Participants	17 Participants	35 Participants
Age, Continuous	68.28 years STANDARD_DEVIATION 7.4	68.89 years STANDARD_DEVIATION 7.5	68.57 years STANDARD_DEVIATION 7.4
Region of Enrollment Canada	51 participants	49 participants	100 participants
Sex: Female, Male Female	22 Participants	33 Participants	55 Participants
Sex: Female, Male Male	29 Participants	16 Participants	45 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 49	0 / 51
serious Total, serious adverse events	3 / 49	3 / 51

Outcome results

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.