Trial Outcomes & Findings for Colchicine For Prevention of Perioperative Atrial Fibrillation in Patients Undergoing Thoracic Surgery Pilot Study (NCT NCT01985425)
NCT ID: NCT01985425
Last Updated: 2021-11-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
100 participants
Primary outcome timeframe
Post-operative Day 1 until Postoperative Day 30
Results posted on
2021-11-05
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
51
|
|
Overall Study
COMPLETED
|
49
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Colchicine For Prevention of Perioperative Atrial Fibrillation in Patients Undergoing Thoracic Surgery Pilot Study
Baseline characteristics by cohort
| Measure |
Active Colchicine
n=49 Participants
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
|
Placebo Colchicine
n=51 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
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Age, Continuous
|
68.89 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
68.28 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
68.57 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
49 participants
n=5 Participants
|
51 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-operative Day 1 until Postoperative Day 30New 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.
Outcome measures
| Measure |
Active Colchicine
n=49 Participants
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
|
Placebo Colchicine
n=51 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
|
|---|---|---|
|
Clinically Significant Atrial Fibrillation
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Post-operative Day 1 until Postoperative Day 30Outcome measures
| Measure |
Active Colchicine
n=49 Participants
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
|
Placebo Colchicine
n=51 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
|
|---|---|---|
|
Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post-operative Day 1 until Postoperative Day 30Replacement of the consistent P waves on 12-lead ECG, or documented telemetry tracing, by saw-tooth flutter waves.
Outcome measures
| Measure |
Active Colchicine
n=49 Participants
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
|
Placebo Colchicine
n=51 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
|
|---|---|---|
|
New Onset Atrial Flutter
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Post-operative Day 1 until Postoperative Day 30Requires 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
Outcome measures
| Measure |
Active Colchicine
n=49 Participants
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
|
Placebo Colchicine
n=51 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
|
|---|---|---|
|
Myocardial Injury After Non-Cardiac Surgery (MINS)
|
10 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Post-operative Day 1 until Postoperative Day 30New 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.
Outcome measures
| Measure |
Active Colchicine
n=49 Participants
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
|
Placebo Colchicine
n=51 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
|
|---|---|---|
|
Stroke
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post-operative Day 1 until Postoperative Day 30New focal neurological deficit thought to be vascular in origin with signs and symptoms lasting less than 24 hours.
Outcome measures
| Measure |
Active Colchicine
n=49 Participants
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
|
Placebo Colchicine
n=51 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
|
|---|---|---|
|
Transient Ischemic Attack (TIA)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post-operative Day 1 until Postoperative Day 30Outcome measures
| Measure |
Active Colchicine
n=49 Participants
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
|
Placebo Colchicine
n=51 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
|
|---|---|---|
|
Post-operative Infection
|
6 Participants
|
8 Participants
|
Adverse Events
Active Colchicine
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Colchicine
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Colchicine
n=49 participants at risk
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
|
Placebo Colchicine
n=51 participants at risk
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
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
6.1%
3/49 • Number of events 3
|
3.9%
2/51 • Number of events 2
|
|
Nervous system disorders
fall
|
4.1%
2/49 • Number of events 2
|
0.00%
0/51
|
|
Cardiac disorders
unconsciousness
|
0.00%
0/49
|
2.0%
1/51 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Philip Devereaux
Population Health Research Institute
Phone: 905-527-4322
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place