Trial Outcomes & Findings for Colchicine Cardiovascular Outcomes Trial (COLCOT) (NCT NCT02551094)
NCT ID: NCT02551094
Last Updated: 2020-10-19
Results Overview
The descriptive statistics are the number of participants having at least one of the composites of the primary endpoint.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4745 participants
Primary outcome timeframe
From randomization to occurence of first event, assessed up to 3.5 years
Results posted on
2020-10-19
Participant Flow
Participant milestones
| Measure |
Colchicine
0.5 mg tablet of colchicine taken once a day
colchicine: 0.5 mg tablet taken once a day
|
Colchicine Placebo
0.5 mg tablet of placebo taken once a day
colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet
|
|---|---|---|
|
Overall Study
STARTED
|
2366
|
2379
|
|
Overall Study
COMPLETED
|
2226
|
2232
|
|
Overall Study
NOT COMPLETED
|
140
|
147
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Colchicine Cardiovascular Outcomes Trial (COLCOT)
Baseline characteristics by cohort
| Measure |
Colchicine
n=2366 Participants
0.5 mg tablet of colchicine taken once a day
colchicine: 0.5 mg tablet taken once a day
|
Colchicine Placebo
n=2379 Participants
0.5 mg tablet of placebo taken once a day
colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet
|
Total
n=4745 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
60.6 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
472 Participants
n=5 Participants
|
437 Participants
n=7 Participants
|
909 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1894 Participants
n=5 Participants
|
1942 Participants
n=7 Participants
|
3836 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic Origin · Asian
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic Origin · Asian and Caucasian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic Origin · Black or African American
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic Origin · Black or African American and Caucasian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic Origin · Black or African American and Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic Origin · Caucasion
|
1350 Participants
n=5 Participants
|
1329 Participants
n=7 Participants
|
2679 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic Origin · Caucasian and Hispanic or Latino
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic Origin · Hispanic or Latino
|
377 Participants
n=5 Participants
|
381 Participants
n=7 Participants
|
758 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic Origin · Indian ancestry
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic Origin · Metis, aboriginal
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic Origin · Native American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic Origin · North African / Middle Eastern
|
70 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic Origin · France n=1051 (Ethnic origin was not provided
|
516 Participants
n=5 Participants
|
535 Participants
n=7 Participants
|
1051 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
230 Participants
n=5 Participants
|
226 Participants
n=7 Participants
|
456 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
739 Participants
n=5 Participants
|
744 Participants
n=7 Participants
|
1483 Participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
111 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
|
Region of Enrollment
Colombia
|
82 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
516 Participants
n=5 Participants
|
535 Participants
n=7 Participants
|
1051 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
270 Participants
n=5 Participants
|
260 Participants
n=7 Participants
|
530 Participants
n=5 Participants
|
|
Region of Enrollment
Lebanon
|
92 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
111 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Region of Enrollment
Tunisia
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
77 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to occurence of first event, assessed up to 3.5 yearsThe descriptive statistics are the number of participants having at least one of the composites of the primary endpoint.
Outcome measures
| Measure |
Colchicine Placebo
n=2379 Participants
0.5 mg tablet of placebo taken once a day
colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet
|
Colchicine
n=2366 Participants
0.5 mg tablet of colchicine taken once a day
colchicine: 0.5 mg tablet taken once a day
|
|---|---|---|
|
First Event of Cardiovascular Death, Resuscitated Cardiac Arrest, Acute Myocardial Infarction, Stroke, or Urgent Hospitalization for Angina Requiring Coronary Revascularization
|
170 Participants
|
131 Participants
|
SECONDARY outcome
Timeframe: From randomization to death, assessed up to 3.5 yearsThe descriptive statistics are the number of participants having deceased.
Outcome measures
| Measure |
Colchicine Placebo
n=2379 Participants
0.5 mg tablet of placebo taken once a day
colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet
|
Colchicine
n=2366 Participants
0.5 mg tablet of colchicine taken once a day
colchicine: 0.5 mg tablet taken once a day
|
|---|---|---|
|
Death (Total Mortality)
|
44 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: From randomization to death, assessed up to 3.5 yearsThe descriptive statistics are presented as the number of participants having had a cardiovascular death.
Outcome measures
| Measure |
Colchicine Placebo
n=2379 Participants
0.5 mg tablet of placebo taken once a day
colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet
|
Colchicine
n=2366 Participants
0.5 mg tablet of colchicine taken once a day
colchicine: 0.5 mg tablet taken once a day
|
|---|---|---|
|
Cardiovascular Death
|
24 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: From randomization to event, assessed up to 3.5 yearsThe descriptive statistics are presented as the number of participants having had resuscitated cardiac arrest
Outcome measures
| Measure |
Colchicine Placebo
n=2379 Participants
0.5 mg tablet of placebo taken once a day
colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet
|
Colchicine
n=2366 Participants
0.5 mg tablet of colchicine taken once a day
colchicine: 0.5 mg tablet taken once a day
|
|---|---|---|
|
Resuscitated Cardiac Arrest
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From randomization to event, assessed up to 3.5 yearsThe descriptive statistics are presented as the number of participants having had myocardial infarction.
Outcome measures
| Measure |
Colchicine Placebo
n=2379 Participants
0.5 mg tablet of placebo taken once a day
colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet
|
Colchicine
n=2366 Participants
0.5 mg tablet of colchicine taken once a day
colchicine: 0.5 mg tablet taken once a day
|
|---|---|---|
|
Myocardial Infarction
|
98 Participants
|
89 Participants
|
SECONDARY outcome
Timeframe: From randomization to event, assessed up to 3.5 yearsThe descriptive statistics are presented as the number of participants having had a stroke.
Outcome measures
| Measure |
Colchicine Placebo
n=2379 Participants
0.5 mg tablet of placebo taken once a day
colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet
|
Colchicine
n=2366 Participants
0.5 mg tablet of colchicine taken once a day
colchicine: 0.5 mg tablet taken once a day
|
|---|---|---|
|
Stroke
|
19 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From randomization to event, assessed up to 3.5 yearsThe descriptive statistics are presented as the number of participants having had urgent hospitalization for angina requiring coronary revascularization.
Outcome measures
| Measure |
Colchicine Placebo
n=2379 Participants
0.5 mg tablet of placebo taken once a day
colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet
|
Colchicine
n=2366 Participants
0.5 mg tablet of colchicine taken once a day
colchicine: 0.5 mg tablet taken once a day
|
|---|---|---|
|
Urgent Hospitalization for Angina Requiring Coronary Revascularization
|
50 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: From randomization to occurence of first event, assessed up to 3.5 yearsThe descriptive statistics are presented as the number of participants having had a first event of cardiovascular death, resuscitated cardiac arrest, acute MI or stroke.
Outcome measures
| Measure |
Colchicine Placebo
n=2379 Participants
0.5 mg tablet of placebo taken once a day
colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet
|
Colchicine
n=2366 Participants
0.5 mg tablet of colchicine taken once a day
colchicine: 0.5 mg tablet taken once a day
|
|---|---|---|
|
First Event of Cardiovascular Death, Resuscitated Cardiac Arrest, Acute MI or Stroke.
|
130 Participants
|
111 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to occurence of first event, assessed up to 3.5 yearsThe descriptive statistics are presented as the number of participants having had a first event of deep venous thrombosis or pulmonary embolus.
Outcome measures
| Measure |
Colchicine Placebo
n=2379 Participants
0.5 mg tablet of placebo taken once a day
colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet
|
Colchicine
n=2366 Participants
0.5 mg tablet of colchicine taken once a day
colchicine: 0.5 mg tablet taken once a day
|
|---|---|---|
|
First Event of Deep Venous Thrombosis or Pulmonary Embolus
|
7 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to event, assessed up to 3.5 yearsThe descriptive statistics are presented as the number of participants having had atrial fibrillation.
Outcome measures
| Measure |
Colchicine Placebo
n=2379 Participants
0.5 mg tablet of placebo taken once a day
colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet
|
Colchicine
n=2366 Participants
0.5 mg tablet of colchicine taken once a day
colchicine: 0.5 mg tablet taken once a day
|
|---|---|---|
|
Atrial Fibrillation
|
40 Participants
|
36 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to event, assessed up to 3.5 yearsThe descriptive statistics are presented as the number of participants having had heart failure hospitalization.
Outcome measures
| Measure |
Colchicine Placebo
n=2379 Participants
0.5 mg tablet of placebo taken once a day
colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet
|
Colchicine
n=2366 Participants
0.5 mg tablet of colchicine taken once a day
colchicine: 0.5 mg tablet taken once a day
|
|---|---|---|
|
Heart Failure Hospitalization
|
18 Participants
|
25 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to event, assessed up to 3.5 yearsThe descriptive statistics are presented as the number of participants having had coronary revascularization.
Outcome measures
| Measure |
Colchicine Placebo
n=2379 Participants
0.5 mg tablet of placebo taken once a day
colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet
|
Colchicine
n=2366 Participants
0.5 mg tablet of colchicine taken once a day
colchicine: 0.5 mg tablet taken once a day
|
|---|---|---|
|
Coronary Revascularization
|
164 Participants
|
132 Participants
|
Adverse Events
Colchicine Placebo
Serious events: 404 serious events
Other events: 371 other events
Deaths: 44 deaths
Colchicine
Serious events: 383 serious events
Other events: 372 other events
Deaths: 41 deaths
Serious adverse events
| Measure |
Colchicine Placebo
n=2346 participants at risk
0.5 mg tablet of placebo taken once a day
colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet
|
Colchicine
n=2330 participants at risk
0.5 mg tablet of colchicine taken once a day
colchicine: 0.5 mg tablet taken once a day
|
|---|---|---|
|
Gastrointestinal disorders
Gastro-intestinal SAE
|
1.5%
36/2346 • Number of events 404 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
2.0%
46/2330 • Number of events 383 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
|
Infections and infestations
Infection SAE
|
1.6%
38/2346 • Number of events 404 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
2.2%
51/2330 • Number of events 383 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia SAE
|
0.38%
9/2346 • Number of events 404 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
0.90%
21/2330 • Number of events 383 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
|
Infections and infestations
Septic Shock SAE
|
0.09%
2/2346 • Number of events 404 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
0.09%
2/2330 • Number of events 383 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
|
General disorders
Other
|
13.6%
319/2346 • Number of events 404 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
11.3%
263/2330 • Number of events 383 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
|
Cardiac disorders
HF hospitalization SAE
|
0.72%
17/2346 • Number of events 371 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
1.1%
25/2330 • Number of events 383 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
Other adverse events
| Measure |
Colchicine Placebo
n=2346 participants at risk
0.5 mg tablet of placebo taken once a day
colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet
|
Colchicine
n=2330 participants at risk
0.5 mg tablet of colchicine taken once a day
colchicine: 0.5 mg tablet taken once a day
|
|---|---|---|
|
Metabolism and nutrition disorders
Diarrhea AE
|
8.9%
208/2346 • Number of events 371 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
9.7%
225/2330 • Number of events 372 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
|
Gastrointestinal disorders
Nauseau AE
|
1.0%
24/2346 • Number of events 371 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
1.8%
43/2330 • Number of events 372 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
|
Gastrointestinal disorders
Flatulence AE
|
0.21%
5/2346 • Number of events 371 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
0.64%
15/2330 • Number of events 372 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
|
Gastrointestinal disorders
GI Haemorrhage AE
|
0.21%
5/2346 • Number of events 371 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
0.30%
7/2330 • Number of events 372 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
|
Blood and lymphatic system disorders
Anaemia AE
|
0.43%
10/2346 • Number of events 371 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
0.60%
14/2330 • Number of events 372 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
|
Blood and lymphatic system disorders
Leukopenia AE
|
0.13%
3/2346 • Number of events 371 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
0.09%
2/2330 • Number of events 372 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
|
Blood and lymphatic system disorders
Thrombocytopenia AE
|
0.30%
7/2346 • Number of events 371 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
0.13%
3/2330 • Number of events 372 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
|
General disorders
Other
|
4.6%
109/2346 • Number of events 371 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
2.7%
63/2330 • Number of events 372 • The time period covered was from randomization to last follow up which lasted 3.5 years.
|
Additional Information
Dr. Jean-Claude Tardif (Principle Investigator)
Montreal Heart Institute
Phone: 514-376-3330
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60