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Colchicine Cardiovascular Outcomes Trial (COLCOT) (COLCOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02551094
Recruitment Status : Completed
First Posted : September 16, 2015
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Montreal Heart Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Coronary Artery Disease
Myocardial Infarction
Interventions Drug: colchicine
Drug: colchicine placebo
Enrollment 4745
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Colchicine Colchicine Placebo
Hide Arm/Group Description

0.5 mg tablet of colchicine taken once a day

colchicine: 0.5 mg tablet taken once a day

0.5 mg tablet of placebo taken once a day

colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet

Period Title: Overall Study
Started 2366 2379
Completed 2226 2232
Not Completed 140 147
Arm/Group Title Colchicine Colchicine Placebo Total
Hide Arm/Group Description

0.5 mg tablet of colchicine taken once a day

colchicine: 0.5 mg tablet taken once a day

0.5 mg tablet of placebo taken once a day

colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet

Total of all reporting groups
Overall Number of Baseline Participants 2366 2379 4745
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2366 participants 2379 participants 4745 participants
60.6  (10.7) 60.5  (10.6) 60.6  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2366 participants 2379 participants 4745 participants
Female
472
  19.9%
437
  18.4%
909
  19.2%
Male
1894
  80.1%
1942
  81.6%
3836
  80.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnic Origin Number Analyzed 2366 participants 2379 participants 4745 participants
Asian
26
   1.1%
27
   1.1%
53
   1.1%
Asian and Caucasian
1
   0.0%
1
   0.0%
2
   0.0%
Black or African American
3
   0.1%
8
   0.3%
11
   0.2%
Black or African American and Caucasian
1
   0.0%
0
   0.0%
1
   0.0%
Black or African American and Hispanic or Latino
1
   0.0%
1
   0.0%
2
   0.0%
Caucasion
1350
  57.1%
1329
  55.9%
2679
  56.5%
Caucasian and Hispanic or Latino
17
   0.7%
18
   0.8%
35
   0.7%
Hispanic or Latino
377
  15.9%
381
  16.0%
758
  16.0%
Indian ancestry
1
   0.0%
0
   0.0%
1
   0.0%
Metis, aboriginal
0
   0.0%
1
   0.0%
1
   0.0%
Native American
3
   0.1%
5
   0.2%
8
   0.2%
North African / Middle Eastern
70
   3.0%
73
   3.1%
143
   3.0%
France n=1051 (Ethnic origin was not provided
516
  21.8%
535
  22.5%
1051
  22.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2366 participants 2379 participants 4745 participants
Argentina
230
   9.7%
226
   9.5%
456
   9.6%
Canada
739
  31.2%
744
  31.3%
1483
  31.3%
Chile
111
   4.7%
108
   4.5%
219
   4.6%
Colombia
82
   3.5%
84
   3.5%
166
   3.5%
France
516
  21.8%
535
  22.5%
1051
  22.1%
Germany
6
   0.3%
2
   0.1%
8
   0.2%
Italy
270
  11.4%
260
  10.9%
530
  11.2%
Lebanon
92
   3.9%
88
   3.7%
180
   3.8%
Portugal
111
   4.7%
116
   4.9%
227
   4.8%
Spain
32
   1.4%
31
   1.3%
63
   1.3%
Tunisia
100
   4.2%
100
   4.2%
200
   4.2%
United Kingdom
77
   3.3%
77
   3.2%
154
   3.2%
1.Primary Outcome
Title First Event of Cardiovascular Death, Resuscitated Cardiac Arrest, Acute Myocardial Infarction, Stroke, or Urgent Hospitalization for Angina Requiring Coronary Revascularization
Hide Description The descriptive statistics are the number of participants having at least one of the composites of the primary endpoint.
Time Frame From randomization to occurence of first event, assessed up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo Colchicine
Hide Arm/Group Description:

0.5 mg tablet of placebo taken once a day

colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet

0.5 mg tablet of colchicine taken once a day

colchicine: 0.5 mg tablet taken once a day

Overall Number of Participants Analyzed 2379 2366
Measure Type: Count of Participants
Unit of Measure: Participants
170
   7.1%
131
   5.5%
2.Secondary Outcome
Title Death (Total Mortality)
Hide Description The descriptive statistics are the number of participants having deceased.
Time Frame From randomization to death, assessed up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo Colchicine
Hide Arm/Group Description:

0.5 mg tablet of placebo taken once a day

colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet

0.5 mg tablet of colchicine taken once a day

colchicine: 0.5 mg tablet taken once a day

Overall Number of Participants Analyzed 2379 2366
Measure Type: Count of Participants
Unit of Measure: Participants
44
   1.8%
43
   1.8%
3.Secondary Outcome
Title Cardiovascular Death
Hide Description The descriptive statistics are presented as the number of participants having had a cardiovascular death.
Time Frame From randomization to death, assessed up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo Colchicine
Hide Arm/Group Description:

0.5 mg tablet of placebo taken once a day

colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet

0.5 mg tablet of colchicine taken once a day

colchicine: 0.5 mg tablet taken once a day

Overall Number of Participants Analyzed 2379 2366
Measure Type: Count of Participants
Unit of Measure: Participants
24
   1.0%
20
   0.8%
4.Secondary Outcome
Title Resuscitated Cardiac Arrest
Hide Description The descriptive statistics are presented as the number of participants having had resuscitated cardiac arrest
Time Frame From randomization to event, assessed up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo Colchicine
Hide Arm/Group Description:

0.5 mg tablet of placebo taken once a day

colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet

0.5 mg tablet of colchicine taken once a day

colchicine: 0.5 mg tablet taken once a day

Overall Number of Participants Analyzed 2379 2366
Measure Type: Count of Participants
Unit of Measure: Participants
6
   0.3%
5
   0.2%
5.Secondary Outcome
Title Myocardial Infarction
Hide Description The descriptive statistics are presented as the number of participants having had myocardial infarction.
Time Frame From randomization to event, assessed up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo Colchicine
Hide Arm/Group Description:

0.5 mg tablet of placebo taken once a day

colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet

0.5 mg tablet of colchicine taken once a day

colchicine: 0.5 mg tablet taken once a day

Overall Number of Participants Analyzed 2379 2366
Measure Type: Count of Participants
Unit of Measure: Participants
98
   4.1%
89
   3.8%
6.Secondary Outcome
Title Stroke
Hide Description The descriptive statistics are presented as the number of participants having had a stroke.
Time Frame From randomization to event, assessed up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo Colchicine
Hide Arm/Group Description:

0.5 mg tablet of placebo taken once a day

colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet

0.5 mg tablet of colchicine taken once a day

colchicine: 0.5 mg tablet taken once a day

Overall Number of Participants Analyzed 2379 2366
Measure Type: Count of Participants
Unit of Measure: Participants
19
   0.8%
5
   0.2%
7.Secondary Outcome
Title Urgent Hospitalization for Angina Requiring Coronary Revascularization
Hide Description The descriptive statistics are presented as the number of participants having had urgent hospitalization for angina requiring coronary revascularization.
Time Frame From randomization to event, assessed up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo Colchicine
Hide Arm/Group Description:

0.5 mg tablet of placebo taken once a day

colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet

0.5 mg tablet of colchicine taken once a day

colchicine: 0.5 mg tablet taken once a day

Overall Number of Participants Analyzed 2379 2366
Measure Type: Count of Participants
Unit of Measure: Participants
50
   2.1%
25
   1.1%
8.Secondary Outcome
Title First Event of Cardiovascular Death, Resuscitated Cardiac Arrest, Acute MI or Stroke.
Hide Description The descriptive statistics are presented as the number of participants having had a first event of cardiovascular death, resuscitated cardiac arrest, acute MI or stroke.
Time Frame From randomization to occurence of first event, assessed up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo Colchicine
Hide Arm/Group Description:

0.5 mg tablet of placebo taken once a day

colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet

0.5 mg tablet of colchicine taken once a day

colchicine: 0.5 mg tablet taken once a day

Overall Number of Participants Analyzed 2379 2366
Measure Type: Count of Participants
Unit of Measure: Participants
130
   5.5%
111
   4.7%
9.Other Pre-specified Outcome
Title First Event of Deep Venous Thrombosis or Pulmonary Embolus
Hide Description The descriptive statistics are presented as the number of participants having had a first event of deep venous thrombosis or pulmonary embolus.
Time Frame From randomization to occurence of first event, assessed up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo Colchicine
Hide Arm/Group Description:

0.5 mg tablet of placebo taken once a day

colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet

0.5 mg tablet of colchicine taken once a day

colchicine: 0.5 mg tablet taken once a day

Overall Number of Participants Analyzed 2379 2366
Measure Type: Count of Participants
Unit of Measure: Participants
7
   0.3%
10
   0.4%
10.Other Pre-specified Outcome
Title Atrial Fibrillation
Hide Description The descriptive statistics are presented as the number of participants having had atrial fibrillation.
Time Frame From randomization to event, assessed up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo Colchicine
Hide Arm/Group Description:

0.5 mg tablet of placebo taken once a day

colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet

0.5 mg tablet of colchicine taken once a day

colchicine: 0.5 mg tablet taken once a day

Overall Number of Participants Analyzed 2379 2366
Measure Type: Count of Participants
Unit of Measure: Participants
40
   1.7%
36
   1.5%
11.Other Pre-specified Outcome
Title Heart Failure Hospitalization
Hide Description The descriptive statistics are presented as the number of participants having had heart failure hospitalization.
Time Frame From randomization to event, assessed up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo Colchicine
Hide Arm/Group Description:

0.5 mg tablet of placebo taken once a day

colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet

0.5 mg tablet of colchicine taken once a day

colchicine: 0.5 mg tablet taken once a day

Overall Number of Participants Analyzed 2379 2366
Measure Type: Count of Participants
Unit of Measure: Participants
18
   0.8%
25
   1.1%
12.Other Pre-specified Outcome
Title Coronary Revascularization
Hide Description The descriptive statistics are presented as the number of participants having had coronary revascularization.
Time Frame From randomization to event, assessed up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo Colchicine
Hide Arm/Group Description:

0.5 mg tablet of placebo taken once a day

colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet

0.5 mg tablet of colchicine taken once a day

colchicine: 0.5 mg tablet taken once a day

Overall Number of Participants Analyzed 2379 2366
Measure Type: Count of Participants
Unit of Measure: Participants
164
   6.9%
132
   5.6%
Time Frame The time period covered was from randomization to last follow up which lasted 3.5 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Colchicine Placebo Colchicine
Hide Arm/Group Description

0.5 mg tablet of placebo taken once a day

colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet

0.5 mg tablet of colchicine taken once a day

colchicine: 0.5 mg tablet taken once a day

All-Cause Mortality
Colchicine Placebo Colchicine
Affected / at Risk (%) Affected / at Risk (%)
Total   44/2346 (1.88%)      41/2330 (1.76%)    
Hide Serious Adverse Events
Colchicine Placebo Colchicine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   404/2346 (17.22%)      383/2330 (16.44%)    
Cardiac disorders     
HF hospitalization SAE   17/2346 (0.72%)  371 25/2330 (1.07%)  383
Gastrointestinal disorders     
Gastro-intestinal SAE   36/2346 (1.53%)  404 46/2330 (1.97%)  383
General disorders     
Other   319/2346 (13.60%)  404 263/2330 (11.29%)  383
Infections and infestations     
Infection SAE   38/2346 (1.62%)  404 51/2330 (2.19%)  383
Septic Shock SAE   2/2346 (0.09%)  404 2/2330 (0.09%)  383
Respiratory, thoracic and mediastinal disorders     
Pneumonia SAE   9/2346 (0.38%)  404 21/2330 (0.90%)  383
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Colchicine Placebo Colchicine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   371/2346 (15.81%)      372/2330 (15.97%)    
Blood and lymphatic system disorders     
Anaemia AE   10/2346 (0.43%)  371 14/2330 (0.60%)  372
Leukopenia AE   3/2346 (0.13%)  371 2/2330 (0.09%)  372
Thrombocytopenia AE   7/2346 (0.30%)  371 3/2330 (0.13%)  372
Gastrointestinal disorders     
Nauseau AE   24/2346 (1.02%)  371 43/2330 (1.85%)  372
Flatulence AE   5/2346 (0.21%)  371 15/2330 (0.64%)  372
GI Haemorrhage AE   5/2346 (0.21%)  371 7/2330 (0.30%)  372
General disorders     
Other   109/2346 (4.65%)  371 63/2330 (2.70%)  372
Metabolism and nutrition disorders     
Diarrhea AE   208/2346 (8.87%)  371 225/2330 (9.66%)  372
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jean-Claude Tardif (Principle Investigator)
Organization: Montreal Heart Institute
Phone: 514-376-3330 ext 3612
EMail: jean-claude.tardif@icm-mhi.org
Layout table for additonal information
Responsible Party: Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT02551094    
Other Study ID Numbers: MHIPS-003
First Submitted: August 26, 2015
First Posted: September 16, 2015
Results First Submitted: July 17, 2020
Results First Posted: October 19, 2020
Last Update Posted: October 19, 2020