Colchicine Cardiovascular Outcomes Trial (COLCOT) (COLCOT)

• 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: Montreal Heart Institute
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Colchicine	Colchicine Placebo
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

Baseline Characteristics

Arm/Group Title		Colchicine	Colchicine Placebo	Total
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
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%

Outcome Measures

1. Primary Outcome

Title	First Event of Cardiovascular Death, Resuscitated Cardiac Arrest, Acute Myocardial Infarction, Stroke, or Urgent Hospitalization for Angina Requiring Coronary Revascularization
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Colchicine Placebo	Colchicine
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)
Description	The descriptive statistics are the number of participants having deceased.
Time Frame	From randomization to death, assessed up to 3.5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Colchicine Placebo	Colchicine
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Colchicine Placebo	Colchicine
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Colchicine Placebo	Colchicine
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Colchicine Placebo	Colchicine
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Colchicine Placebo	Colchicine
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Colchicine Placebo	Colchicine
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.
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Colchicine Placebo	Colchicine
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Colchicine Placebo	Colchicine
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Colchicine Placebo	Colchicine
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Colchicine Placebo	Colchicine
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Colchicine Placebo	Colchicine
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%

Adverse Events

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
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%)
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
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

Limitations and Caveats

[Not Specified]

More Information

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

• 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bouabdallaoui N, Tardif JC, Waters DD, Pinto FJ, Maggioni AP, Diaz R, Berry C, Koenig W, Lopez-Sendon J, Gamra H, Kiwan GS, Blondeau L, Orfanos A, Ibrahim R, Gregoire JC, Dube MP, Samuel M, Morel O, Lim P, Bertrand OF, Kouz S, Guertin MC, L'Allier PL, Roubille F. Time-to-treatment initiation of colchicine and cardiovascular outcomes after myocardial infarction in the Colchicine Cardiovascular Outcomes Trial (COLCOT). Eur Heart J. 2020 Nov 7;41(42):4092-4099. doi: 10.1093/eurheartj/ehaa659.

Tardif JC, Kouz S, Waters DD, Bertrand OF, Diaz R, Maggioni AP, Pinto FJ, Ibrahim R, Gamra H, Kiwan GS, Berry C, Lopez-Sendon J, Ostadal P, Koenig W, Angoulvant D, Gregoire JC, Lavoie MA, Dube MP, Rhainds D, Provencher M, Blondeau L, Orfanos A, L'Allier PL, Guertin MC, Roubille F. Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction. N Engl J Med. 2019 Dec 26;381(26):2497-2505. doi: 10.1056/NEJMoa1912388. Epub 2019 Nov 16.

• 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