Trial · NCT02551094

Colchicine Cardiovascular Outcomes Trial (COLCOT)

NCT02551094, Phase 3, Completed, Montreal Heart Institute; results first posted 2020-10-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Colchicine Cardiovascular Outcomes Trial (COLCOT). Trials, record NCT02551094. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02551094

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Colchicine Cardiovascular Outcomes Trial (COLCOT)
NCT number: NCT02551094
Status: Completed
Phases: Phase 3
Enrollment: 4,745 participants, actual
Lead sponsor: Montreal Heart Institute
Conditions: Coronary Artery Disease, Myocardial Infarction
Interventions: colchicine, colchicine placebo
First posted: 2015-09-16
Last updated: 2020-10-19
Results first posted: 2020-10-19

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	First Event of Cardiovascular Death, Resuscitated Cardiac Arrest, Acute Myocardial Infarction, Stroke, or Urgent Hospitalization for Angina Requiring Coronary Revascularization	From randomization to occurence of first event, assessed up to 3.5 years	The descriptive statistics are the number of participants having at least one of the composites of the primary endpoint.
Secondary	Death (Total Mortality)	From randomization to death, assessed up to 3.5 years	The descriptive statistics are the number of participants having deceased.
Secondary	Cardiovascular Death	From randomization to death, assessed up to 3.5 years	The descriptive statistics are presented as the number of participants having had a cardiovascular death.
Secondary	Resuscitated Cardiac Arrest	From randomization to event, assessed up to 3.5 years	The descriptive statistics are presented as the number of participants having had resuscitated cardiac arrest
Secondary	Myocardial Infarction	From randomization to event, assessed up to 3.5 years	The descriptive statistics are presented as the number of participants having had myocardial infarction.
Secondary	Stroke	From randomization to event, assessed up to 3.5 years	The descriptive statistics are presented as the number of participants having had a stroke.
Secondary	Urgent Hospitalization for Angina Requiring Coronary Revascularization	From randomization to event, assessed up to 3.5 years	The descriptive statistics are presented as the number of participants having had urgent hospitalization for angina requiring coronary revascularization.
Secondary	First Event of Cardiovascular Death, Resuscitated Cardiac Arrest, Acute MI or Stroke.	From randomization to occurence of first event, assessed up to 3.5 years	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.
Other	First Event of Deep Venous Thrombosis or Pulmonary Embolus	From randomization to occurence of first event, assessed up to 3.5 years	The descriptive statistics are presented as the number of participants having had a first event of deep venous thrombosis or pulmonary embolus.
Other	Atrial Fibrillation	From randomization to event, assessed up to 3.5 years	The descriptive statistics are presented as the number of participants having had atrial fibrillation.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	First Event of Cardiovascular Death, Resuscitated Cardiac Arrest, Acute Myocardial Infarction, Stroke, or Urgent Hospitalization for Angina Requiring Coronary Revascularization	From randomization to occurence of first event, assessed up to 3.5 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Death (Total Mortality)	From randomization to death, assessed up to 3.5 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Cardiovascular Death	From randomization to death, assessed up to 3.5 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Resuscitated Cardiac Arrest	From randomization to event, assessed up to 3.5 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Myocardial Infarction	From randomization to event, assessed up to 3.5 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Stroke	From randomization to event, assessed up to 3.5 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Urgent Hospitalization for Angina Requiring Coronary Revascularization	From randomization to event, assessed up to 3.5 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	First Event of Cardiovascular Death, Resuscitated Cardiac Arrest, Acute MI or Stroke.	From randomization to occurence of first event, assessed up to 3.5 years	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	First Event of Deep Venous Thrombosis or Pulmonary Embolus	From randomization to occurence of first event, assessed up to 3.5 years	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Atrial Fibrillation	From randomization to event, assessed up to 3.5 years	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
First Event of Cardiovascular Death, Resuscitated Cardiac Arrest, Acute Myocardial Infarction, Stroke, or Urgent Hospitalization for Angina Requiring Coronary Revascularization	Colchicine Placebo	170	Participants
First Event of Cardiovascular Death, Resuscitated Cardiac Arrest, Acute Myocardial Infarction, Stroke, or Urgent Hospitalization for Angina Requiring Coronary Revascularization	Colchicine	131	Participants
Death (Total Mortality)	Colchicine Placebo	44	Participants
Death (Total Mortality)	Colchicine	43	Participants
Cardiovascular Death	Colchicine Placebo	24	Participants
Cardiovascular Death	Colchicine	20	Participants
Resuscitated Cardiac Arrest	Colchicine Placebo	6	Participants
Resuscitated Cardiac Arrest	Colchicine	5	Participants
Myocardial Infarction	Colchicine Placebo	98	Participants
Myocardial Infarction	Colchicine	89	Participants

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Colchicine	2,366
Overall Study	STARTED	Colchicine Placebo	2,379
Overall Study	COMPLETED	Colchicine	2,226
Overall Study	COMPLETED	Colchicine Placebo	2,232
Overall Study	NOT COMPLETED	Colchicine	140
Overall Study	NOT COMPLETED	Colchicine Placebo	147

Source ClinicalTrials.gov

Adverse events28

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhea AE	Metabolism and nutrition disorders	Colchicine Placebo	208	2,346	371
other	Diarrhea AE	Metabolism and nutrition disorders	Colchicine	225	2,330	372
other	Nauseau AE	Gastrointestinal disorders	Colchicine Placebo	24	2,346	371
other	Nauseau AE	Gastrointestinal disorders	Colchicine	43	2,330	372
other	Flatulence AE	Gastrointestinal disorders	Colchicine Placebo	5	2,346	371
other	Flatulence AE	Gastrointestinal disorders	Colchicine	15	2,330	372
other	GI Haemorrhage AE	Gastrointestinal disorders	Colchicine Placebo	5	2,346	371
other	GI Haemorrhage AE	Gastrointestinal disorders	Colchicine	7	2,330	372
other	Anaemia AE	Blood and lymphatic system disorders	Colchicine Placebo	10	2,346	371
other	Anaemia AE	Blood and lymphatic system disorders	Colchicine	14	2,330	372

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Colchicine Placebo	44	2,346
Total, all-cause mortality	Colchicine	41	2,330
Total, other adverse events	Colchicine Placebo	371	2,346
Total, other adverse events	Colchicine	372	2,330
Total, serious adverse events	Colchicine Placebo	404	2,346
Total, serious adverse events	Colchicine	383	2,330

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31733140	DERIVED	PubMed
32860034	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons14

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Colchicine vs Colchicine Placebo: Heart Failure Hospitalization	Trial comparisons
Colchicine vs Colchicine Placebo: Coronary Revascularization	Trial comparisons
Colchicine vs Colchicine Placebo: First Event of Cardiovascular Death, Resuscitated Cardiac Arrest, Acute Myocardial Infarction, Stroke, or Urgent Hospitalization for Angina Requiring Coronary Revascularization	Trial comparisons
Colchicine vs Colchicine Placebo: Cardiovascular Death	Trial comparisons
Colchicine vs Colchicine Placebo: Death (Total Mortality)	Trial comparisons
Colchicine vs Colchicine Placebo: Atrial Fibrillation	Trial comparisons
Colchicine vs Colchicine Placebo: Stroke	Trial comparisons
Colchicine vs Colchicine Placebo: Resuscitated Cardiac Arrest	Trial comparisons
Colchicine vs Colchicine Placebo: Myocardial Infarction	Trial comparisons
Colchicine vs Colchicine Placebo: deaths from any cause	Trial comparisons

1 to 10 of 14

See all 14 trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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