COLchicine and Non-enteric Coated Aspirin in the Cardiovascular Outcomes Trial of Patients With Type 2 Diabetes (COLCOT-T2D)

March 9, 2026 updated by: Montreal Heart Institute

COLchicine and Non-enteric Coated Aspirin in the Cardiovascular Outcomes Trial of Patients With Type 2 Diabetes (COLCOT-T2D)

To evaluate the efficacy and safety of colchicine and non-enteric coated aspirin, combined or alone, to improve cardiovascular outcomes in high-risk patients with type 2 diabetes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men and women aged 55 to 80 years
  2. Type 2 diabetes treated as per national guidelines
  3. No previous history of coronary artery disease-related clinical event

  4. And at least one of the following:

    1. Duration of diabetes of 5 years or more,
    2. HbA1c ≥ 8.0% or more in the last 2 years
    3. Active cigarette smoking,
    4. High hs-CRP (> 2.0 mg/L),
    5. High coronary calcium score (Agatston score >100),
    6. High TG-levels (≥1.7 mmol/L) despite lipid lowering therapy administered as per guidelines,
    7. High LDL-C levels (≥3.5 mmol/L) or high non-HDL-C levels (≥4.2 mmol/L) despite lipid lowering therapy administered as per guidelines
    8. High Apo-B (≥1.05 g/L)
    9. Reduced HDL-C (<1.05 mmol/L in men, <1.3 mmol/L in women),
    10. Lp(a) >50 mg/dL,
    11. Peripheral artery disease with stenosis ≥50% or prior revascularization,
    12. Cerebrovascular disease with stenosis ≥50% or prior revascularization,
    13. Diabetic retinopathy or diabetic neuropathy,
    14. Mild or moderate proteinuria (dipstick analysis) or micro-albuminuria

  5. Women of childbearing potential must have a negative urine pregnancy test at screening/randomization visit 1 and must agree to use an effective method of birth control throughout the study. Acceptable means of birth control include: oral contraceptives, implantable contraceptives, injectable contraceptives, transdermal contraceptives, intrauterine devices, male or female condoms with spermicide, abstinence, or a sterile sexual partner.

    Women are considered not of childbearing potential if they either:

    1. Have had a hysterectomy or tubal ligation prior to baseline visit or
    2. Are postmenopausal defined as no menses for 12 months or a FSH level (if available) in the menopausal range.
  6. Patients with the capacity to provide informed consent.

Exclusion Criteria:

  1. Any prior history of myocardial infarction, angina, coronary revascularization, coronary stenosis >30%, stroke, transient ischemic attack, or known heart failure
  2. Known chronic renal insufficiency defined as an estimated glomerular filtration rate (eGFR), using the MDRD equation, of < 35 mL/min/1.73m2
  3. History of cancer or lymphoproliferative disease within the last 3 years other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix and/or low-grade prostate cancer
  4. Inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea
  5. Peptic ulcer diagnosed within the last 24 months or previous gastro-intestinal bleeding, except for mild hemorrhoidal bleeding more than 5 years ago which is permitted (patients meeting this exclusion criterion will not be randomized to receive aspirin or placebo but can be randomized to receive colchicine or placebo)
  6. Pre-existent progressive neuromuscular disease or known CPK level > 3 times the upper limit of normal as measured within the past 30 days and determined to be non-transient through repeat testing

  7. Any of the following known parameters as measured within the past 90 days, and determined to be non-transient through repeat testing:

    1. hemoglobin < 100 g/L
    2. 2. white blood cell count < 3.0 X 10⁹/L
    3. platelet count <110 X 10⁹/L
    4. ALT > 3 times the upper limit of normal (ULN)
    5. total bilirubin > 2 times ULN (unless due to Gilbert syndrome, which is allowed)
  8. History of cirrhosis, chronic active hepatitis or severe hepatic disease
  9. Female patient who is pregnant, or breast-feeding or is considering becoming pregnant during the study or for 6 months after the last dose of study medication
  10. History of clinically significant drug or alcohol abuse in the last year
  11. Patient is currently using or plans to begin chronic systemic steroid therapy (oral or intravenous) during the study (topical or inhaled steroids are allowed, as well as replacement corticosteroids for adrenal insufficiency)
  12. Current chronic treatment with aspirin or another antiplatelet agent (patients meeting this exclusion criterion will not be randomized to receive aspirin or placebo but can be randomized to receive colchicine or placebo)
  13. Chronic treatment with an anticoagulant agent (patients meeting this exclusion criterion will not be randomized to receive aspirin or placebo but can be randomized to receive colchicine or placebo)
  14. Current use of colchicine for other indications (mainly chronic indications consisting of Familial Mediterranean Fever or gout); there is no wash-out period required for patients who have been treated with colchicine and stopped treatment prior to enrolment
  15. History of an allergic reaction or significant sensitivity to colchicine
  16. History of an allergic reaction or significant sensitivity to aspirin (patients meeting this exclusion criterion will not be randomized to receive aspirin or placebo but can be randomized to receive colchicine or placebo)
  17. Chronic treatment with an anti-inflammatory agent (for example, anti-TNF-alpha or nonsteroidal anti-inflammatory drug (NSAID))
  18. Use of an investigational chemical agent less than 30 days or 5 half-lives prior to the screening visit (whichever is longer)
  19. Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anti-thrombotic arm
For patients eligible for aspirin therapy arm.
Drug: Aspirin
40 mg non-enteric-coated tablet taken twice daily.
Drug: Aspirin Placebo
non-enteric-coated tablet taken twice daily.
Drug: Colchicine
0.5 mg tablet taken once daily
Drug: Colchicine Placebo
tablet taken once daily.
Placebo Comparator: Anti-thrombotic arm (Placebo)
For patients eligible for aspirin therapy arm.
Drug: Aspirin
40 mg non-enteric-coated tablet taken twice daily.
Drug: Aspirin Placebo
non-enteric-coated tablet taken twice daily.
Drug: Colchicine
0.5 mg tablet taken once daily
Drug: Colchicine Placebo
tablet taken once daily.
Active Comparator: Anti-inflammatory arm
For patients ineligible for aspirin therapy arm.
Drug: Colchicine
0.5 mg tablet taken once daily
Drug: Colchicine Placebo
tablet taken once daily.
Placebo Comparator: Anti-inflammatory arm (Placebo)
For patients ineligible for aspirin therapy arm.
Drug: Colchicine
0.5 mg tablet taken once daily
Drug: Colchicine Placebo
tablet taken once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First event of the composite of cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, or urgent hospitalization for angina requiring coronary revascularization.
Time Frame: From randomization to occurrence of first event, assessed up to 60 months.
The number of participants having at least one of the composite of the primary endpoint.
From randomization to occurrence of first event, assessed up to 60 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular Death
Time Frame: From randomization to cardiovascular death, assessed up to 60 months.
The number of participants having a cardiovascular death.
From randomization to cardiovascular death, assessed up to 60 months.
First Event of Resuscitated Cardiac Arrest
Time Frame: From randomization to event, assessed up to 60 months.
The number of participants having at least 1 resuscitated cardiac arrest.
From randomization to event, assessed up to 60 months.
First Event of Non-fatal Myocardial Infarction
Time Frame: From randomization to event, assessed up to 60 months.
The number of participants having at least 1 myocardial infarction.
From randomization to event, assessed up to 60 months.
First Event of Non-fatal Stroke
Time Frame: From randomization to event, assessed up to 60 months
The number of participants having at least 1 stroke.
From randomization to event, assessed up to 60 months
First Occurrence of Urgent Hospitalization for Angina Requiring Coronary Revascularization
Time Frame: From randomization to occurrence, assessed up to 60 months.
The number of participants having at least 1 urgent hospitalization for angina requiring coronary revascularization.
From randomization to occurrence, assessed up to 60 months.
First Event of Atrial Fibrillation
Time Frame: From randomization to event, assessed up to 60 months.
The number of participants having at least 1 atrial fibrillation.
From randomization to event, assessed up to 60 months.
First Occurrence of Heart Failure Hospitalization
Time Frame: From randomization to occurrence, assessed up to 60 months.
The number of participants having at least 1 heart failure hospitalization.
From randomization to occurrence, assessed up to 60 months.
First Occurrence of Coronary Revascularization
Time Frame: From randomization to occurrence, assessed up to 60 months.
The number of participants having at least 1 coronary revascularization.
From randomization to occurrence, assessed up to 60 months.
MoCA Scores Assessed Over Time
Time Frame: From randomization to yearly follow-ups until the end-of-study visit, assessed up to 60 months.
Change from randomization in MoCA score at yearly follow-ups (excluding the first-year visit) until the end-of-study visit.
From randomization to yearly follow-ups until the end-of-study visit, assessed up to 60 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montreal Heart Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 11, 2022

First Submitted That Met QC Criteria

November 30, 2022

First Posted (Actual)

December 1, 2022

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHICC-2021-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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