What is colchicine studying for type 2 diabetes and heart disease?

Colchicine is being studied to see if it can improve heart-related outcomes in adults with type 2 diabetes who are at high risk for cardiovascular problems. Researchers want to find out if colchicine, alone or with aspirin, helps reduce events like heart attacks and strokes. This trial is sponsored by the Montreal Heart Institute to better understand treatments for these patients.

Who may be eligible for this type 2 diabetes clinical trial?

Adults aged 55 to 80 with type 2 diabetes who have no history of coronary artery disease may be eligible. Both men and women can join if they meet certain risk factors such as a long duration of diabetes, high blood sugar levels, or a history of smoking. Please review eligibility criteria for more details.

Is there any cost to participate in this type 2 diabetes clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to attending visits may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation needs.

Actively Recruiting

Phase 3

Age: 55Years - 80Years

All Genders

ID05633810

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

Led by Montreal Heart Institute · Updated on 2026-03-10

10000

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of colchicine and non-enteric coated aspirin, used alone or together, to improve heart-related outcomes in high-risk adults aged 55 to 80 with type 2 diabetes. This study focuses on preventing major cardiovascular events such as heart attacks, strokes, and urgent hospitalizations in patients who have no prior history of coronary artery disease but possess other risk factors. Participants will be randomly assigned to one of four groups receiving either colchicine, aspirin, both drugs, or placebos. Aspirin is given as a 40 mg non-enteric-coated tablet twice daily, while colchicine is taken as a 0.5 mg tablet once daily. Those who cannot take aspirin will only be assigned to colchicine or its placebo groups. The study lasts up to 60 months, during which cardiovascular events and cognitive function using MoCA scores will be monitored. During the study, participants will undergo regular assessments to track cardiovascular events including heart attacks, stroke, cardiac arrest, atrial fibrillation, heart failure hospitalizations, and coronary procedures. Researchers will also evaluate cognitive function yearly. Safety checks and follow-up visits occur throughout the 5-year period to monitor the participants health and treatment adherence. The primary outcome is the time to the first major cardiovascular event after starting the study medications.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 55Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Men and women aged 55 to 80 years
Diagnosed with type 2 diabetes treated according to national guidelines
No previous coronary artery disease-related clinical event
Must have at least one of the following risk factors: diabetes duration of 5 years or more, HbA1c 8.0% or higher in the last 2 years, active cigarette smoking, high hs-CRP over 2.0 mg/L, high coronary calcium score over 100, elevated triglycerides above 1.7 mmol/L despite lipid therapy, high LDL-C or non-HDL-C despite lipid therapy, high Apo-B, reduced HDL-C, Lp(a) above 50 mg/dL, peripheral artery disease or cerebrovascular disease with significant stenosis or prior revascularization, diabetic retinopathy or neuropathy, mild/moderate proteinuria or micro-albuminuria
Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study
Ability to provide informed consent

You will not qualify if you...

History of heart attack, angina, coronary revascularization, coronary stenosis over 30%, stroke, transient ischemic attack, or heart failure
Chronic kidney disease with estimated glomerular filtration rate below 35 mL/min/1.73m2
Cancer or lymphoproliferative disease within the last 3 years except certain treated skin or prostate cancers
Inflammatory bowel disease or chronic diarrhea
Peptic ulcer or recent gastrointestinal bleeding except mild hemorrhoidal bleeding over 5 years ago
Progressive neuromuscular disease or high creatine phosphokinase levels
Low blood counts or elevated liver enzymes beyond specified limits
Liver diseases such as cirrhosis or severe hepatitis
Pregnant, breastfeeding, or planning pregnancy during the study or 6 months after
Significant drug or alcohol abuse in the past year
Current or planned chronic systemic steroid therapy
Current chronic treatment with aspirin, other antiplatelet agents, or anticoagulants (may still receive colchicine or placebo)
Current colchicine use for other conditions
History of allergy or sensitivity to colchicine or aspirin
Chronic treatment with anti-inflammatory agents like anti-TNF-alpha or NSAIDs
Use of investigational drugs within 30 days before screening
Considered unsuitable by the investigator for any reason

Research Team

Jean-Claude Tardif, MD, FRCPC, FACC, FCAHS

Mylène Provencher, PhD

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