Actively Recruiting
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
39
Research Sites
N/A
Total Duration
On this page
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 60 months
Participants take assigned study medication, which may include aspirin, colchicine, or placebos, to prevent cardiovascular events.
Trial Site Locations
Total: 39 locations
1
Curtin University
Bentley, Western Australia, Australia, 6102
Actively Recruiting
2
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
3
Montreal Heart Institute
Montreal, Quebec, Canada
Actively Recruiting
4
Center for Translational Cardiology and Pragmatic Randomized Trial
Hellerup, Denmark, 2900
Actively Recruiting
5
Heart and Lung Center, Helsinki University Hospital and Helsinki University
Helsinki, Finland, 00029
Actively Recruiting
6
Maison de Santé du Sud Ruthénois
Luc-la-Primaube, Aveyron, France, 12450
Actively Recruiting
7
MSP Ty santé Vannes Tohannic
Vannes, Brittany Region, France, 56000
Actively Recruiting
8
Maison de Santé Pluriprofessionnelle OLEA
Bezouce, Gard, France, 30320
Actively Recruiting
9
MSPU la Source
Vergèze, Gard, France, 30310
Actively Recruiting
10
MSPU Pins Justaret
Pins-Justaret, Haute-Garonne, France, 31860
Actively Recruiting
11
Pôle de Santé et Prevention du Clion
Pornic, Loire Atlantiue, France, 44210
Actively Recruiting
12
CHU de Poitiers
Poitiers, New Aquitaine, France, 86021
Actively Recruiting
13
Centre Medical Villa Ravas
Montpellier, Occitanie, France, 34080
Actively Recruiting
14
CHU de Montpellier
Montpellier, Occitanie, France, 34090
Actively Recruiting
15
CHU de Toulouse
Toulouse, Occitanie, France, 31059
Actively Recruiting
16
Centre de santé Kersanté Toulouse La Terrasse
Toulouse, Occitanie, France, 31500
Actively Recruiting
17
Maison de Santé Pluriprofessionnelle Universitaire LA PROVIDENCE
Toulouse, Occitanie, France, 31500
Actively Recruiting
18
CHU de Nîmes
Nîmes, Occtanie, France, 30029
Actively Recruiting
19
CHU de Nantes
Nantes, Pays de la Loire Region, France, 44093
Actively Recruiting
20
MSP Noirmoitier
Noirmoutier-en-l'Île, Pays de la Loire Region, France, 85330
Actively Recruiting
21
CMS Salvador Allende
La Courneuve, Seine-Saint-Denis, France, 93120
Actively Recruiting
22
MSPU la collégiale
Poissy, Yvelines, France, 78300
Actively Recruiting
23
Cabinet médical Les Oiseaux
Morsang-sur-Orge, France, 91930
Actively Recruiting
24
Centre de santé Kersanté Rosa Parks
Paris, France, 75019
Actively Recruiting
25
Evgenidion Clinic "Agia Trias" S.A.
Athens, Greece, 11528
Actively Recruiting
26
Policlinico Riuniti U.O. Di Diabetologia
Foggia, Apulia, Italy, 71100
Actively Recruiting
27
Ospedale Miulli U.O.C. Endocrinologia
Acquaviva delle Fonti, Bari, Italy, 70021
Actively Recruiting
28
Dipartimento Cure Primarie Diabetologia Territoriale
Ferrara, Emilia-Romagna, Italy, 44100
Actively Recruiting
29
Ospedale Civile Santa Maria Delle Croci U.O. Diabetologia
Ravenna, Emilia-Romagna, Italy, 48100
Actively Recruiting
30
Adiabetologiasst Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy, 20162
Actively Recruiting
31
"Ospedale Oftalmico S.C. Endocrinologia E Metaboliche"
Turin, Piedmont, Italy, "10122
Actively Recruiting
32
Ospedali Riuniti Clinica Di Cardiologia E Aritmologia
Ancona, The Marches, Italy, 60122
Actively Recruiting
33
Ospedale San Giovanni Di Dio, U.O. Diabetologia E Malatt. Metaboliche
Florence, Tuscany, Italy, 50124
Actively Recruiting
34
Ftgm - Stabilimento Di Pisa Uos Vd Attivita Ambulatoriali E Ospedale Diurno
Pisa, Tuscany, Italy, 56124
Actively Recruiting
35
Ospedale San Jacopo Sezione Di Diabetologia
Pistoia, Tuscany, Italy, 51100
Actively Recruiting
36
Ospedale A. Cardarelli Sc Diabetologia Ed Endocrinologia
Campobasso, Italy, 86100
Actively Recruiting
37
Unidade de Saúde Local Amadora-Sintra
Amadora, Portugal, 2700-000
Actively Recruiting
38
Hospital de Luz Lisboa
Lisbon, Portugal, 1500-650
Actively Recruiting
39
Unidade Local de Saue Santa Maria, EPE
Lisbon, Portugal, 1649-035
Actively Recruiting
Research Team
J
Jean-Claude Tardif, MD, FRCPC, FACC, FCAHS
M
Mylène Provencher, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here