COLchicine and Non-enteric Coated Aspirin in the Cardiovascular Outcomes Trial of Patients With Type 2 Diabetes
COLCOT-T2D
1 other identifier
interventional
10,000
8 countries
39
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2022
Longer than P75 for phase_3
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2022
CompletedFirst Posted
Study publicly available on registry
December 1, 2022
CompletedStudy Start
First participant enrolled
December 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 10, 2026
June 1, 2025
4.9 years
November 11, 2022
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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 Outcomes (9)
Cardiovascular Death
From randomization to cardiovascular death, assessed up to 60 months.
First Event of Resuscitated Cardiac Arrest
From randomization to event, assessed up to 60 months.
First Event of Non-fatal Myocardial Infarction
From randomization to event, assessed up to 60 months.
First Event of Non-fatal Stroke
From randomization to event, assessed up to 60 months
First Occurrence of Urgent Hospitalization for Angina Requiring Coronary Revascularization
From randomization to occurrence, assessed up to 60 months.
- +4 more secondary outcomes
Study Arms (4)
Anti-thrombotic arm
ACTIVE COMPARATORFor patients eligible for aspirin therapy arm.
Anti-thrombotic arm (Placebo)
PLACEBO COMPARATORFor patients eligible for aspirin therapy arm.
Anti-inflammatory arm
ACTIVE COMPARATORFor patients ineligible for aspirin therapy arm.
Anti-inflammatory arm (Placebo)
PLACEBO COMPARATORFor patients ineligible for aspirin therapy arm.
Interventions
0.5 mg tablet taken once daily
tablet taken once daily.
40 mg non-enteric-coated tablet taken twice daily.
non-enteric-coated tablet taken twice daily.
Eligibility Criteria
You may qualify if:
- Men and women aged 55 to 80 years
- Type 2 diabetes treated as per national guidelines
- No previous history of coronary artery disease-related clinical event
- And at least one of the following:
- Duration of diabetes of 5 years or more,
- HbA1c ≥ 8.0% or more in the last 2 years
- Active cigarette smoking,
- High hs-CRP (\> 2.0 mg/L),
- High coronary calcium score (Agatston score \>100),
- High TG-levels (≥1.7 mmol/L) despite lipid lowering therapy administered as per guidelines,
- 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
- High Apo-B (≥1.05 g/L)
- Reduced HDL-C (\<1.05 mmol/L in men, \<1.3 mmol/L in women),
- Lp(a) \>50 mg/dL,
- Peripheral artery disease with stenosis ≥50% or prior revascularization,
- +8 more criteria
You may not qualify if:
- Any prior history of myocardial infarction, angina, coronary revascularization, coronary stenosis \>30%, stroke, transient ischemic attack, or known heart failure
- Known chronic renal insufficiency defined as an estimated glomerular filtration rate (eGFR), using the MDRD equation, of \< 35 mL/min/1.73m2
- 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
- Inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea
- 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
- Any of the following known parameters as measured within the past 90 days, and determined to be non-transient through repeat testing:
- hemoglobin \< 100 g/L
- \. white blood cell count \< 3.0 X 10⁹/L
- platelet count \<110 X 10⁹/L
- ALT \> 3 times the upper limit of normal (ULN)
- total bilirubin \> 2 times ULN (unless due to Gilbert syndrome, which is allowed)
- History of cirrhosis, chronic active hepatitis or severe hepatic disease
- 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
- History of clinically significant drug or alcohol abuse in the last year
- 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)
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Curtin University
Bentley, Western Australia, 6102, Australia
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Center for Translational Cardiology and Pragmatic Randomized Trial
Hellerup, 2900, Denmark
Heart and Lung Center, Helsinki University Hospital and Helsinki University
Helsinki, 00029, Finland
Maison de Santé du Sud Ruthénois
Luc-la-Primaube, Aveyron, 12450, France
MSP Ty santé Vannes Tohannic
Vannes, Brittany Region, 56000, France
Maison de Santé Pluriprofessionnelle OLEA
Bezouce, Gard, 30320, France
MSPU la Source
Vergèze, Gard, 30310, France
MSPU Pins Justaret
Pins-Justaret, Haute-Garonne, 31860, France
Pôle de Santé et Prevention du Clion
Pornic, Loire Atlantiue, 44210, France
CHU de Poitiers
Poitiers, Nouvelle-Aquitaine, 86021, France
Centre Medical Villa Ravas
Montpellier, Occitanie, 34080, France
CHU de Montpellier
Montpellier, Occitanie, 34090, France
CHU de Toulouse
Toulouse, Occitanie, 31059, France
Centre de santé Kersanté Toulouse La Terrasse
Toulouse, Occitanie, 31500, France
Maison de Santé Pluriprofessionnelle Universitaire LA PROVIDENCE
Toulouse, Occitanie, 31500, France
CHU de Nîmes
Nîmes, Occtanie, 30029, France
CHU de Nantes
Nantes, Pays de la Loire Region, 44093, France
MSP Noirmoitier
Noirmoutier-en-l'Île, Pays de la Loire Region, 85330, France
CMS Salvador Allende
La Courneuve, Seine-Saint-Denis, 93120, France
MSPU la collégiale
Poissy, Yvelines, 78300, France
Cabinet médical Les Oiseaux
Morsang-sur-Orge, 91930, France
Centre de santé Kersanté Rosa Parks
Paris, 75019, France
Evgenidion Clinic "Agia Trias" S.A.
Athens, 11528, Greece
Policlinico Riuniti U.O. Di Diabetologia
Foggia, Apulia, 71100, Italy
Ospedale Miulli U.O.C. Endocrinologia
Acquaviva delle Fonti, Bari, 70021, Italy
Dipartimento Cure Primarie Diabetologia Territoriale
Ferrara, Emilia-Romagna, 44100, Italy
Ospedale Civile Santa Maria Delle Croci U.O. Diabetologia
Ravenna, Emilia-Romagna, 48100, Italy
Adiabetologiasst Ospedale Metropolitano Niguarda
Milan, Lombardy, 20162, Italy
"Ospedale Oftalmico S.C. Endocrinologia E Metaboliche"
Turin, Piedmont, "10122, Italy
Ospedali Riuniti Clinica Di Cardiologia E Aritmologia
Ancona, The Marches, 60122, Italy
Ospedale San Giovanni Di Dio, U.O. Diabetologia E Malatt. Metaboliche
Florence, Tuscany, 50124, Italy
Ftgm - Stabilimento Di Pisa Uos Vd Attivita Ambulatoriali E Ospedale Diurno
Pisa, Tuscany, 56124, Italy
Ospedale San Jacopo Sezione Di Diabetologia
Pistoia, Tuscany, 51100, Italy
Ospedale A. Cardarelli Sc Diabetologia Ed Endocrinologia
Campobasso, 86100, Italy
Unidade de Saúde Local Amadora-Sintra
Amadora, 2700-000, Portugal
Hospital de Luz Lisboa
Lisbon, 1500-650, Portugal
Unidade Local de Saue Santa Maria, EPE
Lisbon, 1649-035, Portugal
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2022
First Posted
December 1, 2022
Study Start
December 21, 2022
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
March 10, 2026
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share