Diabete Type 2Phase 3COLCOT-T2DNCT05633810
COLchicine and Non-enteric Coated Aspirin in the Cardiovascular Outcomes Trial of Patients With Type 2 Diabetes
A Phase 3 study testing Aspirin and Colchicine in people with Diabete Type 2 and Cardiovascular Diseases, run by Montreal Heart Institute at 39 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Diabete Type 2, Cardiovascular Diseases
- What is being tested?
- Aspirin and Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10,000 participants
- Where
- 39 sitesin 8 countries
- Study dates
- 21 Dec 2022to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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,
- Cerebrovascular disease with stenosis ≥50% or prior revascularization,
- Diabetic retinopathy or diabetic neuropathy,
- Mild or moderate proteinuria (dipstick analysis) or micro-albuminuria
- 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:
- Have had a hysterectomy or tubal ligation prior to baseline visit or
- Are postmenopausal defined as no menses for 12 months or a FSH level (if available) in the menopausal range.
- Patients with the capacity to provide informed consent.
Who cannot join
- 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
- 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)
- 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
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- 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
- 2. 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)
- 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)
- 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)
- 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
- History of an allergic reaction or significant sensitivity to colchicine
- 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)
- Chronic treatment with an anti-inflammatory agent (for example, anti-TNF-alpha or nonsteroidal anti-inflammatory drug (NSAID))
- Use of an investigational chemical agent less than 30 days or 5 half-lives prior to the screening visit (whichever is longer)
- Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Trial locations and contacts
39 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Jean-Claude Tardif, MD, FRCPC, FACC, FCAHS contact
39 sites in 8 countries
France19 sites, 19 recruiting
- Recruiting
Maison de Santé Pluriprofessionnelle OLEA
Bezouce, Gard, 30320
Aurélie URENA DORES, MD, 04 13 35 45 15, docteur.urenadores@hotmail.com
Frieda TAMOUTE, 608869613, frieda.tamoute@umontpellier.fr
- Recruiting
CMS Salvador Allende
La Courneuve, Seine-Saint-Denis, 93120
Julien LE BRETON, MD, 01 49 92 60 60, j.le.breton.com@gmail.com ; julien.le-breton@lacourneuve.fr
Sarah EDJEKOUANE, 760622535, s.edjekouane@cnge.fr
- Recruiting
Maison de Santé du Sud Ruthénois
Luc-la-Primaube, Aveyron, 12450
Denis PEREZ, MD, 0565720606, denis.perezpro@hotmail.com
Marie VAYSSETTES, 0672157855, marie.vayssettes@dumg-toulouse.fr
- Recruiting
Centre Medical Villa Ravas
Montpellier, Occitanie, 34080
Karolina GRIFFITHS, karolina.griffiths@umontpellier.fr
Frieda TAMOUTE, 608869613, frieda.tamoute@umontpellier.fr
- Recruiting
CHU de Montpellier
Montpellier, Occitanie, 34090
Francois Roubille, MD, 0467336733, f-roubille@chu-montpellier.fr
Sonia Soltani, s-soltani@chu-montpellier.fr
- Recruiting
Cabinet médical Les Oiseaux
Morsang-sur-Orge, 91930
Alexandre MALMARTEL, MD, 0185121830, alexandre.malmartel@u-paris.fr
Sarah EDJEKOUANE, 0760622535, s.edjekouane@cnge.fr
- Recruiting
CHU de Nantes
Nantes, Pays de la Loire Region, 44093
Bertrand CARIOU, MD, 0253482726, bertrand.cariou@univ-nantes.fr
Audrey ERNOULD, 0253482726, audrey.ernould@chu-nantes.fr
- Recruiting
CHU de Nîmes
Nîmes, Occtanie, 30029
Guillaume Cayla, MD, 0466683116, cayla.guillaume@gmail.com
Chrystel LEPERCHOIS, Chrystel.LEPERCHOIS@chu-nimes.fr
- Recruiting
MSP Noirmoitier
Noirmoutier-en-l'Île, Pays de la Loire Region, 85330
Cyrille VARTANIAN, MD, 0244769054, cyrille.vartanian@univ-nantes.fr
Emilie GUEGAN, 0253526332, emilie.guegan@chu-nantes.fr
- Recruiting
Centre de santé Kersanté Rosa Parks
Paris, 75019
Laurence MARRIE, 0183792816
- Recruiting
MSPU Pins Justaret
Pins-Justaret, Haute-Garonne, 31860
Julie DUPOUY, MD, 0561762700, julie.dupouy@dumg-toulouse.fr
Marie VAYSSETTES, 0672157855, marie.vayssettes@dumg-toulouse.fr
- Recruiting
MSPU la collégiale
Poissy, Yvelines, 78300
Olivier SAINT LARY, MD, 0185470899, o.saintlary@cnge.fr
Sarah EDJEKOUANE, 0760622535, s.edjekouane@cnge.fr
- Recruiting
CHU de Poitiers
Poitiers, New Aquitaine, 86021
Claire Bouleti, MD, 0549444325, claire.bouleti@chu-poitiers.fr
Marianne Hajjar, 516604242, marianne.hajjar@chu-poitiers.fr
- Recruiting
Pôle de Santé et Prevention du Clion
Pornic, Loire Atlantiue, 44210
Cedric Rat, MD, 0240820075, cedric.rat@univ-nantes.fr
Emilie Guegan, 253526332, emilie.guegan@chu-nantes.fr
- Recruiting
CHU de Toulouse
Toulouse, Occitanie, 31059
Meyer Elbaz, MD, 0561323649, elbaz.m@chu-toulouse.fr
Bérangère BACHELET, "bachelet.b@chu-toulouse.fr
- Recruiting
Centre de santé Kersanté Toulouse La Terrasse
Toulouse, Occitanie, 31500
Pierrik FOSTIER, 0582950207, pierrik.fostier@wanadoo.fr
- Recruiting
Maison de Santé Pluriprofessionnelle Universitaire LA PROVIDENCE
Toulouse, Occitanie, 31500
Marie-Eve ROUGE-BUGAT, 05 61 80 01 23, marieeve.rouge-bugat@dumg-toulouse.fr
Marie VAYSSETTES, 0672157855, marie.vayssettes@dumg-toulouse.fr
- Recruiting
MSP Ty santé Vannes Tohannic
Vannes, Brittany Region, 56000
Charlotte GRIMAULT, MD, 0676742244, charlotte.grimault@univ-nantes.fr
Emilie GUEGAN, 0253526332, emilie.guegan@chu-nantes.fr
- Recruiting
MSPU la Source
Vergèze, Gard, 30310
Chloé SIKIRDJI, MD, 04 66 80 72 01, "chloe.sikirdji@umontpellier.fr
Frieda TAMOUTE, 608869613, frieda.tamoute@umontpellier.fr
Italy11 sites, 11 recruiting
- Recruiting
Ospedale Miulli U.O.C. Endocrinologia
Acquaviva delle Fonti, Bari, 70021
Lucrezia Matera, MD, 080/3054263, l.matera@miulli.it
- Recruiting
Ospedali Riuniti Clinica Di Cardiologia E Aritmologia
Ancona, The Marches, 60122
Giuseppe Ciliberti, MD, 071/5965798, giuseppe.ciliberti@ospedaliriuniti.marche.it
Niki Tombolesi, 351/6186110, niki.tombolesi@ospedaliriuniti.marche.it
- Recruiting
Ospedale A. Cardarelli Sc Diabetologia Ed Endocrinologia
Campobasso, 86100
Maria Rosaria Cristofaro, MD, 0874/4091, mariarosaria.cristofaro@asrem.molise.it
- Recruiting
Dipartimento Cure Primarie Diabetologia Territoriale
Ferrara, Emilia-Romagna, 44100
Marcello Monesi, MD, 339/1494908, m.monesi@ausl.fe.it
- Recruiting
Ospedale San Giovanni Di Dio, U.O. Diabetologia E Malatt. Metaboliche
Florence, Tuscany, 50124
Cristiana Baggiore, MD, 055/7192265, cristianamaria.baggiore@uslcentro.toscana.it
Michela Cameron Smith, 339/7688716, michela.cameronsmith@usltoscana.centro.it
- Recruiting
Policlinico Riuniti U.O. Di Diabetologia
Foggia, Apulia, 71100
Olga Lamacchia, MD, 349/4209175, olga.lamacchia@unifg.it
Chiara Corsano, MD, 347/2579078, chiara.corsano@unifg.it
- Recruiting
Adiabetologiasst Ospedale Metropolitano Niguarda
Milan, Lombardy, 20162
Basilio Pintaudi, MD, 328/7858855, basilio.pintaudi@ospedaleniguarda.it
Matteo Conti, MD, 346/6825970, matteo.conti2@ospedaleniguarda.it
- Recruiting
Ftgm - Stabilimento Di Pisa Uos Vd Attivita Ambulatoriali E Ospedale Diurno
Pisa, Tuscany, 56124
Giuseppe Vergaro, MD, 349/6105539, vergaro@ftgm.it
Kyriazoula Chatzianagnostou, 348/7362549, zulachat@ftgm.it
- Recruiting
Ospedale San Jacopo Sezione Di Diabetologia
Pistoia, Tuscany, 51100
Roberto Anichini, MD, 338/9644876, roberto.anichini@uslcentro.toscana.it
Chiara Delle Poggi, MD, 338/5242866, chiara.dellipoggi@uslcentro.toscana.it
- Recruiting
Ospedale Civile Santa Maria Delle Croci U.O. Diabetologia
Ravenna, Emilia-Romagna, 48100
Paolo Di Bartolo, MD, 335/429555, paolo.dibartolo@auslromagna.it
- Recruiting
"Ospedale Oftalmico S.C. Endocrinologia E Metaboliche"
Turin, Piedmont, "10122
Salvatore Oleandri, MD, 333/6121004, salvatore.oleandri@aslcittaditorino.it
Portugal3 sites, 3 recruiting
- Recruiting
Unidade de Saúde Local Amadora-Sintra
Amadora, 2700-000
Sergio Baptista, MD, 962364061, sergio.b.baptista@gmail.com
Maura Nedio, maura.c.medio@ulsasi.min-saude.pt
- Recruiting
Hospital de Luz Lisboa
Lisbon, 1500-650
Anabela Raimundo, MD, +351 936 391 728, araimundo@hospitaldaluz.pt
Miguel Ribeiro, +351 969 730 400, miguel.rabasquinho.ribeiro@luzsaude.pt
- Recruiting
Unidade Local de Saue Santa Maria, EPE
Lisbon, 1649-035
Fausto Pinto, MD, fausto.pinto@medicina.ulisboa.pt
Margarida Batista, +351919682943, margarida.batista@medicina.ulisboa.pt
Canada2 sites, 2 recruiting
- Recruiting
Montreal Heart Institute
Montreal, Quebec
Jessica Drouin, 514-376-3330 ext. 3450, Jessica.Drouin@icm-mhi.org
Nancy Fernandez, 514-376-3330 ext. 2235, Nancy.Fernandez@icm-mhi.org
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Andrew Pinto, MD, 416-864-6060 ext. 41613, andrew.pinto@utoronto.ca
Paolo Marcelo, 416-360-4000 ext. 41613, paolo.marcelo@unityhealth.to
Australia1 site, 1 recruiting
- Recruiting
Curtin University
Bentley, Western Australia, 6102
Chrsitopher Reid, MD, +61892667123, christopher.reid@curtin.edu.au
Amy Ward, +61892669128, amy.ward@curtin.edu.au
Denmark1 site, 1 recruiting
- Recruiting
Center for Translational Cardiology and Pragmatic Randomized Trial
Hellerup, 2900
Tor Biering-Sorensen, MD, +45 28933590, tor.biering@gmail.com
Finland1 site, 1 recruiting
- Recruiting
Heart and Lung Center, Helsinki University Hospital and Helsinki University
Helsinki, 00029
Juha Sinisalo, MD, +358504279007, juha.sinisalo@hus.fi
Charlotta Henriksson, +358 40 588 2531, ext-charlotta.henriksson@hus.fi
Greece1 site, 1 recruiting
- Recruiting
Evgenidion Clinic "Agia Trias" S.A.
Athens, 11528
Spyridon Deftereos, MD, +30 21 0720 8100
About this study
Official title: 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.
- Conditions
- Diabete Type 2, Cardiovascular Diseases
- Being tested
- Aspirin, Aspirin Placebo, Colchicine, Colchicine Placebo
- Keywords
- Diabetes (Type 2), Heart Disease
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
40 mg non-enteric-coated tablet taken twice daily.
Aspirin PlaceboDrug
non-enteric-coated tablet taken twice daily.
ColchicineDrug
0.5 mg tablet taken once daily
Colchicine PlaceboDrug
tablet taken once daily.
| Study group | Role | What they receive |
|---|---|---|
| Anti-thrombotic arm | Active comparator | For patients eligible for aspirin therapy arm. Receives: Drug: Aspirin; Drug: Aspirin Placebo; Drug: Colchicine; Drug: Colchicine Placebo |
| Anti-thrombotic arm (Placebo) | Placebo comparator | For patients eligible for aspirin therapy arm. Receives: Drug: Aspirin; Drug: Aspirin Placebo; Drug: Colchicine; Drug: Colchicine Placebo |
| Anti-inflammatory arm | Active comparator | For patients ineligible for aspirin therapy arm. Receives: Drug: Colchicine; Drug: Colchicine Placebo |
| Anti-inflammatory arm (Placebo) | Placebo comparator | For patients ineligible for aspirin therapy arm. Receives: Drug: Colchicine; Drug: Colchicine Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization to occurrence of first event, assessed up to 60 months.
Secondary outcomes (9)
Cardiovascular Death
The number of participants having a cardiovascular death.
Measured: From randomization to cardiovascular death, assessed up to 60 months.
First Event of Resuscitated Cardiac Arrest
The number of participants having at least 1 resuscitated cardiac arrest.
Measured: From randomization to event, assessed up to 60 months.
First Event of Non-fatal Myocardial Infarction
The number of participants having at least 1 myocardial infarction.
Measured: From randomization to event, assessed up to 60 months.
First Event of Non-fatal Stroke
The number of participants having at least 1 stroke.
Measured: From randomization to event, assessed up to 60 months
First Occurrence of Urgent Hospitalization for Angina Requiring Coronary Revascularization
The number of participants having at least 1 urgent hospitalization for angina requiring coronary revascularization.
Measured: From randomization to occurrence, assessed up to 60 months.
First Event of Atrial Fibrillation
The number of participants having at least 1 atrial fibrillation.
Measured: From randomization to event, assessed up to 60 months.
First Occurrence of Heart Failure Hospitalization
The number of participants having at least 1 heart failure hospitalization.
Measured: From randomization to occurrence, assessed up to 60 months.
First Occurrence of Coronary Revascularization
The number of participants having at least 1 coronary revascularization.
Measured: From randomization to occurrence, assessed up to 60 months.
MoCA Scores Assessed Over Time
Change from randomization in MoCA score at yearly follow-ups (excluding the first-year visit) until the end-of-study visit.
Measured: From randomization to yearly follow-ups until the end-of-study visit, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start21 Dec 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633810
- Sponsor's protocol ID
- MHICC-2021-001
- Acronym
- COLCOT-T2D
- Status last verified
- Oct 2026
- First submitted
- 11 Nov 2022
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COLchicine and Non-enteric Coated Aspirin in the Cardiovascular Outcomes Trial of Patients With Type 2 Diabetes (COLCOT-T2D)
- ClinicalTrials.gov ID
- NCT05633810
- Acronym / sponsor ID
- COLCOT-T2D / MHICC-2021-001
- Conditions
- Diabete Type 2, Cardiovascular Diseases
- Keywords
- Diabetes (Type 2), Heart Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Anti-thrombotic arm | Active comparator | Drug: Aspirin, Drug: Aspirin Placebo, Drug: Colchicine, Drug: Colchicine PlaceboFor patients eligible for aspirin therapy arm. |
| Anti-thrombotic arm (Placebo) | Placebo comparator | Drug: Aspirin, Drug: Aspirin Placebo, Drug: Colchicine, Drug: Colchicine PlaceboFor patients eligible for aspirin therapy arm. |
| Anti-inflammatory arm | Active comparator | Drug: Colchicine, Drug: Colchicine PlaceboFor patients ineligible for aspirin therapy arm. |
| Anti-inflammatory arm (Placebo) | Placebo comparator | Drug: Colchicine, Drug: Colchicine PlaceboFor patients ineligible for aspirin therapy arm. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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:
- 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.
Key exclusion criteria (24 listed)
- 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
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin40 mg non-enteric-coated tablet taken twice daily. | Drug | Anti-thrombotic arm, Anti-thrombotic arm (Placebo) |
| Aspirin Placebonon-enteric-coated tablet taken twice daily. | Drug | Anti-thrombotic arm, Anti-thrombotic arm (Placebo) |
| Colchicine0.5 mg tablet taken once daily | Drug | Anti-inflammatory arm, Anti-inflammatory arm (Placebo), Anti-thrombotic arm, Anti-thrombotic arm (Placebo) |
| Colchicine Placebotablet taken once daily. | Drug | Anti-inflammatory arm, Anti-inflammatory arm (Placebo), Anti-thrombotic arm, Anti-thrombotic arm (Placebo) |
Primary outcome
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.
9 secondary outcomes
Cardiovascular Death
Time frame: 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.
First Event of Non-fatal Myocardial Infarction
Time frame: 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
First Occurrence of Urgent Hospitalization for Angina Requiring Coronary Revascularization
Time frame: 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.
First Occurrence of Heart Failure Hospitalization
Time frame: 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.
MoCA Scores Assessed Over Time
Time frame: From randomization to yearly follow-ups until the end-of-study visit, assessed up to 60 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Claude Tardif, MD, FRCPC, FACC, FCAHS contact
39 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aspirin and Colchicine in people with Diabete Type 2 and Cardiovascular Diseases, run by Montreal Heart Institute at 39 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in France, Italy, Portugal, Canada, Australia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Claude Tardif, MD, FRCPC, FACC, FCAHS (514-376-3330 ext. 3612, Jean-Claude.Tardif@icm-mhi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.