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Could a common gout pill and baby aspirin shield diabetic hearts?

NCT ID NCT05633810

Disease control Sponsor: Montreal Heart Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This large phase 3 trial is testing whether colchicine (a gout medication) and low-dose aspirin, taken together or alone, can prevent heart attacks, strokes, and cardiac death in 10,000 high-risk people with type 2 diabetes who have not yet had a heart-related event. Participants are aged 55–80 and have additional risk factors like long-standing diabetes, smoking, or high inflammation. The study aims to see if these inexpensive drugs can reduce cardiovascular complications in this vulnerable group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
colchicine and low-dose aspirin
What this could lead to
If successful, this could provide a simple, affordable way to reduce major cardiovascular events in people with type 2 diabetes who have not yet had a heart attack or stroke.
What could go wrong
This is a large phase 3 trial, but previous studies of anti-inflammatory drugs in diabetes have had mixed results. Colchicine can cause gastrointestinal side effects, and aspirin increases bleeding risk. The benefits may be modest or not outweigh the risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 10,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder heart disorder type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases Diabete type 2

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    39 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • "Ospedale Oftalmico S.C. Endocrinologia E Metaboliche"

    RECRUITING

    Turin, Piedmont, "10122, Italy

  • Adiabetologiasst Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, Lombardy, 20162, Italy

  • CHU de Montpellier

    RECRUITING

    Montpellier, Occitanie, 34090, France

  • CHU de Nantes

    RECRUITING

    Nantes, Pays de la Loire Region, 44093, France

  • CHU de Nîmes

    RECRUITING

    Nîmes, Occtanie, 30029, France

  • CHU de Poitiers

    RECRUITING

    Poitiers, New Aquitaine, 86021, France

  • CHU de Toulouse

    RECRUITING

    Toulouse, Occitanie, 31059, France

  • CMS Salvador Allende

    RECRUITING

    La Courneuve, Seine-Saint-Denis, 93120, France

  • Cabinet médical Les Oiseaux

    RECRUITING

    Morsang-sur-Orge, 91930, France

  • Center for Translational Cardiology and Pragmatic Randomized Trial

    RECRUITING

    Hellerup, 2900, Denmark

  • Centre Medical Villa Ravas

    RECRUITING

    Montpellier, Occitanie, 34080, France

  • Centre de santé Kersanté Rosa Parks

    RECRUITING

    Paris, 75019, France

  • Centre de santé Kersanté Toulouse La Terrasse

    RECRUITING

    Toulouse, Occitanie, 31500, France

  • Curtin University

    RECRUITING

    Bentley, Western Australia, 6102, Australia

  • Dipartimento Cure Primarie Diabetologia Territoriale

    RECRUITING

    Ferrara, Emilia-Romagna, 44100, Italy

  • Evgenidion Clinic "Agia Trias" S.A.

    RECRUITING

    Athens, 11528, Greece

  • Ftgm - Stabilimento Di Pisa Uos Vd Attivita Ambulatoriali E Ospedale Diurno

    RECRUITING

    Pisa, Tuscany, 56124, Italy

  • Heart and Lung Center, Helsinki University Hospital and Helsinki University

    RECRUITING

    Helsinki, 00029, Finland

  • Hospital de Luz Lisboa

    RECRUITING

    Lisbon, 1500-650, Portugal

  • MSP Noirmoitier

    RECRUITING

    Noirmoutier-en-l'Île, Pays de la Loire Region, 85330, France

  • MSP Ty santé Vannes Tohannic

    RECRUITING

    Vannes, Brittany Region, 56000, France

  • MSPU Pins Justaret

    RECRUITING

    Pins-Justaret, Haute-Garonne, 31860, France

  • MSPU la Source

    RECRUITING

    Vergèze, Gard, 30310, France

  • MSPU la collégiale

    RECRUITING

    Poissy, Yvelines, 78300, France

  • Maison de Santé Pluriprofessionnelle OLEA

    RECRUITING

    Bezouce, Gard, 30320, France

  • Maison de Santé Pluriprofessionnelle Universitaire LA PROVIDENCE

    RECRUITING

    Toulouse, Occitanie, 31500, France

  • Maison de Santé du Sud Ruthénois

    RECRUITING

    Luc-la-Primaube, Aveyron, 12450, France

  • Montreal Heart Institute

    RECRUITING

    Montreal, Quebec, Canada

  • Ospedale A. Cardarelli Sc Diabetologia Ed Endocrinologia

    RECRUITING

    Campobasso, 86100, Italy

  • Ospedale Civile Santa Maria Delle Croci U.O. Diabetologia

    RECRUITING

    Ravenna, Emilia-Romagna, 48100, Italy

  • Ospedale Miulli U.O.C. Endocrinologia

    RECRUITING

    Acquaviva delle Fonti, Bari, 70021, Italy

  • Ospedale San Giovanni Di Dio, U.O. Diabetologia E Malatt. Metaboliche

    RECRUITING

    Florence, Tuscany, 50124, Italy

  • Ospedale San Jacopo Sezione Di Diabetologia

    RECRUITING

    Pistoia, Tuscany, 51100, Italy

  • Ospedali Riuniti Clinica Di Cardiologia E Aritmologia

    RECRUITING

    Ancona, The Marches, 60122, Italy

  • Policlinico Riuniti U.O. Di Diabetologia

    RECRUITING

    Foggia, Apulia, 71100, Italy

  • Pôle de Santé et Prevention du Clion

    RECRUITING

    Pornic, Loire Atlantiue, 44210, France

  • St. Michael's Hospital

    RECRUITING

    Toronto, Ontario, M5B 1W8, Canada

  • Unidade Local de Saue Santa Maria, EPE

    RECRUITING

    Lisbon, 1649-035, Portugal

  • Unidade de Saúde Local Amadora-Sintra

    RECRUITING

    Amadora, 2700-000, Portugal

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