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

NCT ID NCT05633810

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

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.

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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

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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