🏛️ Verified NIH Record • Updated 2026-03-09

COLchicine and Non-enteric Coated Aspirin in the Cardiovascular Outcomes Trial of Patients With Type 2 Diabetes (NCT05633810)

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Montreal Heart Institute

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (22 items) and avoid the listed exclusions (25 items).

Location: Curtin University — Bentley, Western Australia

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • 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
  • 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)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (39 Sites)

  • Curtin University — Bentley, Western Australia
  • St. Michael's Hospital — Toronto, Ontario
  • Montreal Heart Institute — Montreal, Quebec
  • Center for Translational Cardiology and Pragmatic Randomized Trial — Hellerup,
  • Heart and Lung Center, Helsinki University Hospital and Helsinki University — Helsinki,
  • Maison de Santé du Sud Ruthénois — Luc-la-Primaube, Aveyron
  • MSP Ty santé Vannes Tohannic — Vannes, Brittany Region
  • Maison de Santé Pluriprofessionnelle OLEA — Bezouce, Gard
  • MSPU la Source — Vergèze, Gard
  • MSPU Pins Justaret — Pins-Justaret, Haute-Garonne
  • Pôle de Santé et Prevention du Clion — Pornic, Loire Atlantiue
  • CHU de Poitiers — Poitiers, New Aquitaine
  • Centre Medical Villa Ravas — Montpellier, Occitanie
  • CHU de Montpellier — Montpellier, Occitanie
  • CHU de Toulouse — Toulouse, Occitanie
  • Centre de santé Kersanté Toulouse La Terrasse — Toulouse, Occitanie
  • Maison de Santé Pluriprofessionnelle Universitaire LA PROVIDENCE — Toulouse, Occitanie
  • CHU de Nîmes — Nîmes, Occtanie
  • CHU de Nantes — Nantes, Pays de la Loire Region
  • MSP Noirmoitier — Noirmoutier-en-l'Île, Pays de la Loire Region
  • CMS Salvador Allende — La Courneuve, Seine-Saint-Denis
  • MSPU la collégiale — Poissy, Yvelines
  • Cabinet médical Les Oiseaux — Morsang-sur-Orge,
  • Centre de santé Kersanté Rosa Parks — Paris,
  • Evgenidion Clinic "Agia Trias" S.A. — Athens,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗