COLchicine and Non-enteric Coated Aspirin in the Cardiovascular Outcomes Trial of Patients With Type 2 Diabetes
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age55-80
SponsorMontreal Heart Institute
About this trial
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.
Eligibility criteria
Qualifiers
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
Duration of diabetes of 5 years or more,
Disqualifiers
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
Trial design
Treatments tested in this trial
- Aspirin
- Aspirin Placebo
- Colchicine
- Colchicine Placebo
Treatment groups
10,000 Participants
are divided into 4 treatment groupsLocations
39Australia
Curtin University6102, BentleyWestern Australia, Australia
Canada
St. Michael's HospitalM5B 1W8, TorontoOntario, Canada
Montreal Heart Institute MontrealQuebec, Canada
Denmark
Center for Translational Cardiology and Pragmatic Randomized Trial2900, Hellerup Denmark
Sponsors and collaborators
Montreal Heart Institute
Lead sponsor
Source ClinicalTrials.gov