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 groupsSponsors and collaborators
Source ClinicalTrials.gov