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 participate
Age range55 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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
✓. And at least one of the following:
✓. Duration of diabetes of 5 years or more,
✓. HbA1c ≥ 8.0% or more in the last 2 years
✓. Active cigarette smoking,
✓. High hs-CRP (\> 2.0 mg/L),
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
✕
What they're measuring
1
First event of the composite of cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, or urgent hospitalization for angina requiring coronary revascularization.
Timeframe: From randomization to occurrence of first event, assessed up to 60 months.
. 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: