COLchicine and Non-enteric Coated Aspirin in the Cardiovascular Outcomes Trial of Patients With Type 2 Diabetes
Trial Parameters
Brief Summary
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
Inclusion Criteria: 1. Men and women aged 55 to 80 years 2. Type 2 diabetes treated as per national guidelines 3. No previous history of coronary artery disease-related clinical event 4. And at least one of the following: 1. Duration of diabetes of 5 years or more, 2. HbA1c ≥ 8.0% or more in the last 2 years 3. Active cigarette smoking, 4. High hs-CRP (\> 2.0 mg/L), 5. High coronary calcium score (Agatston score \>100), 6. High TG-levels (≥1.7 mmol/L) despite lipid lowering therapy administered as per guidelines, 7. High LDL-C levels (≥3.5 mmol/L) or high non-HDL-C levels (≥4.2 mmol/L) despite lipid lowering therapy administered as per guidelines 8. High Apo-B (≥1.05 g/L) 9. Reduced HDL-C (\<1.05 mmol/L in men, \<1.3 mmol/L in women), 10. Lp(a) \>50 mg/dL, 11. Peripheral artery disease with stenosis ≥50% or prior revascularization, 12. Cerebrovascular disease with stenosis ≥50% or prior revascularization, 13. Diabetic retinopathy or diabetic neuropathy, 14. Mild or moderate proteinuria