Colchicine in Belgium in Patients With Coronary Artery Disease
The main aim of this trial is to determine whether there are fewer cardiovascular events when patients with coronary artery disease take a low dose of colchicine of 0.5 mg daily on top of optimal standard treatment after treatment with PCI, compared with placebo in combination with optimal standard treatment. More specifically, we aim to investigate the benefits of a daily low dose of colchicine in patients with coronary artery disease after treatment with PCI, to confirm that a daily low dose of colchicine helps prevent additional incidents in coronary artery disease, and to identify a subgroup of patients with CAD who are at increased risk for cardiovascular events and could benefit most from colchicine.
• Age ≥45 years.
• Coronary artery disease treated with PCI and optimal medical therapy, with at least one additional risk factor (based on SMART):
‣ Age ≥ year
⁃ Diabetes mellitus, on treatment or new diagnosis with HbA1c ≥6.5%
⁃ Current smoking
⁃ Treated hypertension or lood pressure systolic ≥ 4 mmHg or diastolic ≥ mmHg
⁃ Total cholesterol \>240 mg/dl untreated, or treated LDL \>70 mg/dl
⁃ HDL \<40 mg/dl
⁃ hsCRP \>2 mg/L AND chronic coronary syndrome (CCS)
⁃ eGFR \<60 ml/min (MDRD)
⁃ history of vascular disease:
• CAD (PCI prior to index, CABG, MI)
∙ stroke (ischemic or hemorrhagic)
∙ carotid artery revascularisation
∙ PAD (revascularisation, ABI \<0.85 at rest, amputation due to atherosclerotic disease)
∙ AAA (repair, distal aortic anteroposterior diameter \>3.0cm)
• Able to be enrolled/randomized between 2 hour and 5 days post PCI.
• Written informed consent.