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.
Age ≥ year
Diabetes mellitus, on treatment or new diagnosis with HbA1c ≥6.5%
Current smoking
Women who are pregnant, breastfeeding, or of childbearing potential who are not using an effective method of contraception. Or women who intend to donate oocytes.
Men who plan to father children during the study period or who are unwilling to use effective forms of contraception. Or men who intend to donate sperm.
Any contraindication or known intolerance to colchicine.
Chronic use of -or need for- colchicine.
Parallel
Colchicine 0.5 MG Oral Tablet
DrugOral intake of 0.5 mg colchicine once daily
Placebo
DrugOral intake of matching placebo once daily
Time from randomisation to first occurrence of a composite endpoint consisting of: all-cause death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke, or coronary revascularisation.
Time from randomisation to first occurrence of a composite of specific cardiovascular endpoints
Time from randomisation to first occurrence of a composite of: cardiovascular death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B \& C), non-fatal stroke or coronary revascularisation
Time from randomisation to first occurrence of a composite of hard endpoints consisting of: all-cause death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke
Time from randomisation to first occurrence of breakdown components of primary endpoint and atherosclerosis-related diseases
Time from randomisation to first occurrence of: all-cause death, cardiovascular death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B \& C), non-fatal stroke, coronary revascularisation, ischemia driven coronary revascularisation, stent thrombosis, peripheral artery revascularisation, transient ischemic attack (TIA) treated with carotid revascularisation
Time from randomisation to occurrence of first as well as recurrent endpoints consisting of: all-cause death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke, or coronary revascularisation.
Change from randomisation to year 1 (and year 2 if available): in hsCRP as a measure of Inflammation.
Change from randomisation to year 1 (and year 2 if available) in blood lab results from: (high sensitivity) C-reactive protein (mg/dl)
Change from randomisation to year 1 (and year 2 if available): in white blood cell count as a measure of Inflammation.
Change from randomisation to year 1 (and year 2 if available) in blood lab results from: white blood cell count (/μl)
Change from randomisation to year 1 (and year 2 if available) in total cholesterol.
Change from randomisation to year 1 (and year 2 if available) in blood lab results from: total cholesterol (mg/dl)
Change from randomisation to year 1 (and year 2 if available) in low density lipoprotein.
Change from randomisation to year 1 (and year 2 if available) in blood lab results from: low density lipoprotein (LDL) (mg/dl)
Click on the lead sponsor to view all of their trials.
AZ Sint-Jan AV
Lead sponsor
University Hospital, Ghent
Collaborator
Belgium Health Care Knowledge Centre
Collaborator
