This trial is designed to evaluate whether low-dose colchicine, in addition to standard treatment recommended by guidelines, further reduces the risk of major adverse cardiovascular events in patients with acute coronary syndromes (ACS) through a prospective, randomized, double-blind, placebo-controlled clinical trial.
Age ≥ 18 years;
Definite diagnosis of ACS;
Ability and willingness to provide written informed consent
Type 2 myocardial infarction (Patients with symptoms or signs of myocardial ischemia and evidence of increased oxygen demand or decreased supply [for example, tachyarrhythmia, hypotension, or anaemia] secondary to an alternative pathology and myocardial necrosis are defined as suffering type 2 myocardial infarction. The classification of type 2 myocardial infarction also includes patients with coronary vasospasm, embolism or spontaneous dissection without evidence of atherothrombosis related to coronary artery disease);
Valvular heart disease that is considered likely to require surgical intervention;
History of non-skin cancer in the past 3 years;
Inflammatory bowel disease or chronic diarrhea;
Parallel
Colchicine Pill
DrugColchicine 0.5mg once daily will be given on the basis of standard treatment of ACS recommended by guidelines
Placebo
DrugPlacebo one tablet once daily will be given on the basis of standard treatment of ACS recommended by guidelines
Primary endpoint
Rate of the composite of cardiovascular death, non-fatal ischemic stroke, non-fatal spontaneous (non-operation related) myocardial infarction, readmission for ACS, and ischaemia driven (unplanned) revascularization
Key secondary endpoint
Rate of the composite of cardiovascular death, non-fatal ischemic stroke, and non-fatal spontaneous (non-operation related) myocardial infarction
Secondary endpoint 1
Rate of all-cause death
Secondary endpoint 2
Rate of cardiovascular death
Secondary endpoint 3
Rate of non-fatal ischemic stroke
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