About this trial
The aim of this prospective cohort study was to investigate the multi-omics characteristics of the efficacy of colchicine treatment in patients with ACS and to construct a model of efficacy. The main questions the study aims to answer are
\- Specific mechanisms of colchicine therapy in patients with ACS; Mechanism-based modelling to identify the population that benefits from colchicine treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Between the ages of 18 and 80
ACS (STEMI or NSTE-ACS)
Patients to receive standardised drug therapy
Able and willing to provide informed consent
Disqualifiers
Any contraindication to colchicine or known intolerance to colchicine
Has been using colchicine for a prolonged period of time for other medical conditions
Women of childbearing age who are pregnant, breastfeeding or not using effective contraception
Coronary artery bypass grafting within the last 3 years or planned
Trial design
Parallel
Treatments tested in this trial
Colchicine 0.5 MG Oral Tablet Once Daily
DrugColchicine 0.5 MG Oral Tablet Once Daily
Treatment groups
Trial outcomes
Primary outcomes
Number of responder
1. Resolution of Inflammation: A reduction in high-sensitivity C-reactive protein (hs-CRP) levels to \<2.0 mg/L, or a decrease of ≥50% from baseline. 2. Clinical Stability: No occurrence of major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, or urgent revascularization. 3. Ventricular Remodeling: This is assessed by parameters such as ventricular volume, wall thickness, left ventricular mass, and LVEF (Left Ventricular Ejection Fraction), measured by cardiac magnetic resonance (CMR) or echocardiography.
Number of Participants with Advances in Coronary Artery Physiology and Function
Comparing the change in coronary QFR at baseline and one-year follow-up, the sum of QFR of the three major coronary vessels (anterior descending, circumflex, and right coronary artery) was calculated (3V-QFR), and progression in coronary physiology was defined when 3V-QFR minus baseline 3V-QFR at follow-up was ≤ -0.05
Secondary outcomes
Incidence of MACE within one year
MACE defined as: death (cardiac or non-cardiac), acute myocardial infarction, stroke, ischaemia-driven haemodialysis
Sponsors and contacts
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