An interventional study of Colchicine 0.5 MG Oral Tablet Once Daily in ACS - Acute Coronary Syndrome, sponsored by Shanghai Tongji Hospital, Tongji University School of Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by Shanghai Tongji Hospital, Tongji University School of Medicine · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Adding low-dose colchicine on the basis of standardized treatment
Drug: Colchicine 0.5 MG Oral Tablet Once Daily
Standardized treatment
Colchicine 0.5 MG Oral Tablet Once Daily
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.
Time frame: 6 months after enrolment
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
Time frame: 1 year after enrolment
Incidence of MACE within one year
MACE defined as: death (cardiac or non-cardiac), acute myocardial infarction, stroke, ischaemia-driven haemodialysis
Time frame: 1 year after enrolment
Plan to share: No
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Shanghai Tongji Hospital, Tongji University School of Medicine