Colchicine reduced atherothrombotic cardiovascular events in the COLCOT and LoDoCo2 studies. US Food and Drug Administration approved colchicine as the first anti-inflammatory drug for cardiovascular diseases on June, 2023. However, there is a lack of evidence for colchicine in East Asian population with coronary heart disease, and its effectiveness and safety need further exploration. Therefore, this study aims to use different doses of colchicine to treat patients with coronary heart disease after percutaneous coronary intervention, explore the effects of different doses of colchicine on hsCRP levels, and find the optimal dose of colchicine for treating coronary heart disease in China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Colchicine 0.5 MG, one pill a day, oral intake
Colchicine 0.375 MG, one pill a day, oral intake
Colchicine 0.25 MG, one pill a day, oral intake
Placebo, one pill a day, oral intake
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The percentage change in hsCRP
The percentage change in hsCRP compared to baseline
Time frame: 4 weeks
Major adverse cardiac and cerebrovascular event (MACCE)
Composite endpoint of all cause death, non fatal myocardial infarction, non fatal stroke, and revascularization due to ischemia
Time frame: 4 weeks
Bleeding
Bleeding defined according to Bleeding Academic Research Consortium
Time frame: 4 weeks
Plasma inflammatory cytokines level
Inflammatory cytokines (IL-1β, IL-1receptor antagonist, IL-6, IL-18, tumor necrosis factor-α, myeloperoxidase, etc)
Time frame: 4 weeks
Blood drug concentrations of different doses of colchicine
Blood drug concentrations of different doses of colchicine
Time frame: 4 weeks
Expression of inflammation-related proteins in peripheral blood mononuclear cells
Inflammation-related proteins (nucleotide-binding oligomerization domain-like receptor protein 3, absent in melanoma 2, etc)
Time frame: 4 weeks
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