Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
NCT Number: NCT06078904
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Wuhan, Hubei, 430022, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 4 weeks
The percentage change in hsCRP compared to baseline
Time frame: 4 weeks
Composite endpoint of all cause death, non fatal myocardial infarction, non fatal stroke, and revascularization due to ischemia
Time frame: 4 weeks
Bleeding defined according to Bleeding Academic Research Consortium
Time frame: 4 weeks
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
Time frame: 4 weeks
Inflammation-related proteins (nucleotide-binding oligomerization domain-like receptor protein 3, absent in melanoma 2, etc)
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Other
The Effects of Different Doses of Colchicine on High-sensitivity C-reactive Protein in Patients After Percutaneous Coronary Intervention
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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