Different Doses of Colchicine on hsCRP

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Different Doses of Colchicine on High-sensitivity C-reactive Protein in Patients After Percutaneous Coronary Intervention

Conditions
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Coronary Artery Disease, Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: Colchicine 0.5 MG
* Drug: Colchicine 0.375 MG
* Drug: Colchicine 0.25 MG
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteer to participate, understand and sign an informed consent form; Age ≥ 18 years old, regardless of gender; Patient diagnosed with coronary heart disease requiring percutaneous coronary intervention; Complete all planned percutaneous coronary intervention during hospitalization; Patient must be treated according to national guidelines for standard treatment of coronary heart disease. Exclusion Criteria: Known allergies to colchicine; Colchicine was taken within 10 days before randomization; Abnormal liver function test (alanine aminotransferase >3 times the upper limit of normal value); Abnormal renal function test (eGFR<30mL/min); Thrombocytopenia (platelet count <100 g/L); Uncontrolled infectious diseases; Known immune diseases or immune-related diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, and malignant tumor, etc; Pre-existing or plan for the administration of nonsteroidal anti-inflammatory drugs, hormones, immunomodulatory drugs, or chemotherapeutic drugs; Pregnant women, lactating women or women of childbearing age who do not use effective contraceptives; Any other circumstances in which the investigator judges that the patient is not suitable to participate in the clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Colchicine 0.5 MG<br>Colchicine 0.5 MG, one pill a day, oral intake | Drug: Colchicine 0.5 MG<br>* Colchicine 0.5 MG, one pill a day, oral intake<br>|
| Active Comparator: Colchicine 0.375 MG<br>Colchicine 0.375 MG, one pill a day, oral intake | Drug: Colchicine 0.375 MG<br>* Colchicine 0.375 MG, one pill a day, oral intake<br>|
| Active Comparator: Colchicine 0.25 MG<br>Colchicine 0.25 MG, one pill a day, oral intake | Drug: Colchicine 0.25 MG<br>* Colchicine 0.25 MG, one pill a day, oral intake<br>|
| Placebo Comparator: Placebo<br>Placebo, one pill a day, oral intake | Drug: Placebo<br>* Placebo, one pill a day, oral intake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage change in hsCRP | The percentage change in hsCRP compared to baseline | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 weeks | 
| Bleeding | Bleeding defined according to Bleeding Academic Research Consortium | 4 weeks | 
| Plasma inflammatory cytokines level | Inflammatory cytokines (IL-1β, IL-1receptor antagonist, IL-6, IL-18, tumor necrosis factor-α, myeloperoxidase, etc) | 4 weeks | 
| Blood drug concentrations of different doses of colchicine | Blood drug concentrations of different doses of colchicine | 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) | 4 weeks |