The Effects of Different Doses of Colchicine on High-sensitivity C-reactive Protein in Patients After Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The percentage change in hsCRP
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Colchicine 0.375 MG
Colchicine 0.375 MG, one pill a day, oral intake
干预措施: Colchicine 0.375 MG (Drug)
Colchicine 0.5 MG
Colchicine 0.5 MG, one pill a day, oral intake
干预措施: Colchicine 0.5 MG (Drug)
Colchicine 0.25 MG
Colchicine 0.25 MG, one pill a day, oral intake
干预措施: Colchicine 0.25 MG (Drug)
Placebo
Placebo, one pill a day, oral intake
干预措施: Placebo (Drug)
结局指标
主要结局
The percentage change in hsCRP
时间窗: 4 weeks
The percentage change in hsCRP compared to baseline
次要结局
- Bleeding(4 weeks)
- Major adverse cardiac and cerebrovascular event (MACCE)(4 weeks)
- Plasma inflammatory cytokines level(4 weeks)
- Blood drug concentrations of different doses of colchicine(4 weeks)
- Expression of inflammation-related proteins in peripheral blood mononuclear cells(4 weeks)
研究者
Xiang Cheng
Director in the department of cardiology
Wuhan Union Hospital, China