The Efficacy and Safety of Colchicine in Improving the Stability of Coronary Plaque in Patients With Acute Coronary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- changes of the Thickness of fibrous cap of coronary artery plaque
研究概览
简要总结
Evidence from the COLCOT Trial has shown that anti-inflammatory effect of colchicine reduced the risk of cardiovascular events in patients with recent myocardial infarction. We hypothesized that this might be due to the improvement of the coronary plaque stability by colchicine. Optical coherence tomography (OCT) is the most precise method to detect plaque stability in clinical practice. Thus, the purpose of this study is to evaluate the efficacy and safety of colchicine on improving the stability of coronary plaque in patients with acute coronary syndrome.
详细描述
This is a single-center, randomized, double-blind, placebo-controlled clinical trial. OCT coronary images analyzed at an independent imaging core laboratory (Department of Cardiology, Second Affiliated Hospital of Harbin Medical University, Harbin, China) by blinded expert readers.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who understand and sign the informed consent form voluntarily.
- •Age ≥ 18 years old and ≤ 80 years old, regardless of sex.
- •hospitalized patients diagnosed with acute coronary syndrome within 1 month.
- •at least one non-culprit lesion with diameter stenosis percentage of 30% to 70% by visual estimation on coronary angiography (CAG) after completing any planned percutaneous revascularization.
- •the lesion shown by OCT was lipid-rich plaque (Lipid pool arc > 90 °).
排除标准
- •Allergic to colchicine.
- •Colchicine was taken within 10 days before randomization.
- •Abnormal liver function (ALT > 3 times the upper limit of normal value).
- •Abnormal renal function (creatinine clearance rate < 45 ml/min).
- •Thrombocytopenia (PLT < 100G/L).
- •Uncontrolled infectious diseases during the screening period.
- •Known immune diseases or immune-related diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, malignant tumor and so on.
- •Pre-existing or plan for the administration of systemic anti-inflammatory treatments such as non-steroidal anti-inflammatory drugs, hormones, immunomodulatory and chemotherapeutic drugs.
- •History of surgery or interventional therapy within 6 months prior to the screening period.
- •A history of coronary artery bypass grafting or a plan for coronary artery bypass grafting within 1 year.
- •Left main coronary disease (≥50% reduction in lumen diameter by angiographic visual estimation).
- •Significant coronary calcification or tortuosity deemed to preclude OCT evaluation.
- •Diagnosed with mental disorders such as anxiety or depression.
- •Pregnant women, lactating women or women of childbearing age who do not use effective contraceptive methods.
- •Participated in other clinical trials within 3 months before the screening period.
- •Do not receive standardized treatment after being diagnosed with coronary heart disease.
- •The life expectancy of the subjects is less than 1 year.
- •The researchers determined that other conditions in which the patient was not suitable to participate in the clinical trial.
研究组 & 干预措施
Treatment Group
colchicine (0.5mg), one pill a day, oral intake
干预措施: Colchicine (Drug)
Control Group
placebo, one pill a day, oral intake
干预措施: Placebo (Drug)
结局指标
主要结局
changes of the Thickness of fibrous cap of coronary artery plaque
时间窗: 12 months
changes of the thickness of fibrous cap of coronary artery plaque measured by OCT
次要结局
- changes of the Macrophage accumulation in coronary artery plaque(12 months)
- changes of the inflammatory biomarkers (hsCRP, IL-6, and MPO)(12 months)
- changes of the Minimum lumen area (MLA)(12 months)
- major adverse cardiovascular and cerebrovascular events (MACCEs)(12 months)
- changes of the Average lipid arc of coronary artery plaque(12 months)
- changes of the Incidence of thin-cap fibroatheroma (TCFA)(12 months)
研究者
Xiang Cheng
professor, director
Wuhan Union Hospital, China