Low-dose Colchicine for CABG Graft Failure Prevention: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 622
- 试验地点
- 1
- 主要终点
- graft failure rate
研究概览
简要总结
This study aims to evaluate whether daily low-dose colchicine (0.5 mg), administered in addition to the standard secondary prevention regimen recommended in clinical guidelines after coronary artery bypass grafting (CABG), can further prevent graft failure after CABG through a prospective, randomized, double-blind, placebo-controlled clinical trial.
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
- •Be male or female, aged 18 years or older;
- •Within 3 days after successful isolated coronary artery bypass grafting (CABG);
- •Sign informed consent;
排除标准
- •Severe valvular heart disease requiring concomitant or staged valvular surgery;
- •History of non-skin cancer in the past 3 years;
- •Inflammatory bowel disease or chronic diarrhea;
- •Neuromuscular diseases or non-transient creatine kinase levels greater than 3 times the upper limit of the normal range (except those associated with myocardial infarction);
- •Clinically significant non-transient (At least 2 laboratory tests) blood abnormalities (Hemoglobin <100g/L or hematocrit < 30% or > 52% or white blood cell count < 3×109/L or platelet count < 100×109/L);
- •Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² (based on the CKDEPI formula);
- •Serum alanine aminotransferase and/or aspartate aminotransferase levels greater than 2 times the upper limit of the normal range, accompanied by serum total bilirubin levels greater than 2 times the upper limit of the normal range or severe liver disease with coagulation disorders (INR>1.5) (except for elevated glutamic oxalacetic transaminase associated with myocardial infarction);
- •Decline in cognitive function due to inability to perform basic activities of daily living independently;
- •Drug or alcohol abuse;
- •Other immunosuppressive therapies already in existence or planned;
- •Other causes require long-term colchicine treatment;
- •History of clear or suspected colchicine allergy;
- •Strong CYP3A4 or P-glycoprotein inhibitors (such as cyclosporine, antiretrovirals, antifungals, erythromycin and clarithromycin) have been used and no other alternative drugs can be used.
研究组 & 干预措施
Colchicine group
Patients are randomized within 3 days after successful isolated CABG, and on the day of randomization, eligible patients receive guideline-directed standard secondary prevention therapy plus colchicine (0.5 mg qd) starting as soon as possible (within 24 hours) and continuing for 24 months.
干预措施: Colchicine Pill (Drug)
Placebo group
Patients are randomized within 3 days after successful isolated CABG, and on the day of randomization, eligible patients receive guideline-directed standard secondary prevention therapy plus matching placebo (1 tablet qd) starting as soon as possible (within 24 hours) and continuing for 24 months.
干预措施: Placebo (Drug)
结局指标
主要结局
graft failure rate
时间窗: 2 year after randomization
At 24 months postoperatively, all patients who complete the study will undergo coronary computed tomographic angiography (CCTA) to assess graft patency, calculated as 1 minus graft failure rate, where graft failure rate = (number of grafts graded B or O according to the Fitzgibbon classification / total number of grafts) × 100%.
次要结局
- MACCE(2 year after randomization)
研究者
Liu Xiaoli
Professor
Beijing Anzhen Hospital