Colchicine Use for Primary Prevention in People at High Risk of Coronary Artery Disease
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 6,792
- 试验地点
- 1
- 主要终点
- The incidence of CAD
研究概览
简要总结
Colchicine has been widely used as an anti-gout medicine in the past decades. Some recent clinical trials have proved that low-dose colchicine can be used as a secondary prevention drug for coronary artery disease because of its anti-inflammatory mechanism. However, the effect on primary prevention has not been observed sufficiently. The objective of this study is to determine whether colchicine reduces the incidence of CAD in patients and its safety for long-term use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females who have at least 3 risk factors for CAD.
- •GFR>90mmol/L. 3 People are within 40-70 years old.
- •Patients are not pre-diagnosed with CAD, which is defined by negative results of CT coronary angiography.
排除标准
- •Patients with any pre-existing diagnosis of coronary artery disease.2.Other cardiovascular diseases such as peripheral vascular disease, congestive heart failure and cardiomyopathy.3.Cerebrovascular diseases such as cerebral thrombosis and cerebral hemorrhage. 4.Currently on treatment with colchicine.5.Patients who are known to be allergic to colchicine.6 Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %), documented before recruitment.7.Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.8.Any other non cardiovascular diseases, such as active malignancy requiring treatment at the time of screening or with a life expectancy of fewer than two years based on the investigator´s clinical judgment.
研究组 & 干预措施
Intervention Group
colchicine 0.5mg every 24 hours for 3 years
干预措施: Colchicine (Drug)
Control Group
1 placebo tablet every 24 hours for 3 years
干预措施: Placebo (Drug)
结局指标
主要结局
The incidence of CAD
时间窗: 3 years
Collect the incidence of CAD during the follow-up time. CAD is defined with the positive stress test, ST depression in ECG with typical symptoms of myocardial ischemia, and progression to myocardial infarction. To further detect patients with occult CAD, the rest of the asymptomatic patients will be subjected to CT coronary angiography, in which CAD is defined with over 50% diameter stenosis in a major coronary artery.
Occurrence of adverse events in both groups
时间窗: 3 years
Collect the occurrence of adverse events in both groups during the drug use.Adverse events include gastrointestinal, liver, hematology, muscle, neurology, other sensory, infectious and death.
次要结局
- MACE events(3 years)