Colchicine for Acute Coronary Syndromes. A Multicenter Double Blind Randomized Trial.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Overall mortality, new acute coronary syndrome, and ischemic stroke.
研究概览
简要总结
Multicenter, double blind, randomized trial to assess the effect of low-dose colchicine (0.5mg/day) on overall mortality, new coronary syndromes, and ischemic stroke at 2 years after an acute coronary syndrome. The study hypothesis is that colchicine may reduce the specified combined endpoint from 16% to 7-8% at a 2-years follow-up.
详细描述
Multicenter, double-blind randomized trial to evaluate the efficacy of low dose colchicine (0.5mg once daily for 2 years) to reduce the incidence of subsequent overall mortality, new acute coronary syndromes, and ischemic stroke in patients admitted for an acute coronary syndrome.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18years
- •Acute coronary syndrome (unstable angina or acute myocardial infarction)
- •Life expectancy> 2 years
- •Absence of contraindications to colchicine
排除标准
- •Colchicine treatment for any cause
- •Severe liver disease
- •Renal insufficiency with creatinine>150mmol/l or creatinine clearance<30ml/min/1.73m2
- •Known cancer
- •Chronic inflammatory bowel disease
- •treatment with cyclosporine
- •allergy or hypersensitivity to colchicine
- •pregnancy or lactating woman or woman with childbearing potential without valid contraception
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
Colchicine
Colchicine 0.5mg once daily for 24 months
干预措施: Colchicine (Drug)
结局指标
主要结局
Overall mortality, new acute coronary syndrome, and ischemic stroke.
时间窗: 24 months
次要结局
- Mortality(24 months)
- New acute coronary syndrome (unstable angina and myocardial infarction)(24 months)
- Ischemic Stroke(24 months)
研究者
Massimo Imazio
MD
Maria Vittoria Hospital