NCT00754819已完成2 期
Colchicine Compared With Placebo to Reduce Hs-CRP in Patients With Acute Coronary Syndromes- Targeting Inflammation in Atherosclerosis Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To determine the effect of low dose colchicine on hs-CRP.
研究概览
简要总结
The purpose of this study is to evaluate the effect of colchicine on high sensitivity C-reactive protein (hs-CRP), a blood marker to measure inflammation, in patients with acute coronary syndromes.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with a diagnosis of acute coronary syndrome who are > 18 years old and who do not have any contraindication to colchicine.
排除标准
- •Contraindication to colchicine including any of the following:
- •hypersensitivity to colchicine
- •severe renal, hepatic or gastrointestinal disorder
- •blood dyscrasias (myelodysplasia cytopenias etc)
- •Concurrent use of moderate-strong CYP3A4 inhibitors (a complete list is appended in the full protocol)
- •Known severe liver disease and/or elevated transaminases > 1.5x the upper limit of normal
- •Estimated GFR < 50 ml/min
- •Pregnant or lactating women or women not protected by a reliable contraception method
- •Current treatment with colchicine at enrollment
- •Active infection or systemic inflammation eg active rheumatoid arthritis
研究组 & 干预措施
1
Active Comparator
Colchicine 1mg daily oral
干预措施: Colchicine (Drug)
2
Placebo Comparator
Placebo 1 capsule daily oral
干预措施: Placebo (Drug)
结局指标
主要结局
To determine the effect of low dose colchicine on hs-CRP.
时间窗: 30 days
次要结局
- To determine the effect of colchicine on (a)platelet function and (b)short-term risk (30 days) of cardiovascular events(30 days)
研究者
研究点 (1)
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