国家神经系统疾病临床医学研究中心数据管理与共享系统
Data Management And Sharing System of China National Clinical Research Center for Neurological Diseases
Colchicine in High-risk Patients with Acute Minor-to-moderate Ischemic Stroke or Transient Ischemic Attack (CHANCE-3): Rationale and design of a multicenter randomized placebo-controlled trial
第一作者：Yongjun Wang
通讯作者：Yongjun Wang
基本信息
- 负责人：Yongjun Wang
- 数据来源： OTHERS
- 论文编号：OTHERS20230088
- 发表时间：2023-04-15
2023-04-15
已发表文章
主要研究背景及目的
Anti-inflammatory therapy using colchicine has reduced recurrent vascular events in patients with coronary heart disease.
方法
Colchicine in High-risk Patients with Acute Minor-to-moderate Ischemic Stroke or Transient Ischemic Attack (CHANCE-3) is a randomized, double-blind, placebo-controlled multicenter trial, in which 8,238 patients with acute minor-to-moderate ischemic stroke (NIHSS≤5) or high-risk TIA (ABCD2 score ≥ 4) and a hsCRP level of ≥2mg/L will be randomly assigned within 24 hours of symptom onset to colchicine (1 mg daily on days 1-3, followed by 0.5 mg daily for a total of 90 days) or matching placebo, on a background of optimal medical therapy.
结论
The CHANCE-3 trial will evaluate the efficacy and safety of colchicine for secondary prevention after stroke and TIA.
主要结果
The study will have 90% power to detect a 25% reduction in the primary efficacy outcome of any stroke within 3 months of randomization. Adverse events potentially related to the use of colchicine will also be analyzed. The primary analysis will be by intention-to-treat.