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
First author：Yongjun Wang
Corresponding author：Yongjun Wang
essential_information
- Person in charge：Yongjun Wang
- Data Sources： OTHERS
- Number of papers：OTHERS20230088
- Published time：2023-04-15
2023-04-15
Published articles
Journal：International Journal of Stroke
Publication type: Protocol
IF(IF): 6.948
PMID: 37060288 Link To Pubmed Full text Download
Background And Purpose
Anti-inflammatory therapy using colchicine has reduced recurrent vascular events in patients with coronary heart disease.
Method
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.
Conclusion
The CHANCE-3 trial will evaluate the efficacy and safety of colchicine for secondary prevention after stroke and TIA.
Main results
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.