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

Background: Anti-inflammatory therapy using colchicine has reduced recurrent vascular events in patients with coronary heart disease. Design: 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 transient ischemic attack (TIA) (ABCD(2) score >= 4) and a high-sensitivity CRP (hsCRP) level of >= 2 mg/L will be randomly assigned within 24 h 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. 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.

Automated summary

The CHANCE-3 study is a randomized, double-blind, placebo-controlled multicenter trial that aims to investigate the efficacy of colchicine therapy in patients with acute minor-to-moderate ischemic stroke or transient ischemic attack. The study will randomly assign 8,238 patients with high-sensitivity CRP level of >= 2 mg/L to receive colchicine or placebo, in addition to optimal medical therapy. The primary outcome is the occurrence of any stroke within 3 months of randomization, with a goal of detecting a 25% reduction in the colchicine group.