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.

Abstract

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) (ABCD2 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.

TRIAL REGISTRY NAME:

Colchicine in High-risk Patients with Acute Minor-to-moderate Ischemic Stroke or Transient Ischemic Attack (CHANCE-3); URL: https://clinicaltrials.gov/ct2/show/NCT05439356?cond=CHANCE-3&draw=2&rank=1; Registration number: NCT05439356.

• Authors: Yongjun Wang, Jiejie Li, S Claiborne Johnston, Graeme J Hankey, J Donald Easton, Xia Meng, Fu-Dong Shi, Yilong Wang, Xingquan Zhao, Zixiao Li, Liping Liu, Hongqiu Gu, Yong Jiang, Anxin Wang, Yuesong Pan, Jing Jing, Siying Niu, Hao Li
• Journal: International journal of stroke : official journal of the International Stroke Society (Int J Stroke) Vol. 18 Issue 7 Pg. 873-878 (08 2023) ISSN: 1747-4949 [Electronic] United States
• PMID: 37060288 (Publication Type: Randomized Controlled Trial, Multicenter Study, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Platelet Aggregation Inhibitors
• Aspirin
• Clopidogrel
• Colchicine

Topics

• Humans
• Ischemic Attack, Transient (drug therapy)
• Stroke (drug therapy, chemically induced)
• Platelet Aggregation Inhibitors (therapeutic use)
• Aspirin (therapeutic use)
• Ischemic Stroke (drug therapy)
• Clopidogrel (therapeutic use)
• Colchicine (therapeutic use)