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

Author:

Wang Yongjun12ORCID,Li Jiejie1ORCID,Johnston S Claiborne3,Hankey Graeme J45ORCID,Easton J Donald3ORCID,Meng Xia1,Shi Fu-Dong1,Wang Yilong1,Zhao Xingquan1ORCID,Li Zixiao1,Liu Liping1,Gu Hongqiu1ORCID,Jiang Yong1,Wang Anxin1ORCID,Pan Yuesong1ORCID,Jing Jing1ORCID,Niu Siying1,Li Hao1

Affiliation:

1. Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, and China National Clinical Research Center for Neurological Diseases, Beijing, China

2. Clinical Center for Precision Medicine in Stroke, Capital Medical University, Beijing, China

3. Department of Neurology, University of California, San Francisco, San Francisco, CA, USA

4. Medical School, The University of Western Australia, Perth, WA, Australia

5. Perron Institute for Neurological and Translational Science, Perth, WA, Australia

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.

Funder

Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences

the Capital's Funds for Health Improvement and Research

National Natural Science Foundation of China

National Key R&D Program of China

Publisher

SAGE Publications

Subject

Neurology,Neurology (clinical)

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