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

Clopidogrel with aspirin in High-risk patients with Acute Non-disabling Cerebrovascular Events II (CHANCE-2): rationale and design of a multicentre randomised trial

第一作者:王拥军

通讯作者:王拥军

Minor Stroke

基本信息

  • 负责人:王拥军
  • 数据来源: CHANCE-2
  • 论文编号:CHANCE-220210063
  • 发表时间:2021-05-05

2021-05-05

已发表文章

发表杂志:Stroke and Vascular Neurology

发表类型: Study Protocol

影响因子(IF): 4.081

PMID: NA(待更新) Pubmed原文链接 全文下载

主要研究背景及目的

Background In patients with a minor ischaemic stroke or transient ischaemic attack (TIA), separate trials have shown that dual antiplatelet therapy with clopidogrel plus aspirin (clopidogrel–aspirin) or ticagrelor plus aspirin (ticagrelor–aspirin) are more effective than aspirin alone in stroke secondary prevention. However, these two sets of combination have not been directly compared. Since clopidogrel was less effective in stroke patients who were CYP2C19 loss-of-function (LOF) allele carriers, whether ticagrelor–aspirin is clinically superior to clopidogrel–aspirin in this subgroup of patients with stroke is unclear. Aim To describe the rationale and design considerations of the Clopidogrel in High-risk patients with Acute Non-disabling Cerebrovascular Events (CHANCE-2) trial.

方法

Design CHANCE-2 is a randomised, double-blind, double-dummy, placebo-controlled, multicentre trial that compares two dual antiplatelet strategies for minor stroke or TIA patients who are CYP2C19 LOF allele carriers: ticagrelor (180 mg loading dose on day 1 followed by 90 mg twice daily on days 2–90) or clopidogrel (300 mg loading dose on day 1 followed by 75 mg daily on days 2–90), plus open-label aspirin with a dose of 75–300 mg on day 1 followed by 75 mg daily on day 2–21. All will be followed for 1 year.

结论

Discussion The CHANCE-2 trial will evaluate whether ticagrelor–aspirin is superior to clopidogrel–aspirin for minor stroke or TIA patients who are CYP2C19 LOF allele carriers.

主要结果

Study outcomes The primary efficacy outcome is any stroke (ischaemic or haemorrhagic) within 3 months and the primary safety outcome is any severe or moderate bleeding event within 3 months.