目的:评估秋水仙碱与安慰剂在降低症状发作前3个月内高风险非心源性缺血性卒中或短暂性脑缺血发作后后续卒中风险的有效性和安全性(CHANCE-3)。
方法:多中心,双盲,随机化,安慰剂对照试验。
方法:2022年8月11日至2023年4月13日期间,中国有244家医院。
方法:8343例年龄在40岁或以上的轻度至中度缺血性卒中或短暂性脑缺血发作且高敏C反应蛋白≥2mg/L的患者被纳入研究。
方法:患者在症状发作24小时内按1:1随机分配接受秋水仙碱(0.5mg,每天两次,第1-3天,然后每天0.5mg)或安慰剂90天。
方法:主要疗效结果是随机分组后90天内的任何新卒中。主要安全性结果是治疗期间的任何严重不良事件。所有疗效和安全性分析均按治疗意向进行。
结果:4176例患者被分配到秋水仙碱组,4167例被分配到安慰剂组。秋水仙碱组264例患者(6.3%)和安慰剂组270例患者(6.5%)在90天内发生卒中(风险比0.98(95%置信区间0.83~1.16);P=0.79)。秋水仙碱组91例(2.2%)患者和安慰剂组88例(2.1%)患者出现严重不良事件(P=0.83)。
结论:该研究没有提供证据表明,与安慰剂相比,低剂量秋水仙碱可以降低急性非心源性轻度至中度缺血性中风或短暂性脑缺血发作且高敏C反应蛋白≥2mg/L的患者在90天内发生卒中的风险。
背景:ClinicalTrials.gov,NCT05439356.
To assess the efficacy and safety of
colchicine versus placebo on reducing the risk of subsequent stroke after high risk non-cardioembolic ischaemic stroke or transient ischaemic attack within the first three months of symptom onset (CHANCE-3).
Multicentre, double blind, randomised, placebo controlled trial.
244 hospitals in China between 11 August 2022 and 13 April 2023.
8343 patients aged 40 years of age or older with a minor-to-moderate ischaemic stroke or transient ischaemic attack and a high sensitivity C-reactive protein ≥2 mg/L were enrolled.
Patients were randomly assigned 1:1 within 24 h of symptom onset to receive
colchicine (0.5 mg twice daily on days 1-3, followed by 0.5 mg daily thereafter) or placebo for 90 days.
The primary efficacy outcome was any new stroke within 90 days after randomisation. The primary safety outcome was any serious adverse event during the treatment period. All efficacy and safety analyses were by intention to treat.
4176 patients were assigned to the
colchicine group and 4167 were assigned to the placebo group. Stroke occurred within 90 days in 264 patients (6.3%) in the
colchicine group and 270 patients (6.5%) in the placebo group (hazard ratio 0.98 (95% confidence interval 0.83 to 1.16); P=0.79). Any serious adverse event was observed in 91 (2.2%) patients in the
colchicine group and 88 (2.1%) in the placebo group (P=0.83).
The study did not provide evidence that low-dose colchicine could reduce the risk of subsequent stroke within 90 days as compared with placebo among patients with acute non-cardioembolic minor-to-moderate ischaemic stroke or transient ischaemic attack and a high sensitivity C-reactive protein ≥2 mg/L.
ClinicalTrials.gov, NCT05439356.