Anti-inflammatory therapy with long-term colchicine prevented vascular recurrence in coronary disease. Unlike coronary disease, which is typically caused by atherosclerosis, ischaemic stroke is caused by diverse mechanisms including atherosclerosis and small vessel disease or is frequently due to an unknown cause. We aimed to investigate the hypothesis that long-term colchicine would reduce recurrent events after ischaemic stroke. We did a randomised, parallel-group, open-label, blinded endpoint assessed trial comparing long-term colchicine (0·5 mg orally per day) plus guideline-based usual care with usual care only. Hospital-based patients with non-severe, non-cardioembolic ischaemic stroke or high-risk transient ischaemic attack were eligible. The primary endpoint was a composite of first fatal or non-fatal recurrent ischaemic stroke, myocardial infarction, cardiac arrest, or hospitalisation (defined as an admission to an inpatient unit or a visit to an emergency department that resulted in at least a 24 h stay [or a change in calendar date if the hospital admission or discharge times were not available]) for unstable angina. The p value for significance was 0·048 to adjust for two prespecified interim analyses conducted by the data monitoring committee, for which the steering committee and trial investigators remained blinded. The trial was registered at () and is completed. 3154 patients were randomly assigned between Dec 19, 2016, and Nov 21, 2022, with the last follow-up on Jan 31, 2024. The trial finished before the anticipated number of outcomes was accrued (367 outcomes planned) due to budget constraints attributable to the COVID-19 pandemic. Ten patients withdrew consent for analysis of their data, leaving 3144 patients in the intention-to-treat analysis: 1569 (colchicine and usual care) and 1575 (usual care alone). A primary endpoint occurred in 338 patients, 153 (9·8%) of 1569 patients allocated to colchicine and usual care and 185 (11·7%) of 1575 patients allocated to usual care alone (incidence rates 3·32 3·92 per 100 person-years, hazard ratio 0·84; 95% CI 0·68–1·05, p=0·12). Although no between-group difference in C-reactive protein (CRP) was observed at baseline, patients treated with colchicine had lower CRP at 28 days and at 1, 2, and 3 years (p<0·05 for all timepoints). The rates of serious adverse events were similar in both groups. Although no statistically significant benefit was observed on the primary intention-to-treat analysis, the findings provide new evidence supporting the rationale for anti-inflammatory therapy in further randomised trials. Health Research Board Ireland, Deutsche Forschungsgemeinschaft (German Research Foundation), and Fonds Wetenschappelijk Onderzoek Vlaanderen (Research Foundation Flanders), Belgium.

中文翻译：

---

长期秋水仙碱预防非心源性卒中血管复发事件（CONVINCE）：一项随机对照试验


长期秋水仙碱抗炎治疗可预防冠心病血管复发。与通常由动脉粥样硬化引起的冠状动脉疾病不同，缺血性中风是由多种机制引起的，包括动脉粥样硬化和小血管疾病，或者通常是由于未知原因引起的。我们的目的是研究长期服用秋水仙碱会减少缺血性中风后复发事件的假设。我们进行了一项随机、平行组、开放标签、盲态终点评估试验，比较长期秋水仙碱（每天口服 0·5 mg）加基于指南的常规护理与仅常规护理。患有非严重、非心源性缺血性中风或高风险短暂性脑缺血发作的医院患者符合资格。主要终点是首次致命性或非致命性复发性缺血性中风、心肌梗塞、心脏骤停或住院治疗（定义为入住住院病房或前往急诊室并住院至少 24 小时）的复合终点[或者如果无法确定入院或出院时间，则更改日历日期]）不稳定型心绞痛。显着性 p 值为 0·048，以调整数据监测委员会进行的两项预先指定的中期分析，指导委员会和试验研究者对此保持盲态。试验已在 () 注册并已完成。 2016年12月19日至2022年11月21日期间，3154名患者被随机分配，最后一次随访时间为2024年1月31日。由于预算限制，试验在预期结果数量（计划的367个结果）产生之前完成。应对新冠肺炎 (COVID-19) 大流行。 10 名患者撤回同意对其数据进行分析，从而使 3144 名患者进入意向治疗分析：1569 名（秋水仙碱和常规护理）和 1575 名（仅常规护理）。主要终点发生在 338 名患者中，其中 1569 名患者中的 153 名 (9·8%) 被分配到秋水仙碱和常规护理，1575 名患者中的 185 名 (11·7%) 被分配到单独常规护理（每组的发病率为 3·32 3·92） 100 人年，风险比 0·84；95% CI 0·68–1·05，p=0·12)。尽管在基线时未观察到 C 反应蛋白 (CRP) 的组间差异，但接受秋水仙碱治疗的患者在第 28 天以及第 1、2 和 3 年时的 CRP 较低（所有时间点 p<0·05）。两组的严重不良事件发生率相似。尽管在主要意向治疗分析中没有观察到统计学上显着的益处，但研究结果提供了新的证据，支持进一步随机试验中抗炎治疗的基本原理。爱尔兰健康研究委员会、Deutsche Forschungsgemeinschaft（德国研究基金会）和比利时 Fonds Wetenschappelijk Onderzoek Vlaanderen（佛兰德斯研究基金会）。