Individuals with minor ischaemic stroke and intracranial occlusion are at increased risk of poor outcomes. Intravenous thrombolysis with tenecteplase might improve outcomes in this population. We aimed to test the superiority of intravenous tenecteplase over non-thrombolytic standard of care in patients with minor ischaemic stroke and intracranial occlusion or focal perfusion abnormality. In this multicentre, prospective, parallel group, open label with blinded outcome assessment, randomised controlled trial, adult patients (aged ≥18 years) were included at 48 hospitals in Australia, Austria, Brazil, Canada, Finland, Ireland, New Zealand, Singapore, Spain, and the UK. Eligible patients with minor acute ischaemic stroke (National Institutes of Health Stroke Scale score 0–5) and intracranial occlusion or focal perfusion abnormality were enrolled within 12 h from stroke onset. Participants were randomly assigned (1:1), using a minimal sufficient balance algorithm to intravenous tenecteplase (0·25 mg/kg) or non-thrombolytic standard of care (control). Primary outcome was a return to baseline functioning on pre-morbid modified Rankin Scale score in the intention-to-treat (ITT) population (all patients randomly assigned to a treatment group and who did not withdraw consent to participate) assessed at 90 days. Safety outcomes were reported in the ITT population and included symptomatic intracranial haemorrhage and death. This trial is registered with , , and is closed to accrual. The trial was stopped early for futility. Between April 27, 2015, and Jan 19, 2024, 886 patients were enrolled; 369 (42%) were female and 517 (58%) were male. 454 (51%) were assigned to control and 432 (49%) to intravenous tenecteplase. The primary outcome occurred in 338 (75%) of 452 patients in the control group and 309 (72%) of 432 in the tenecteplase group (risk ratio [RR] 0·96, 95% CI 0·88–1·04, p=0·29). More patients died in the tenecteplase group (20 deaths [5%]) than in the control group (five deaths [1%]; adjusted hazard ratio 3·8; 95% CI 1·4–10·2, p=0·0085). There were eight (2%) symptomatic intracranial haemorrhages in the tenecteplase group versus two (<1%) in the control group (RR 4·2; 95% CI 0·9–19·7, p=0·059). There was no benefit and possible harm from treatment with intravenous tenecteplase. Patients with minor stroke and intracranial occlusion should not be routinely treated with intravenous thrombolysis. Heart and Stroke Foundation of Canada, Canadian Institutes of Health Research, and the British Heart Foundation.

中文翻译：

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替奈普酶与经证实闭塞的轻微缺血性中风的标准治疗 (TEMPO-2)：一项随机、开放标签、3 期优效性试验


患有轻微缺血性中风和颅内闭塞的个体出现不良结果的风险增加。替奈普酶静脉溶栓可能会改善该人群的预后。我们的目的是测试对于轻度缺血性卒中和颅内闭塞或局灶性灌注异常的患者，静脉注射替奈普酶相对于非溶栓标准治疗的优越性。在这项多中心、前瞻性、平行组、开放标签、盲法结果评估、随机对照试验中，纳入了澳大利亚、奥地利、巴西、加拿大、芬兰、爱尔兰、新西兰、新加坡 48 家医院的成年患者（年龄≥18 岁） 、西班牙和英国。符合条件的轻度急性缺血性卒中（美国国立卫生研究院卒中量表评分 0-5）和颅内闭塞或局灶性灌注异常的患者在卒中发病后 12 小时内入组。参与者被随机分配（1:1），使用最小足够平衡算法静脉注射替奈普酶（0·25 mg/kg）或非溶栓标准护理（对照）。主要结局是在 90 天评估的意向治疗 (ITT) 人群（随机分配到治疗组且未撤回参与同意的所有患者）中，病前改良 Rankin 量表评分恢复到基线功能。在 ITT 人群中报告了安全性结果，包括有症状的颅内出血和死亡。该试验已在 、 、 登记，并且已停止计提。审判因徒劳而提前停止。 2015年4月27日至2024年1月19日期间，共有886名患者入组； 369 名（42%）为女性，517 名（58%）为男性。 454 名（51%）被分配为对照组，432 名（49%）被分配为静脉注射替奈普酶。 主要结局发生在对照组 452 名患者中的 338 名患者 (75%) 和替奈普酶组 432 名患者中的 309 名患者 (72%)（风险比 [RR] 0·96，95% CI 0·88–1·04， p=0·29）。替奈普酶组死亡的患者数量（20 例死亡 [5%]）多于对照组（5 例死亡 [1%]；调整后的风险比 3·8；95% CI 1·4–10·2，p=0· 0085）。替奈普酶组中有 8 例 (2%) 出现症状性颅内出血，而对照组有 2 例 (<1%)（RR 4·2；95% CI 0·9–19·7，p=0·059）。静脉注射替奈普酶治疗没有任何益处，也可能有危害。轻微脑卒中和颅内闭塞患者不宜常规接受静脉溶栓治疗。加拿大心脏和中风基金会、加拿大健康研究所和英国心脏基金会。