Neurology Division, Department of Internal Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada.
Departments of Neurosciences, Radiology and Community Health Sciences, University of Calgary, Calgary, AB, Canada.
Int J Stroke. 2024 Aug;19(7):817-822. doi: 10.1177/17474930241253702. Epub 2024 May 17.
Almost half of acute ischemic stroke patients present with mild symptoms and there are large practice variations in their treatment globally. Individuals with an intracranial occlusion who present with minor stroke are at an increased risk of early neurological deterioration and poor outcomes. Individual patient data meta-analysis in the subgroup of patients with minor deficits showed benefit of alteplase in improving outcomes; however, this benefit has not been seen with intravenous alteplase in published randomized trials.
TEMPO-2 (A Randomized Controlled Trial of Tenecteplase Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion) is a prospective, open label with blinded outcome assessment, randomized controlled trial, designed to test the superiority of intravenous tenecteplase (0.25 mg/kg) over nonthrombolytic standard of care, with an estimated sample size of 1274 patients. Adult patients presenting with acute ischemic stroke with the National Institutes of Health Stroke Scale (NIHSS) ⩽ 5 and visible arterial occlusion or perfusion deficit within 12 h of onset are randomized to receive either tenecteplase (0.25 mg/kg) or standard of care. The primary outcome is return to baseline neurological functioning, measured by the modified Rankin scale (mRS) at 90 days. Safety outcomes include death and symptomatic hemorrhage (intra or extra-cranial). Other secondary outcomes include mRS 0-1, mRS 0-2, ordinal shift analysis of the mRS, partial, and full recanalization on follow-up computed tomography angiogram.
Results of this trial will aid in determining whether there is benefit of using tenecteplase (0.25 mg/kg) in treating patients presenting with minor stroke who are at high risk of developing poor outcomes due to presence of an intracranial occlusion.
Data will be available upon reasonable request.
近半数急性缺血性脑卒中患者的症状轻微，而全球对其治疗的临床实践存在较大差异。颅内闭塞伴轻微脑卒中的患者有早期神经恶化和不良结局的风险增加。在有轻微缺损的亚组患者中进行的个体患者数据汇总分析显示，阿替普酶治疗可改善结局；然而，在已发表的随机试验中，静脉内阿替普酶治疗并未显示出获益。
TEMPO-2（替奈普酶与标准治疗对伴明确闭塞的轻微缺血性脑卒中的随机对照试验）是一项前瞻性、开放标签、盲法结局评估的随机对照试验，旨在检验静脉内替奈普酶（0.25mg/kg）优于非溶栓标准治疗的优越性，估计样本量为 1274 例患者。发病 12 小时内 NIHSS 评分≤5 分且存在动脉闭塞或灌注缺损的急性缺血性脑卒中成年患者，随机接受替奈普酶（0.25mg/kg）或标准治疗。主要结局是通过改良 Rankin 量表（mRS）在 90 天时恢复到基线神经功能，该量表评估了患者的功能恢复情况。安全性结局包括死亡和症状性出血（颅内或颅外）。其他次要结局包括 mRS 0-1、mRS 0-2、mRS 有序转移分析、部分和完全再通。
该试验的结果将有助于确定对于颅内闭塞的高危轻微脑卒中患者，使用替奈普酶（0.25mg/kg）治疗是否有益。
可根据合理要求提供数据。
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