Tenecteplase in Central Retinal Artery Occlusion Study (TenCRAOS): Protocol for a randomized-controlled trial.

IF 4.5 3区医学 Q1 CLINICAL NEUROLOGY

European Stroke Journal Pub Date : 2025-06-12 DOI:10.1177/23969873251344199

Stephen J Ryan, Øystein Kalsnes Jørstad, Mona Skjelland, Claus Z Simonsen, Toke Bek, Rolf Ankerlund Blauenfeldt, Petra Ijäs, Arja Laitinen, Andrej N Khanevski, Jørgen Krohn, Eyvind Rødahl, Robin Lemmens, Jelle Demeestere, Catherine Cassiman, Ingvild Nakstad, Kristin Evensen, Tiril Sandell, Steffen Hamann, Louisa M Christensen, Sverre Rosenbaum, Vaidas Matijosaitis, Reda Zemaitiene, Hanne Ellekjær, Dordi Austeng, Thomas C Truelsen, Michael V Mazya, Frank Träisk, Pauli Ylikotila, Ulpu Salmi, Kristian N Jenssen, Håvard Lisether, Cathrine Breivik, Kristina Devik, Lasse-Marius Sandes Honningsvåg, Jurgita Valaikienė, Andrius Cimbalas, Vetle Nilsen Malmberg, Espen Anderson, Sylvie De Raedt, Marcel Ten Tusscher, Noémie Ligot, Deborah Lipski, Fredrik Björck, Annelie Hamrin, Tore Solbakken, Ane Roushan Tharaldsen, Anette Huuse Farmen, Andreas Helgesen, Stein Harald Johnsen, Geir Bertelsen, Åse Hagen Morsund, Erik Holen, Arnstein Tveiten, Henrik B Johannessen, Peter Kelly, Evelyn O'Neill, Ansar Roy, Christina Kefaloykos, Thor Håkon Skattør, Kristian L Kraglund, Lauren Sanders, Peter Vanacker, Daniel Strbian, Morten C Moe, Anne Hege Aamodt

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引用次数: 0

Abstract

Rationale: Central retinal artery occlusion (CRAO) is an ophthalmologic emergency that, without prompt reperfusion, is associated with a high risk of permanent blindness. There is currently no evidence-based, effective treatment for CRAO.

Methods and design: TenCRAOS is an investigator-initiated, international, multicenter, randomized controlled, double-dummy, double-blind, phase III trial testing tenecteplase (TNK) 0.25 mg/kg + placebo versus acetylsalicylic acid (ASA) 300 mg + placebo. The target population is patients diagnosed with CRAO and a best-corrected visual acuity (BCVA) of ⩾1.0 logarithm of the minimum angle of resolution (logMAR), corresponding to a decimal BCVA of ⩽0.1 or a fraction BCVA of ⩽6/60, who can be treated within 4.5 h.

Sample size: Assuming a difference in proportion of participants reaching the primary endpoint of 20% in the placebo/ASA treatment group versus 50% in the TNK/placebo group, we need 78 participants to reach 80% power to detect the difference on a 5% significance level.

Outcomes: The primary outcome is the proportion of participants with BCVA of ⩽0.7 logMAR in the affected eye at 30-day follow-up, corresponding to a decimal BCVA of ⩾0.2 or fraction BCVA of ⩾6/30, representing a clinically relevant improvement of BCVA of ⩾0.3 logMAR (or 15 letters). Secondary efficacy outcomes include proportion of participants with BCVA of ⩽0.5 logMAR, corresponding to a decimal BCVA of ⩾0.32 or fraction BCVA of ⩾ 6/19, self-reported vision-targeted health status, quality of life, and modified Rankin Score at 30 and 90 days. Safety outcomes include symptomatic intracranial hemorrhage, major bleeding, and mortality. Exploratory analyses include assessment with optical coherence tomography with angiography and transorbital ultrasound.

Discussion: TenCRAOS intends to assess the efficacy and safety of systemic TNK within 4.5 h of CRAO onset.

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Tenecteplase在视网膜中央动脉闭塞研究（TenCRAOS）：一项随机对照试验方案。

理由：视网膜中央动脉闭塞（CRAO）是一种眼科急症，如果没有及时的再灌注，会导致永久性失明的高风险。目前尚无针对CRAO的循证有效治疗方法。方法和设计：TenCRAOS是一项由研究者发起、国际多中心、随机对照、双虚拟、双盲的III期试验，测试tenecteplase (TNK) 0.25 mg/kg +安慰剂与乙酰水杨酸（ASA） 300 mg +安慰剂的对比。目标人群是诊断为CRAO和最小分辨角（logMAR）的小于1.0对数的最佳矫正视力（BCVA）的患者，对应于小数BCVA≤0.1或分数BCVA≤6/60，可以在4.5 h内治疗。样本量：假设安慰剂/ASA治疗组达到主要终点的参与者比例为20%，而TNK/安慰剂组为50%，我们需要78名参与者达到80%的功率才能在5%的显著性水平上检测到差异。结果：主要结果是在30天随访中受影响的眼睛中BCVA为0.7 logMAR的参与者的比例，对应于小于或等于或等于或大于或等于6/30的小数BCVA，代表小于或等于或等于或等于或大于或等于或等于15个字母的BCVA的临床相关改善。次要疗效结果包括BCVA≥0.5 logMAR的参与者比例，对应于小于或等于0.32的十进制BCVA或小于或等于6/19的分数BCVA，自我报告的视力目标健康状况，生活质量，以及30天和90天修改的Rankin评分。安全性结果包括症状性颅内出血、大出血和死亡率。探索性分析包括光学相干断层扫描血管造影和经眶超声评估。讨论：TenCRAOS计划在CRAO发病后4.5小时内评估系统性TNK的有效性和安全性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Stroke Journal Multiple-

CiteScore

7.50

自引率

6.60%

发文量

102

期刊介绍： Launched in 2016 the European Stroke Journal (ESJ) is the official journal of the European Stroke Organisation (ESO), a professional non-profit organization with over 1,400 individual members, and affiliations to numerous related national and international societies. ESJ covers clinical stroke research from all fields, including clinical trials, epidemiology, primary and secondary prevention, diagnosis, acute and post-acute management, guidelines, translation of experimental findings into clinical practice, rehabilitation, organisation of stroke care, and societal impact. It is open to authors from all relevant medical and health professions. Article types include review articles, original research, protocols, guidelines, editorials and letters to the Editor. Through ESJ, authors and researchers have gained a new platform for the rapid and professional publication of peer reviewed scientific material of the highest standards; publication in ESJ is highly competitive. The journal and its editorial team has developed excellent cooperation with sister organisations such as the World Stroke Organisation and the International Journal of Stroke, and the American Heart Organization/American Stroke Association and the journal Stroke. ESJ is fully peer-reviewed and is a member of the Committee on Publication Ethics (COPE). Issues are published 4 times a year (March, June, September and December) and articles are published OnlineFirst prior to issue publication.