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
{"title":"Tenecteplase在视网膜中央动脉闭塞研究（TenCRAOS）：一项随机对照试验方案。","authors":"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","doi":"10.1177/23969873251344199","DOIUrl":null,"url":null,"abstract":"<p><strong>Rationale: </strong>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.</p><p><strong>Methods and design: </strong>TenCRAOS is an investigator-initiated, international, multicenter, randomized controlled, double-dummy, double-blind, phase <i>III</i> 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.</p><p><strong>Sample size: </strong>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.</p><p><strong>Outcomes: </strong>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.</p><p><strong>Discussion: </strong>TenCRAOS intends to assess the efficacy and safety of systemic TNK within 4.5 h of CRAO onset.</p>","PeriodicalId":46821,"journal":{"name":"European Stroke Journal","volume":" ","pages":"23969873251344199"},"PeriodicalIF":4.5000,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12165955/pdf/","citationCount":"0","resultStr":"{\"title\":\"Tenecteplase in Central Retinal Artery Occlusion Study (TenCRAOS): Protocol for a randomized-controlled trial.\",\"authors\":\"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\",\"doi\":\"10.1177/23969873251344199\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Rationale: </strong>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.</p><p><strong>Methods and design: </strong>TenCRAOS is an investigator-initiated, international, multicenter, randomized controlled, double-dummy, double-blind, phase <i>III</i> 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.</p><p><strong>Sample size: </strong>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.</p><p><strong>Outcomes: </strong>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. 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Tenecteplase in Central Retinal Artery Occlusion Study (TenCRAOS): Protocol for a randomized-controlled trial.
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.
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.
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