A1 Refereed original research article in a scientific journal
Tenecteplase in Central Retinal Artery Occlusion Study (TenCRAOS): Protocol for a randomized-controlled trial
Authors: Ryan, Stephen J.; Jorstad, Oystein Kalsnes; Skjelland, Mona; Simonsen, Claus Z.; Bek, Toke; Blauenfeldt, Rolf Ankerlund; Ijas, Petra; Laitinen, Arja; Khanevski, Andrej N.; Krohn, Jorgen; Rodahl, Eyvind; Lemmens, Robin; Demeestere, Jelle; Cassiman, Catherine; Nakstad, Ingvild; Evensen, Kristin; Sandell, Tiril; Hamann, Steffen; Christensen, Louisa M.; Rosenbaum, Sverre; Matijosaitis, Vaidas; Zemaitiene, Reda; Ellekjaer, Hanne; Austeng, Dordi; Truelsen, Thomas C.; Mazya, Michael, V; Traisk, Frank; Ylikotila, Pauli; Salmi, Ulpu; Jenssen, Kristian N.; Lisether, Havard; Breivik, Cathrine; Devik, Kristina; Honningsvag, Lasse-Marius Sandes; Valaikiene, Jurgita; Cimbalas, Andrius; Malmberg, Vetle Nilsen; Anderson, Espen; De Raedt, Sylvie; Tusscher, Marcel Ten; Ligot, Noemie; Lipski, Deborah; Bjorck, Fredrik; Hamrin, Annelie; Solbakken, Tore; Tharaldsen, Ane Roushan; Farmen, Anette Huuse; Helgesen, Andreas; Johnsen, Stein Harald; Bertelsen, Geir; Morsund, Ase Hagen; Holen, Erik; Tveiten, Arnstein; Johannessen, Henrik B.; Kelly, Peter; O'Neill, Evelyn; Roy, Ansar; Kefaloykos, Christina; Skattor, Thor Hakon; Kraglund, Kristian L.; Sanders, Lauren; Vanacker, Peter; Strbian, Daniel; Moe, Morten C.; Aamodt, Anne Hege; TenCRAOS Investigators
Publisher: SAGE PUBLICATIONS LTD
Publishing place: LONDON
Publication year: 2025
Journal: European Stroke Journal
Journal name in source: EUROPEAN STROKE JOURNAL
Journal acronym: EUR STROKE J
Number of pages: 9
ISSN: 2396-9873
eISSN: 2396-9881
DOI: https://doi.org/10.1177/23969873251344199
Web address : https://doi.org/10.1177/23969873251344199
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.
Funding information in the publication:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Oslo University Hospital is the trial sponsor. The main sources of funding are Klinbeforsk (National program for clinical treatment research in the specialist health service), the South-Eastern Norway Regional Health Authority, and Odd Fellow. Boehringer-Ingelheim provided tenecteplase and intravenous placebo free of charge as well as financial support to the sites outside Norway but had no influence on the study conduct, analysis, or interpretation. Boehringer-Ingelheim was given the opportunity to review the manuscript for medical and scientific consistency as it relates to Boehringer-Ingelheim substances, as well as intellectual property considerations.
