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