TENecteplase in Central Retinal Artery Occlusion Stuy (TenCRAOS)

Summary

TENecteplase in Central Retinal Artery Occlusion (TenCRAOS): A Prospective, randomized-controlled, double-dummy, double-blind phase 3 multi-centre trial of TNK 0.25 mg/kg + placebo vs. ASA + placebo (2 arms with 1:1 block randomization). A Prospective, randomized-controlled, double-dummy, double-blind phase 3 multi-centre trial of TNK 0.25 mg/kg + placebo vs. ASA + placebo (2 arms with 1:1 block randomization). At all participating centers, ophthalmologists are involved in the diagnosis and visual outcome measurements using a standardized protocol. The patients will be promptly examined by the ophthalmologist. As soon as the CRAO is diagnosed by the ophthalmologist, the patients will be managed in the stroke unit during treatment, monitoring, and medical investigations. After treatment in the stroke unit, the patients will be re-examined by an ophthalmologist and a neurologist as an out-patient at (30 ±5) and 90 (±15) days

Timeline

Start

2020-10-30

Primary completion

2025-06-20

Completion

2025-06-20

Publications

• Ryan SJ, Jorstad OK, Skjelland M, Pesonen M, Simonsen CZ, Bek T, Blauenfeldt RA, Ijas P, Laitinen A, Khanevski A, Krohn J, Rodahl E, Lemmens R, Demeestere J, Cassiman C, Nakstad I, Evensen K, Sandell T, Hamann S, Truelsen TC, Christensen LM, Rosenbaum S, Matijosaitis V, Zemaitiene R, Ellekjaer H, Almaas E, Austeng D, Mazya MV, Traisk F, Ylikotila P, Salmi U, Jenssen KN, Lisether H, Breivik C, Devik K, Honningsvag LE, Valaikiene J, Cimbalas A, Malmberg VN, Anderson E, Roy A, Skattor TH, Kraglund KL, Kefaloykos C, Olsen IC, Vanacker P, Strbian D, Moe MC, Aamodt AH; TenCRAOS Investigators. A Randomized Trial of Tenecteplase in Acute Central Retinal Artery Occlusion. N Engl J Med. 2026 Jan 29;394(5):442-450. doi: 10.1056/NEJMoa2508515.

Drugs

Indications