drugset / Trial / NCT03197194
A Phase III Randomized, Blind, Double Dummy, Multicenter Study Assessing the Efficacy and Safety of IV THrombolysis (Alteplase) in Patients With acutE Central retInal Artery Occlusion
RandomizedParallel-groupDouble-blindTreatment
Summary
The aim of the THEIA study is to determine if Alteplase administrated within 4.5 hours improve visual deficit due to acute CRAO with a good safety profile.
Timeline
- Start
- 2018-06-08
- Primary completion
- 2024-01-16
- Completion
- 2024-01-16
Outcome
Missed primary endpoint
paper Intravenous alteplase administered within 4·5 h of CRAO onset was not associated with a significant improvement in visual acuity compared with aspirin PMID 41109232 ↗
paper adjusted odds ratio 1·1 [95% CI 0·07 to 18·39]; p=0·95 PMID 41109232 ↗
Publications
- Preterre C, Gaultier A, Obadia M, Vignal C, Mourand I, Plat J, Sablot D, Gaudron M, Rodier G, Godeneche G, Urbanczyk C, Marc G, Massardier E, Adam S, Boulanger M, Marcel S, Mechtouff L, Ronziere T, Calviere L, Godard-Ducceschi S, Barbin L, Lebranchu P, Guillon B; THEIA collaborators. Intravenous alteplase versus oral aspirin for acute central retinal artery occlusion within 4.5 h of severe vision loss (THEIA): a multicentre, double-dummy, patient-blinded and assessor-blinded, randomised, controlled, phase 3 trial. Lancet Neurol. 2025 Nov;24(11):909-919. doi: 10.1016/S1474-4422(25)00308-4.
- Abdelmassih Y, Mauget-Faysse M, Seners P, Milea D, Hallali G, Guillaume J, Lecler A, Vignal C, Le Mer Y, Paques M, Bonnin S, Obadia M. Early reperfusion in patients with acute retinal artery occlusion: A multicenter prospective study. Int J Stroke. 2025 Mar;20(3):338-346. doi: 10.1177/17474930241306692. Epub 2024 Dec 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alteplase | Protein / enzyme biologic | 0.9 mg/kg | Intravenous |
| Comparator | Aspirin | Small molecule | 300 mg | Oral |