Lixiana Acute Stroke Evaluation Registry

Summary

Study Design: Lixiana Acute Stroke Evaluation Registry (LASER) is a randomized controlled trial with an associated registry. Patients with previously known or newly diagnosed atrial fibrillation (AF) and acute ischemic stroke within five days will be randomized 2:1 to early (≤ 5 days) or delayed (6-14 days) edoxaban initiation. Ischemic stroke will be defined as evidence of acute focal cerebral infarction confirmed on CT/MRI and/or focal hypoperfusion/vessel occlusion on multimodal CT, or by sudden focal and objective neurological deficits (i.e NIHSS ≥ 1) of presumed ischemic origin persisting \> 24 hours. Study Aim and Objectives: The primary aim of LASER is to demonstrate the safety of edoxaban initiation within five days of cardioembolic stroke. Secondary aim is to determine predictors of hemorrhagic transformation (HT) after cardioembolic stroke. Investigators will systematically assess prospectively collected Computed Tomography (CT) scan images for evidence of HT and re-infarction.

Timeline

Start

2018-06-01

Primary completion

2021-12-01

Completion

2021-12-01

Publications

• Alrohimi A, Jickling G, Jeerakathil T, Shuaib A, Khan K, Kate M, Hill MD, Buck B, Butcher K. Protocol for LASER: A Randomized Evaluation and an Associated Registry of Early Anticoagulation With Edoxaban After Ischemic Stroke in Patients With Atrial Fibrillation. Front Neurol. 2021 Mar 31;12:645822. doi: 10.3389/fneur.2021.645822. eCollection 2021.

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Indications