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Clinical Trial Summary

Edoxaban (also referred to as Lixiana) is an anti-clotting drug, approved by Health Canada for the prevention of stroke in patients with atrial fibrillation (abnormal heart rhythm). This study is being done to try to determine the best time to start apixaban treatment after an ischemic stroke has occurred.

The purpose of the LASER study is to determine the safety of early edoxaban use after TIA/ischemic stroke in patients with atrial fibrillation using advanced MR imaging. This study will also gather information about participant general well being, mental status, and the effects of the TIA/stroke on daily living, as well as CT and MRI of the brain.

Clinical Trial Description

The primary aim of the Lixiana Acute Stroke Evaluation Registry is to demonstrate the safety of edoxaban initiation within 5 days of cardioembolic stroke. Safety will be established by demonstrating low rates of hemorrhage in this setting. The secondary aim is to identify clinical, imaging and RNA transcript predictors of hemorrhagic transformation after cardioembolic stroke.

The Investigators hypothesize that initiation of edoxaban within 5 days of stroke/TIA will not be associated with increased symptomatic HT rates, relative to patients in whom anticoagulation is delayed. The Investigators further hypothesize that early edoxaban initiation will be associated with a lower rate of recurrent ischemic stroke than those in whom it is delayed. The Investigators also hypothesize that RNA expressed in leukocytes at time of stroke can stratify risk of HT in patients treated with edoxaban.

The Lixiana Acute Stroke Evaluation Registry (LASER) is a randomized controlled trial with an associated registry. Patients with previously known or newly diagnosed AF and acute ischemic stroke will be screened in the Emergency Departments or stroke units. A total of 150 male and female participants will be recruited. Informed consent will be obtained from the participant or substitute decision maker, in all cases prior to enrolment.

Participants will be randomized (2:1) to early (≤5 days; n=100) or delayed (6-14 days; n=50) edoxaban initiation. In participants randomized to early treatment, edoxaban will be initiated as soon as possible after the baseline MRI (maximum 24 hours). Participants will be treated with edoxaban (60 mg once daily). If the eGFR is ≤50 ml/min kg or body weight ≤60 kg, the edoxaban dose will be reduced to 30 mg once daily.

The primary endpoint is the rate of symptomatic hemorrhagic transformation (HT) defined as a parenchymal haemorrhage >1/3 the volume of the ischemic infarct (ECASS PH2) associated with clinical deterioration (worsening of NIHSS score of 4 or more points) within 30 days of treatment initiation. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03494530
Study type Observational
Source University of Alberta
Contact Ken Butcher, MD, PhD
Phone 780-248-1927
Status Recruiting
Start date November 4, 2018
Completion date December 31, 2020

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