← Back to Search

Anticoagulant

Edoxaban for Stroke in Atrial Fibrillation Patients (LASER Trial)

Phase 4
Recruiting
Led By Brian Buck, MD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ischemic stroke, diagnosed and enrolled ≤5 days from symptom onset (Ischemic stroke is defined as evidence of acute focal cerebral infarction confirmed on CT/MRI and/or focal hypoperfusion/vessel occlusion on multimodal imaging, or by sudden focal and objective neurological deficits (i.e NIHSS ≥ 1) of presumed ischemic origin persisting > 24 hours)
Male or female patients 18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 7 and 90 after edoxaban initiation
Awards & highlights

LASER Trial Summary

This trial will compare the safety of early vs delayed initiation of the blood thinner edoxaban in AF patients who have had a recent stroke. The aim is to determine if early initiation is safe, and if so, what predictors of hemorrhagic transformation after stroke exist.

Who is the study for?
This trial is for adults over 18 with atrial fibrillation and acute ischemic stroke diagnosed within the last five days. Participants must have confirmed ischemic stroke via CT/MRI or clinical symptoms, and provide informed consent. Excluded are those with severe kidney issues, known edoxaban allergy, high bleeding risk, certain brain conditions like hemorrhage or tumors, hereditary bleeding disorders, or any condition deemed risky by investigators.Check my eligibility
What is being tested?
The LASER trial is testing how safe it is to start taking the drug edoxaban early (within 5 days) versus later (6-14 days) after a cardioembolic stroke caused by atrial fibrillation. It's a randomized controlled study where patients are put into two groups: one starts treatment early and the other starts treatment later.See study design
What are the potential side effects?
Edoxaban may cause side effects such as bleeding complications including gastrointestinal bleeds or increased risk of hemorrhagic transformation in the brain following an ischemic stroke.

LASER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had a stroke confirmed by a scan within the last 5 days.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with Atrial Fibrillation, confirmed by tests or medical history.

LASER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 7 and 90 after edoxaban initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 7 and 90 after edoxaban initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of incident radiological hemorrhagic transformation (HT)
Secondary outcome measures
Ability of leukocyte RNA to predict HT.
EQ-5D and Visual Analog Scale (VAS)
Mortality
+7 more

LASER Trial Design

2Treatment groups
Experimental Treatment
Group I: Early initiation of edoxabanExperimental Treatment2 Interventions
Participants will be initiated on edoxaban within ≤ 5 days following ischemic stroke
Group II: Delayed initiation of edoxabanExperimental Treatment2 Interventions
Participants will be initiated on edoxaban within 6-14 days following ischemic stroke
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Edoxaban 30 mg
2016
Completed Phase 4
~80
Edoxaban 60 MG
2018
Completed Phase 4
~170

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
884 Previous Clinical Trials
392,910 Total Patients Enrolled
10 Trials studying Ischemic Stroke
938 Patients Enrolled for Ischemic Stroke
Brian Buck, MDPrincipal Investigatorprinciple investigator
Ken Butcher, MDPrincipal InvestigatorPrinicple Investigator

Media Library

Edoxaban 30 mg (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT03494530 — Phase 4
Ischemic Stroke Research Study Groups: Early initiation of edoxaban, Delayed initiation of edoxaban
Ischemic Stroke Clinical Trial 2023: Edoxaban 30 mg Highlights & Side Effects. Trial Name: NCT03494530 — Phase 4
Edoxaban 30 mg (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03494530 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What pathologies commonly benefit from this therapeutic intervention?

"This therapeutic option may be leveraged to prevent, mitigate and/or treat systemic embolism, pulmonary embolism and other related conditions."

Answered by AI

Does this clinical trial currently require additional participants?

"According to clinicaltrials.gov, this research project is open for recruitment - first posted on June 1st 2018 and last updated April 6th 2022."

Answered by AI

Has this treatment been granted authorization by the FDA?

"With Phase 4 trial data supporting its safety, this treatment was given a rating of 3 by Power."

Answered by AI

Is this a novel endeavor in the field of clinical trials?

"Currently, 23 trials are being conducted in 153 cities and 35 countries that involve this particular treatment. The first of these was sponsored by Daiichi Sankyo Europe, GmbH in 2016 with a cohort size of 2545 participants. It successfully completed its Phase 3 approval stage and since then 57 studies have been concluded."

Answered by AI

What is the maximum number of participants this research endeavor can accommodate?

"Affirmative. Clinicaltrials.gov provides evidence that this experiment, which was initially posted on June 1st 2018, is actively enrolling subjects. 150 people have to be enrolled from a single site."

Answered by AI
~22 spots leftby Mar 2025