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Edoxaban for Stroke in Atrial Fibrillation Patients (LASER Trial)
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.
LASER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowLASER Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.LASER Trial Design
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Who is running the clinical trial?
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- You are allergic to edoxaban.I had a stroke confirmed by a scan within the last 5 days.I am 18 years old or older.My kidney function is severely reduced.I have conditions that look like a stroke but aren't.I have had a recent brain bleed or related brain condition.I have a bleeding disorder that is inherited or developed.I have been diagnosed with Atrial Fibrillation, confirmed by tests or medical history.I have a mild to moderate brain bleed shown on my CT scan.I do not have any current or recent significant bleeding issues.
- Group 1: Early initiation of edoxaban
- Group 2: Delayed initiation of edoxaban
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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