Lixiana Acute Stroke Evaluation Registry

NCT03494530 | Completed Phase 4

• 1 other identifier: Version 4.0
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke; Atrial Fibrillation; Hemorrhagic Transformation Stroke

Keywords

atrial fibrillation; ischemic stroke; Hemorrhagic transformation; Edoxaban; cardioembolic stroke; Intracerebral hemorrhage

Outcome Measures

Primary Outcomes (1)

• Rate of incident radiological hemorrhagic transformation (HT)

  Follow up CT scan at 7±2 days after edoxaban initiation

Secondary Outcomes (10)

• Rate of symptomatic hemorrhagic transformation (HT)

  Within 30 days of edoxaban initiation.

• Recurrent ischemic events

  Within 90 days of randomization

• Recurrent sub-clinical infarcts

  Follow up CT scan at 7±2 days after edoxaban initiation

• systemic hemorrhagic complication rate

  Within 90 days of randomization

• NIHSS

  At day 7 and 90 after edoxaban initiation

Study Arms (2)

Early initiation of edoxaban

OTHER

Participants will be initiated on edoxaban within ≤ 5 days following ischemic stroke

Drug: Edoxaban 60 MG; Drug: Edoxaban 30 mg

Delayed initiation of edoxaban

OTHER

Participants will be initiated on edoxaban within 6-14 days following ischemic stroke

Drug: Edoxaban 60 MG; Drug: Edoxaban 30 mg

Interventions

Edoxaban 60 MG DRUG

Anticoagulant used to treat atrial fibrillation

Also known as: Lixiana

Delayed initiation of edoxaban; Early initiation of edoxaban

Edoxaban 30 mg DRUG

Anticoagulant used to treat atrial fibrillation

Also known as: Lixiana

Delayed initiation of edoxaban; Early initiation of edoxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients
• years of age or older
• 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)
• Atrial Fibrillation (AF, paroxysmal or persistent), confirmed with ECG/Holter monitor, or by history (clinical documentation of previous AF must be provided).
• Informed consent

You may not qualify if:

• Acute or chronic renal failure, defined as eGFR \<30 ml/min (Cockcroft Gault formula).
• Known hypersensitivity to edoxaban.
• Any significant ongoing systemic bleeding risk, i.e. active GI/GU bleeding or recent major surgery.
• Recent past history or clinical presentation of ICH, subarachnoid haemorrhage (SAH), arterio-venous malformation (AVM), aneurysm, or cerebral neoplasm.
• Hereditary or acquired hemorrhagic diathesis.
• Stroke mimics
• HT with a grade of parenchymal hemorrhage (PH1 or PH2) on baseline or screening CT. They will be eligible for the registry portion of LASER and follow-up will be identical to that in the trial.
• Any condition that, in the judgment of the investigator(s), could impose hazards to the patient if study therapy is initiated

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2B7, Canada

Location

Related Publications (1)

• 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.

  PMID: 33868150 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Atrial Fibrillation; Embolic Stroke; Cerebral Hemorrhage

Interventions

edoxaban

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Hemorrhages; Hemorrhage

Study Officials

• Brian Buck, MD

  principle investigator

  PRINCIPAL INVESTIGATOR

• Ken Butcher, MD

  Prinicple Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 11, 2018
• Study Start: June 1, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 5, 2024

Record last verified: 2024-04

Locations

CA (1)