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Lixiana Acute Stroke Evaluation Registry (LASER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494530
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Brief 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.


Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: Edoxaban 60 MG Drug: Edoxaban 30 mg Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lixiana Acute Stroke Evaluation Registry
Actual Study Start Date : November 4, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Edoxaban

Arm Intervention/treatment
Early initiation of edoxaban
Participants will be initiated on edoxaban within ≤ 5 days following ischemic stroke
Drug: Edoxaban 60 MG
Anticoagulant used to treat atrial fibrillation
Other Name: Lixiana

Drug: Edoxaban 30 mg
Anticoagulant used to treat atrial fibrillation
Other Name: Lixiana

Delayed initiation of edoxaban
Participants will be initiated on edoxaban within 6-14 days following ischemic stroke
Drug: Edoxaban 60 MG
Anticoagulant used to treat atrial fibrillation
Other Name: Lixiana

Drug: Edoxaban 30 mg
Anticoagulant used to treat atrial fibrillation
Other Name: Lixiana




Primary Outcome Measures :
  1. Rate of symptomatic hemorrhagic transformation (HT) [ Time Frame: Within 30 days of treatment initiation. ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients
  • 18 years of age or older
  • Diagnosis of minor ischemic stroke, or Transient Ischemic Attack (TIA, defined as acute focal neurological deficits, with complete resolution of symptoms within 24 h of onset) confirmed ≤5 days from symptom onset. In cases where onset time cannot be established, it will be considered to be the time when patient was last known to be well.
  • CT scan or MRI, with findings consistent with an ischemic etiology of symptoms.
  • Atrial Fibrillation (AF, paroxysmal or persistent), confirmed with ECG/Holter monitor, or by history (clinical documentation of previous AF must be provided).
  • Patients prescribed edoxaban by their treating physician following their stroke/TIA.
  • Ability to obtain consent from patient or legally authorized representative.

Exclusion Criteria:

  • 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.
  • Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
  • Recent past history or clinical presentation of ICH, subarachnoid haemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm. At the discretion of each Investigator.
  • Hereditary or acquired haemorrhagic diathesis.
  • Stroke mimics (such as seizures, migraine etc.)
  • Patients with spontaneous HT with a grade of PH1 or PH2 on the baseline or screening imaging will not be eligible for randomization. They will be included in the registry portion of LASER and follow-up will be identical to that in the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494530


Contacts
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Contact: Brian Buck, MD 780-248-1188 bbuck@ualberta.ca
Contact: Paige C Fairall 780-248-1118 fairall@ualberta.ca

Locations
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Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G2B7
Contact: Brian Buck, MD       bbuck@ualberta.ca   
Principal Investigator: Brian Buck, MD         
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Brian Buck, MD Principle Investigator
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03494530    
Other Study ID Numbers: Version 2.1
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Edoxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants