Lixiana Acute Stroke Evaluation Registry

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alberta
• Treatments: Edoxaban

Criteria

Inclusion Criteria:

1. Male or female patients

2. 18 years of age or older

3. 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)

4. Atrial Fibrillation (AF, paroxysmal or persistent), confirmed with ECG/Holter monitor, or by history (clinical documentation of previous AF must be provided).

5. Informed consent

Exclusion Criteria:

1. Acute or chronic renal failure, defined as eGFR <30 ml/min (Cockcroft Gault formula).

2. Known hypersensitivity to edoxaban.

3. Any significant ongoing systemic bleeding risk, i.e. active GI/GU bleeding or recent major surgery.

4. Recent past history or clinical presentation of ICH, subarachnoid haemorrhage (SAH), arterio-venous malformation (AVM), aneurysm, or cerebral neoplasm.

5. Hereditary or acquired hemorrhagic diathesis.

6. Stroke mimics

7. 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.

8. Any condition that, in the judgment of the investigator(s), could impose hazards to the patient if study therapy is initiated