Eliquis Acute Stroke Safety Evaluation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Alberta
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- symptomatic HT
Study Overview
Brief Summary
Study Design:
This is an investigator-initiated prospective, open label, single arm phase IV study. Patients with documented non-valvular atrial fibrillation (AF) with acute TIA (defined as acute focal neurological deficits, with complete resolution of symptoms within 24 h of onset) or ischemic stroke, irrespective of infarct volume or clinical severity will be enrolled.
Study Aim and Objectives:
The overall aim of this study is to demonstrate the feasibility and safety of initiating apixaban therapy within 14 days of TIA or ischemic stroke regardless of the size and severity in patients with AF. Investigators will systematically assess prospectively collected CT scan images for evidence of HT and re-infarction.
Detailed Description
Study Hypothesis:
Investigators hypothesize that early initiation of apixaban within the first 14 days of stroke or TIA is not associated with increased symptomatic intracranial haemorrhage.
Study Design:
EASSE is an investigator-initiated prospective, open label, single arm phase IV study. Consecutive patients with AF (new onset or previous history) with acute ischemic stroke or TIA will be screened from Emergency Department or stroke unit. A total of 100 patients will be recruited within 24 hours of initiation of apixaban after TIA or stroke. All study participants will be followed for 90 days after apixaban initiation. A National Institute of Health Stroke Scale (NIHSS) score, modified Rankin Scale (mRS), and Montreal Cognitive Assessment (MoCA) will be collected at baseline, 7, and 90 days after enrolment. All patients will have a non-contrast CT scan at baseline (within 24 hours from study recruitment) and at 7±2 days after enrolment. In the event of clinical deterioration, a repeat CT scan will be performed immediately.
Administrative Structure:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female patients
- •Must be ≥ 18 years of age.
- •Diagnosis of ischemic stroke, or Transient Ischemic Attack (TIA, defined as acute focal neurological deficits, with complete resolution of symptoms within 24 h of 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 apixaban 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 apixaban.
- •Prior treatment with apixaban or any other novel oral anticoagulant (including all Factor Xa antagonists). Treatment with warfarin prior to the stroke/TIA is acceptable, but enrolment cannot begin until the INR is ≤2.
- •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.
- •Hereditary or acquired haemorrhagic diathesis.
- •Stroke mimics (such as seizures, migraine etc.)
Outcomes
Primary Outcomes
symptomatic HT
Time Frame: 90 days
Defined as PH2 associated with a ≥4-point increase in NIHSS score within 90 days of initiating apixaban therapy
Secondary Outcomes
- Recurrent ischemic events(90 days)
- HT(Day 7)
- Systemic hemorrhagic complications(90 days)
Investigators
Ken Butcher
Professor
University of Alberta