Status:
COMPLETED
Eliquis Acute Stroke Safety Evaluation
Lead Sponsor:
University of Alberta
Conditions:
Ischemic Stroke
Transient Ischemic Attack
Eligibility:
All Genders
18+ years
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 foc...
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 D...
Eligibility Criteria
Inclusion
- 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
- 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 ≤2.0.
- 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.)
Key Trial Info
Start Date :
March 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 9 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04435418
Start Date
March 1 2017
End Date
September 9 2019
Last Update
June 19 2020
Active Locations (1)
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1
University of Alberta
Edmonton, Alberta, Canada