Eliquis Acute Stroke Safety Evaluation

NCT04435418 | Completed DMC FDA Drug

• 1 other identifier: Version 1.0 September 30, 2016
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Transient Ischemic Attack; Atrial Fibrillation

Keywords

Atrial fibrillation; Ischemic stroke; Hemorrhagic transformation; Apixaban; Cardioembolic stroke; Intracerebral hemorrhage

Outcome Measures

Primary Outcomes (1)

• symptomatic HT

  Defined as PH2 associated with a ≥4-point increase in NIHSS score within 90 days of initiating apixaban therapy

  90 days

Secondary Outcomes (3)

• HT

  Day 7

• Systemic hemorrhagic complications

  90 days

• Recurrent ischemic events

  90 days

Interventions

Apixaban DRUG

The decision to treat with apixaban and the timing of initiation will be at the attending physicians' discretion, independent of enrolment in EASSE.

Also known as: Eliquis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with ischemic stroke (regardless of the size and severity ) or TIA in patients ≥ 18 years of age, with atrial fibrillation (newly or previously diagnosed), who can be treated with apixaban following stroke.

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient; Atrial Fibrillation; Embolic Stroke; Cerebral Hemorrhage

Interventions

apixaban

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 14, 2020
• First Posted: June 17, 2020
• Study Start: March 1, 2017
• Primary Completion: September 9, 2019
• Study Completion: September 9, 2019
• Last Updated: June 19, 2020

Record last verified: 2020-06

Locations

CA (1)