Ischemic StrokeEASSENCT04435418
Eliquis Acute Stroke Safety Evaluation
An observational study of Ischemic Stroke and Transient Ischemic Attack, run by University of Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Transient Ischemic Attack, Atrial Fibrillation
- What is being tested?
- Apixaban
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2017to 9 Sep 2019
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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:
Case report forms and data monitoring will be completed on site. All imaging data will be read centrally at the Stroke Imaging Laboratory at the University of Alberta.
Procedures:
Apixaban therapy: The apixaban dose will be determined by the treating physician, based on age, weight and renal function as per the product monograph. Patients with two of the following: Age > 80, weight < 60 kg, and creatinine ≥ 133 (1.5 mg/dl), will have received 2.5 mg twice a day. All other patients will have received 5 mg twice a day.
Imaging Procedures and Analysis:
Anonymized dicom CT data will be analyzed centrally. Baseline infarct volumes will be measured using planimetric techniques and recurrent infarctions will be identified. Any HT seen at baseline and day 7 will be graded using European Cooperative Acute Stroke Study (ECASS) criteria.
Endpoints:
The primary endpoint is the symptomatic HT, defined as PH2 associated with a ≥4-point increase in NIHSS score within 90 days of initiating apixaban therapy. Secondary outcomes include any HT at day 7, systemic hemorrhagic complications, and recurrent ischemic events within 90 days of enrolment. Investigators will report serious adverse events (SAE) within the study period using standardized event, resolution and association codes, and they will be reported to the local Human Research Ethics Board.
Sample Size:
A sample of 100 patients is planned in order to obtain estimates of the frequency of symptomatic and asymptomatic HT associated with early apixaban initiation. The maximum acceptable rate of symptomatic HT is considered 2%, based on a meta-analysis of low molecular weight heparin treatment in acute stroke, indicating the absolute symptomatic HT rate ranged from 2.4% to 2.9%.
- Being tested
- Apixaban
- Keywords
- Atrial fibrillation, Ischemic stroke, Hemorrhagic transformation, Apixaban, Cardioembolic stroke, Intracerebral hemorrhage
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient, Atrial Fibrillation, Embolic Stroke, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called Eliquis
The decision to treat with apixaban and the timing of initiation will be at the attending physicians' discretion, independent of enrolment in EASSE.
What is being measured
The primary outcome is the main question the study is designed to answer.
symptomatic HT
Defined as PH2 associated with a ≥4-point increase in NIHSS score within 90 days of initiating apixaban therapy
Measured: 90 days
Secondary outcomes (3)
HT
Symptomatic or asymptomatic
Measured: Day 7
Systemic hemorrhagic complications
Systemic bleeding
Measured: 90 days
Recurrent ischemic events
TIA, ischemic stroke, or systemic emboli
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start1 Mar 2017
- Primary completion9 Sep 2019
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ken Butcher, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435418
- Sponsor's protocol ID
- Version 1.0 September 30, 2016
- Acronym
- EASSE
- Status last verified
- Jun 2020
- First submitted
- 14 Jun 2020
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eliquis Acute Stroke Safety Evaluation
- ClinicalTrials.gov ID
- NCT04435418
- Acronym / sponsor ID
- EASSE / Version 1.0 September 30, 2016
- Keywords
- Atrial fibrillation, Ischemic stroke, Hemorrhagic transformation, Apixaban, Cardioembolic stroke, Intracerebral hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
Case report forms and data monitoring will be completed on site. All imaging data will be read centrally at the Stroke Imaging Laboratory at the University of Alberta.
Procedures:
Apixaban therapy: The apixaban dose will be determined by the treating physician, based on age, weight and renal function as per the product monograph. Patients with two of the following: Age > 80, weight < 60 kg, and creatinine ≥ 133 (1.5 mg/dl), will have received 2.5 mg twice a day. All other patients will have received 5 mg twice a day.
Imaging Procedures and Analysis:
Anonymized dicom CT data will be analyzed centrally. Baseline infarct volumes will be measured using planimetric techniques and recurrent infarctions will be identified. Any HT seen at baseline and day 7 will be graded using European Cooperative Acute Stroke Study (ECASS) criteria.
Endpoints:
The primary endpoint is the symptomatic HT, defined as PH2 associated with a ≥4-point increase in NIHSS score within 90 days of initiating apixaban therapy. Secondary outcomes include any HT at day 7, systemic hemorrhagic complications, and recurrent ischemic events within 90 days of enrolment. Investigators will report serious adverse events (SAE) within the study period using standardized event, resolution and association codes, and they will be reported to the local Human Research Ethics Board.
Sample Size:
A sample of 100 patients is planned in order to obtain estimates of the frequency of symptomatic and asymptomatic HT associated with early apixaban initiation. The maximum acceptable rate of symptomatic HT is considered 2%, based on a meta-analysis of low molecular weight heparin treatment in acute stroke, indicating the absolute symptomatic HT rate ranged from 2.4% to 2.9%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApixabanAlso: EliquisThe decision to treat with apixaban and the timing of initiation will be at the attending physicians' discretion, independent of enrolment in EASSE. | Drug | – |
Primary outcome
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
3 secondary outcomes
HT
Time frame: Day 7
Systemic hemorrhagic complications
Time frame: 90 days
Recurrent ischemic events
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Transient Ischemic Attack, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptomatic HT (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2020.