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Early Initiated Ambulance-delivered Levetiracetam and Headposition in Hyper-acute Stroke Trial

ConditionSuspected Stroke
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai East Hospital

About this trial

This is an investigator initiated and conducted, multicentre, ambulance-delivered, prospective, randomised, open-label, blinded outcome (PROBE) study. EAST aims to evaluate the effects of pre-hospital levetiracetam and different head positions initiated in ambulance settings on the functional outcome of participants assessed at 90 days.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (age ≥18 years);

Acute condition that is presumed due to acute stroke, defined on the FAST (Face, Arm, Speech, Time) screen (score ≥2 with an arm deficit);

Time ≤2 hours from last seen well;

Able to provide brief consent (if a waver of consent not approved by ethics committee).

Disqualifiers

coma (no response to painful stimulation);

severe co-morbid disease (e.g. cancer, chronic airflow disease, severe dementia, severe heart failure, pre-existing disability [needing help with everyday activities]);

history of epilepsy or seizure at onset;

recent head injury;

Trial design

Design model

Factorial

Treatments tested in this trial

  • Levetiracetam

    Drug

    Intervention group - to commence IV levetiracetam 500mg as a single bolus in the ambulance, and then to continue as levetiracetam 500mg bid orally after admission to hospital in those with confirmed acute stroke for the next 14 days (at least 7 days if either dead or discharged from hospital if earlier). They will also receive standard management of acute stroke, whether the final diagnosis is ischaemic or ICH

  • Guide-recommended management

    Other intervention

    To receive stroke management according to standard local guidelines, but to avoid prophylactic use of an anti-seizure drug.

  • The lying flat (0°) head position

    Other intervention

    Lie flat (0°) - in the ambulance as soon as possible until arrival at hospital.

  • The sitting-up (≥30°) head position

    Other intervention

    Sit up(30-60°) - in the ambulance as soon as possible until arrival at hospital.

Treatment groups

2,423 Participants
are divided into 4 treatment groups
Group A: LevetiracetamExperimental treatment 1 intervention
Group B: Guide-recommended managementActive comparator 1 intervention
Group C: Lie flatExperimental treatment 1 intervention
Group D: Sit upActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Functional shift (improvement) in 7-level mRS scores

Time frame
90 days

Secondary outcomes

1

neurological severity on the National Institute of Health stroke scale (NIHSS)

0-42, higher scores indicates worse severity

Time frame
24 hours from randomization
2

neurological severity on the National Institute of Health stroke scale (NIHSS)

0-42, higher scores indicates worse severity

Time frame
7 days
3

health related quality of life on the EQ-5D-5L

Time frame
90 days
4

severe disability (mRS 3-5)

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai East Hospital

Lead sponsor

Source ClinicalTrials.gov
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