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Taking people in ChinaPhase 3

Tests levetiracetam and head position for suspected stroke in ambulances

Tests an early ambulance drug and head position in adults with suspected stroke.

Key facts

Who runs it
Shanghai East Hospital
Where
Shanghai and Suzhou, ChinaSee the 2 sites
Trial code
Registry title
Early Initiated Ambulance-delivered Levetiracetam and Headposition in Hyper-acute Stroke Trial
Status
Recruiting
Phase
Phase 3
People taking part
2,423 people, planned
Started
30 Apr 2025
Expected to end
31 Dec 2029
Type of study
Interventional, 4 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Levetiracetam
  • Guide-recommended management
  • The lying flat (0°) head position
  • The sitting-up (≥30°) head position
Record updated
22 May 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with sudden symptoms that may be a stroke, first seen by an ambulance crew within 2 hours of last being well.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Sudden condition thought to be a stroke, with a FAST screen score of 2 or more including an arm weakness, and no more than 2 hours since last seen well.

Main reasons for not taking part

  • Coma (no response to painful stimulation)
  • Severe other illness, such as cancer, severe dementia or pre-existing disability
  • History of epilepsy, or a seizure at the start of symptoms
  • Recent head injury or low blood sugar (glucose below 2.8mmol/L (50 mg/dL))
  • Breastfeeding women

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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
  • clear indications or contraindications (allergies) for levetiracetam
  • hypoglycaemia (glucose <2.8mmol/L)
  • coma (no response to painful stimulation)
  • recent head injury
  • lactating women
  • clear indications for a particular head position or situations where either head position cannot be maintained (such as severe vomiting and inability to lie down, severe obesity with fatigue and difficulty sitting up, etc.)

Where in China

  • Shanghai East HospitalShanghai, ChinaContact: Chen Chen, MD PhDTaking people
  • Si County People's HospitalSuzhou, ChinaContact: Lei ShiTaking people

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • LevetiracetamTreatment being tested

    Prophylactic use of LEV in the ambulance

  • Guide-recommended managementExisting treatment, for comparison
  • Lie flatTreatment being tested

    Treatment: The lying flat (0°) head position

  • Sit upExisting treatment, for comparison

    Treatment: The sitting-up (≥30°) head position

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
An Investigator Initiated and Conducted, Prospective, Multicentre, Randomised Outcome-blinded Study of Pre-hospital Initiated Levetiracetam and Headposition in Patients With Presumed Acute Stroke
Plain-language title
Tests levetiracetam and head position for suspected stroke in ambulancesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
22 May 2025