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

NCT06773364 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai East Hospital

Phase

Phase 3

Started

2025-04-30

Last updated

2025-05-22

Condition(s) studied

Suspected Stroke

Investigational drug(s) / intervention(s)

Levetiracetam →Guide-recommended managementThe lying flat (0°) head positionThe sitting-up (≥30°) head position

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

The sitting-up (≥30°) head position: Sit up(30-60°) - in the ambulance as soon as possible until arrival at hospital.

Study summary

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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). Exclusion Criteria: * 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; * hypoglycaemia (glucose \<2.8mmol/L); * clear indications or contraindications (allergies) for levetiracetam; * 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.).

Primary outcome measure(s)

Functional shift (improvement) in 7-level mRS scores — 90 days

Trial sites (2)

Facility	City	Region	Status
Si County People's Hospital	Suzhou	Anhui	Recruiting
Shanghai East Hospital	Shanghai	Shanghai Municipality	Recruiting

On this site

📄 Keppra (levetiracetam) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06773364 on ClinicalTrials.gov ↗ ← All trials in China