MedTrace Logo

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

NCT06773364 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2423

Last updated 2025-05-22

No results posted yet for this 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.

Conditions

  • Suspected Stroke

Interventions

DRUG

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

OTHER

Guide-recommended management

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

OTHER

The lying flat (0°) head position

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

OTHER

The sitting-up (≥30°) head position

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

Sponsors & Collaborators

  • Shanghai East Hospital

    lead OTHER

Principal Investigators

  • Gang Li, PhD, MD · Tongji University, School of Medicine, Shanghai East Hospital

  • Craig Anderson, MD, PhD · Fudan University

  • Lili Song, PhD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06773364 on ClinicalTrials.gov