NCT06773364

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

An Investigator Initiated and Conducted, Prospective, Multicentre, Randomised Outcome-blinded Study of Pre-hospital Initiated Levetiracetam and Headposition in Patients With Presumed Acute Stroke

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,423 (estimated)
• Sponsor: Shanghai East Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

EAST is a multicenter, ambulance-delivered, prospective, randomized controlled, open label blinded outcome assessment (PROBE) study to be conducted through a regional-cluster hospital network of investigators. A total of 2323 patients with suspected acute stroke will be recruited from approximately 50 hospitals in China. Potentially eligible patients will be recruited into the study by either of two mechanisms: (1) waver of consent to the intervention, and consent to follow-up obtained in hospital; or (ii) consent to the intervention through a brief written consent which is combined with a usual care consent form delivered in hospital for follow-up (if a waver of consent is not approved by the ethics committee). All patients will enter Part A and Part B at the same time, randomised allocation of intervention will be done in a 1:1 ratio in each part, using a central, automated, mobile phone Wechat mini program-based electronic randomization software according to minimization method stratified by ambulance systems, age (≥65 vs \<65) and FAST(\>2 vs =2). The intervention of Part A is to commence IV levetiracetam(LEV) 500mg as a single bolus in the ambulance and then to continue as LEV 500mg Bid orally after hospital admission for 14 days(at least 7 days if discharged or death early), compared to avoid prophylactic use of antiseizure drugs. Part B is to lie flat or sit up in the ambulance as soon as possible until hospital arrival. Ambulance staff will be well trained across the whole study to master mobile randomisation and simple key data collection. All information in ambulance, including basic demographics, randomised allocation, BP measurement and treatment details, will be collected through mobile phone based electronic database system connected with investigator clinicians in hospitals. Other relevant documents such as consent paper, BP chart will be handed over to hospital investigators. Endpoint assessment will be blinded to treatment allocation.

Conditions

• Suspected Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-30
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2025-01-14
• Last updated: 2025-05-22

Locations

2 sites across 1 country: China