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

Phase 3

Recruiting

• Conditions: Suspected Stroke
• Interventions: Other: The lying flat (0°) head position; Drug: Levetiracetam; Other: Guide-recommended management; Other: The sitting-up (≥30°) head position

• Registration Number: NCT06773364
• Lead Sponsor: Shanghai East Hospital

Brief 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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-13
• Study First Posted: 2025-01-14
• Study Start: 2025-04-30
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2423

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Lie flat	The lying flat (0°) head position	Lie flat
Levetiracetam	Levetiracetam	Prophylactic use of LEV in the ambulance
Guide-recommended management	Guide-recommended management	Guide-recommended management
Sit up	The sitting-up (≥30°) head position	Sit up

Primary Outcome Measures

Name	Time	Method
Functional shift (improvement) in 7-level mRS scores	90 days

Secondary Outcome Measures

Name	Time	Method
health related quality of life on the EQ-5D-5L	90 days
neurological severity on the National Institute of Health stroke scale (NIHSS)	7 days	0-42, higher scores indicates worse severity
severe disability (mRS 3-5)	90 days
death and/or severe disability (mRS 3-6)	90 days
any seizures during follow-up	90 days, 6 months, 12 months	assessed by 6 screening questions modified from the Canadian Longitudinal Study on Aging-Epilepsy Algorithm (CLSA-EA)
Hematoma expansion	24 hours	in patients with final diagnosis of ICH
utility-weighted-mRS (UW-mRS)	90 days
proportion of hospital discharge at Day 7	7 days
living circumstances questions	90 days	living at home \[the individual's own or that of a family member\] or living at an institution(hospital, care facility, or other)
haematoma volume	at hospital admission and 24 hours	in patients with final diagnosis of ICH

Trial Locations

Locations (2)

Si County People's Hospital; 🇨🇳 Suzhou, Anhui, China

Shanghai East Hospital; 🇨🇳 Shanghai, Shanghai, China