A Phase 3 interventional study of Levetiracetam and Guide-recommended management in Suspected Stroke, sponsored by Shanghai East Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Shanghai East Hospital · Phase 3, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 2,423 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Shanghai East Hospital is the lead sponsor of 92 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Prophylactic use of LEV in the ambulance
Drug: Levetiracetam
Guide-recommended management
Other: Guide-recommended management
Lie flat
Other: The lying flat (0°) head position
Sit up
Other: The sitting-up (≥30°) head position
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
To receive stroke management according to standard local guidelines, but to avoid prophylactic use of an anti-seizure drug.
Lie flat (0°) - in the ambulance as soon as possible until arrival at hospital.
Sit up(30-60°) - in the ambulance as soon as possible until arrival at hospital.
Functional shift (improvement) in 7-level mRS scores
Time frame: 90 days
neurological severity on the National Institute of Health stroke scale (NIHSS)
0-42, higher scores indicates worse severity
Time frame: 24 hours from randomization
neurological severity on the National Institute of Health stroke scale (NIHSS)
0-42, higher scores indicates worse severity
Time frame: 7 days
health related quality of life on the EQ-5D-5L
Time frame: 90 days
severe disability (mRS 3-5)
Time frame: 90 days
death and/or severe disability (mRS 3-6)
Time frame: 90 days
utility-weighted-mRS (UW-mRS)
Time frame: 90 days
proportion of hospital discharge at Day 7
Time frame: 7 days
living circumstances questions
living at home \[the individual's own or that of a family member\] or living at an institution(hospital, care facility, or other)
Time frame: 90 days
any seizures during follow-up
assessed by 6 screening questions modified from the Canadian Longitudinal Study on Aging-Epilepsy Algorithm (CLSA-EA)
Time frame: 90 days, 6 months, 12 months
haematoma volume
in patients with final diagnosis of ICH
Time frame: at hospital admission and 24 hours
Hematoma expansion
in patients with final diagnosis of ICH
Time frame: 24 hours
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Shanghai East Hospital