Suspected StrokePhase 3EASTNCT06773364
Early Initiated Ambulance-delivered Levetiracetam and Headposition in Hyper-acute Stroke Trial
A Phase 3 study testing Levetiracetam, Guide-recommended management and The lying flat (0°) head position in people with Suspected Stroke, run by Shanghai East Hospital at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suspected Stroke
- What is being tested?
- Levetiracetam, Guide-recommended management and The lying flat (0°) head position
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,423 participants
- Where
- 2 sitesChina
- Study dates
- 30 Apr 2025to 31 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chen Chen, PhD, MD contact
China2 sites, 2 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123
Chen Chen, MD PhD, 86 15921119641, 15921119641@163.com
- Recruiting
Si County People's Hospital
Suzhou, Anhui, 234399
Lei Shi, 86 18755733255, 275386217@qq.com
About this study
Official title: An Investigator Initiated and Conducted, Prospective, Multicentre, Randomised Outcome-blinded Study of Pre-hospital Initiated Levetiracetam and Headposition in Patients With Presumed Acute Stroke
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.
Read the 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
- Being tested
- Levetiracetam, Guide-recommended management, The lying flat (0°) head position, The sitting-up (≥30°) head position
- Keywords
- Ambulance, Acute stroke, Levetiracetam, Head position, intervention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
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 managementOther
To receive stroke management according to standard local guidelines, but to avoid prophylactic use of an anti-seizure drug.
The lying flat (0°) head positionOther
Lie flat (0°) - in the ambulance as soon as possible until arrival at hospital.
The sitting-up (≥30°) head positionOther
Sit up(30-60°) - in the ambulance as soon as possible until arrival at hospital.
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam | Experimental | Prophylactic use of LEV in the ambulance Receives: Drug: Levetiracetam |
| Guide-recommended management | Active comparator | Guide-recommended management Receives: Other: Guide-recommended management |
| Lie flat | Experimental | Lie flat Receives: Other: The lying flat (0°) head position |
| Sit up | Active comparator | Sit up Receives: Other: The sitting-up (≥30°) head position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional shift (improvement) in 7-level mRS scores
Measured: 90 days
Secondary outcomes (11)
neurological severity on the National Institute of Health stroke scale (NIHSS)
0-42, higher scores indicates worse severity
Measured: 24 hours from randomization
neurological severity on the National Institute of Health stroke scale (NIHSS)
0-42, higher scores indicates worse severity
Measured: 7 days
health related quality of life on the EQ-5D-5L
Measured: 90 days
severe disability (mRS 3-5)
Measured: 90 days
death and/or severe disability (mRS 3-6)
Measured: 90 days
utility-weighted-mRS (UW-mRS)
Measured: 90 days
proportion of hospital discharge at Day 7
Measured: 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)
Measured: 90 days
any seizures during follow-up
assessed by 6 screening questions modified from the Canadian Longitudinal Study on Aging-Epilepsy Algorithm (CLSA-EA)
Measured: 90 days, 6 months, 12 months
haematoma volume
in patients with final diagnosis of ICH
Measured: at hospital admission and 24 hours
Hematoma expansion
in patients with final diagnosis of ICH
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start30 Apr 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspected StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,423 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gang Li, PhD, MD, Principal investigator, Tongji University, School of Medicine, Shanghai East HospitalCraig Anderson, MD, PhD, Principal investigator, Fudan UniversityLili Song, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773364
- Sponsor's protocol ID
- 2024-228
- Acronym
- EAST
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator Initiated and Conducted, Prospective, Multicentre, Randomised Outcome-blinded Study of Pre-hospital Initiated Levetiracetam and Headposition in Patients With Presumed Acute Stroke
- ClinicalTrials.gov ID
- NCT06773364
- Acronym / sponsor ID
- EAST / 2024-228
- Conditions
- Suspected Stroke
- Keywords
- Ambulance, Acute stroke, Levetiracetam, Head position, intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,423 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam | Experimental | Drug: LevetiracetamProphylactic use of LEV in the ambulance |
| Guide-recommended management | Active comparator | Other: Guide-recommended managementGuide-recommended management |
| Lie flat | Experimental | Other: The lying flat (0°) head positionLie flat |
| Sit up | Active comparator | Other: The sitting-up (≥30°) head positionSit up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevetiracetamIntervention 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 | Drug | Levetiracetam |
| Guide-recommended managementTo receive stroke management according to standard local guidelines, but to avoid prophylactic use of an anti-seizure drug. | Other | Guide-recommended management |
| The lying flat (0°) head positionLie flat (0°) - in the ambulance as soon as possible until arrival at hospital. | Other | Lie flat |
| The sitting-up (≥30°) head positionSit up(30-60°) - in the ambulance as soon as possible until arrival at hospital. | Other | Sit up |
Primary outcome
Functional shift (improvement) in 7-level mRS scores
Time frame: 90 days
11 secondary outcomes
neurological severity on the National Institute of Health stroke scale (NIHSS)
Time frame: 24 hours from randomization
neurological severity on the National Institute of Health stroke scale (NIHSS)
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
Time frame: 90 days
any seizures during follow-up
Time frame: 90 days, 6 months, 12 months
haematoma volume
Time frame: at hospital admission and 24 hours
Hematoma expansion
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chen Chen, PhD, MD contact
Gang Li, PhD, MD principal investigator
Tongji University, School of Medicine, Shanghai East Hospital
Craig Anderson, MD, PhD principal investigator
Fudan University
Lili Song, PhD principal investigator
Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levetiracetam, Guide-recommended management and The lying flat (0°) head position in people with Suspected Stroke, run by Shanghai East Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gang Li, PhD, MD (86 13621691786, ligang@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional shift (improvement) in 7-level mRS scores (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.