NCT06773364RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 22 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 2423 (estimated)
- First submitted
- 2 Jan 2025
- Start date
- 30 Apr 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Shanghai East Hospital
- Diseases
- Stroke
- NCT number
- NCT06773364
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 2423
- From 30 Apr 2025 to the primary completion date, 31 Dec 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- clear indications or contraindications (allergies) for levetiracetam;
Lab values
- hypoglycaemia (glucose \<2.8mmol/L);
Other
- coma (no response to painful stimulation);
- recent head injury;
- 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.).
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai East Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Si County People's Hospital Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.