Early Initiated Ambulance-delivered Levetiracetam and Headposition in Hyper-acute Stroke Trial
Recruiting now · Phase 3
Conditions studied: Suspected Stroke
In brief
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.
Key facts
- Study ID
- NCT06773364
- Run by
- Shanghai East Hospital
- People needed
- 2423
- Starts
- 2025-04-30
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2025-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.).
Where it is running
- Si County People's Hospital — Suzhou, Anhui, China (enrolling)
- Shanghai East Hospital — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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