Early Initiated Ambulance-delivered Levetiracetam and Headposition in Hyper-acute Stroke Trial (NCT06773364) | Clinical Trial Compass
RecruitingPhase 3
Early Initiated Ambulance-delivered Levetiracetam and Headposition in Hyper-acute Stroke Trial
China2,423 participantsStarted 2025-04-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.).
What they're measuring
1
Functional shift (improvement) in 7-level mRS scores