Early Initiated Ambulance-delivered Levetiracetam and Headposition in Hyper-acute Stroke Trial
Recruiting
Phase 3
Interventional Study
Suspected Stroke
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 2,423 (estimated)
- Sponsor
- Shanghai East Hospital · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 ethi…
Contacts