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NCT05649670
Acute Stroke: Prehospital Versus In-HospitAL Initiation of Recanalization Therapy- ASPHALT
Conditions: Stroke, Acute
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 450
Sponsor: Centre Hospitalier St Anne
Location: France
Summary
ASPHALT is an academic-driven open-label randomized controlled trial of Mobile Stroke Unit (MSU) deployment versus standard care in France, with blinded assessment of efficacy endpoints.
450 patients with confirmed acute ischemic stroke will be recruited over a 3-year period, with 3-month follow-up.
Eligibility Criteria
Inclusion Criteria:Emergency call to one of the two following emergency medical service (EMS) dispatch centers : SAMU (Service d'Aide Médicale Urgente) or BSPP (Brigade des Sapeurs Pompiers de Paris), between 08:00 and 18:00, 5 days a week (Monday to Friday).Suspected acute stroke according to a dispatcher stroke identification algorithm, adapted from the ROSIER scaleSymptom onset-to-randomization time ≤ 6hPatient located within the predefined catchment area of the MSUMSU available at the time of the EMS callInformed consent (as approved by the ethics committee, informed consent will be obtained after randomization: at the arrival of the MSU (intervention group), or at hospital arrival (control group))Exclusion Criteria:Patient confined to be more than 50% of waking hoursUnknown or uncertain onset time (e.g.
wake-up stroke)Medical history of epilepsyRecent epileptic seizure (<12 hrs)Suspicion of pregnancyParturient or breastfeeding womanPatient already participating in another interventional study, which could influence the mRS at 3 months.Patient under guardianship or curatorshipPatient not affiliated to French Social Security
Source: ClinicalTrials.gov (NCT05649670). StuddyBuddy aggregates publicly available trial information.