NCT05649670 Acute Stroke: Prehospital Versus In-HospitAL Initiation of Recanalization Therapy- ASPHALT
| NCT ID | NCT05649670 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier St Anne |
| Condition | Stroke, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2023-10-16 |
| Primary Completion | 2026-10-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 450 participants in total. It began in 2023-10-16 with a primary completion date of 2026-10-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 scale * Symptom onset-to-randomization time ≤ 6h * Patient located within the predefined catchment area of the MSU * MSU available at the time of the EMS call * Informed 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 hours * Unknown or uncertain onset time (e.g. wake-up stroke) * Medical history of epilepsy * Recent epileptic seizure (\<12 hrs) * Suspicion of pregnancy * Parturient or breastfeeding woman * Patient already participating in another interventional study, which could influence the mRS at 3 months. * Patient under guardianship or curatorship * Patient not affiliated to French Social Security
Contact & Investigator
Guillaume TURC, MD, PhD
PRINCIPAL INVESTIGATOR
GHU Paris Psychiatrie et Neurosciences
Frequently Asked Questions
Who can join the NCT05649670 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05649670 currently recruiting?
Yes, NCT05649670 is actively recruiting participants. Contact the research team at k.sylla@ghu-paris.fr for enrollment information.
Where is the NCT05649670 trial being conducted?
This trial is being conducted at Garches, France, Le Kremlin-Bicêtre, France, Paris, France, Paris, France and 7 additional locations.
Who is sponsoring the NCT05649670 clinical trial?
NCT05649670 is sponsored by Centre Hospitalier St Anne. The principal investigator is Guillaume TURC, MD, PhD at GHU Paris Psychiatrie et Neurosciences. The trial plans to enroll 450 participants.
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