Acute Stroke: Prehospital Versus In-HospitAL Initiation of Recanalization Therapy- ASPHALT

Recruiting now · Not applicable

Conditions studied: Stroke, Acute

In brief

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.

Key facts

Study ID

NCT05649670

Run by

Centre Hospitalier St Anne

People needed

450

Starts

2023-10-16

Expected to finish

2027-06-16

Last updated by the study team

2024-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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))

You may not qualify if…

• 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

Where it is running

• Hôpital Foch — Suresnes, France (enrolling)
• AP-HP - hôpital Bicêtre — Le Kremlin-Bicêtre, France (enrolling)
• AP-HP - hôpital Lariboisière — Paris, France (enrolling)
• AP-HP - hôpital de la Pitié-Salpêtrière — Paris, France (enrolling)
• GHU Paris psychiatrie & neurosciences — Paris, France (enrolling)
• SAMU 75 de Paris — Paris, France (enrolling)
• BSPP, Brigade des Sapeurs-Pompiers de Paris — Paris, France (enrolling)
• AP-HP - hôpital Bichat - Claude-Bernard — Paris, France (enrolling)
• Fondation Ophtalmologique Rothschild — Paris, France (enrolling)
• AP-HP - hôpital Raymond Poincaré — Garches, France (enrolling)
• Hôpital Saint Joseph — Paris, France

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.