NCT05649670Recruiting
Acute Stroke: Prehospital Versus In-HospitAL Initiation of Recanalization Therapy- ASPHALT
Prehospital Initiation of Reperfusion Therapy for Acute Ischemic Stroke: Randomized Medico-economic Evaluation of a Mobile Stroke Unit.
Source: ClinicalTrials.gov · Last updated 1 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- First submitted
- 2 Dec 2022
- Start date
- 16 Oct 2023
- Primary completion date
- 16 Oct 2026
- Lead sponsor
- Centre Hospitalier St Anne
- Diseases
- Stroke
- NCT number
- NCT05649670
What you commit to
- Study type: Interventional
- Planned participants: 450
- From 16 Oct 2023 to the primary completion date, 16 Oct 2026
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Unknown or uncertain onset time (e.g. wake-up stroke)
- Medical history of epilepsy
- Recent epileptic seizure (\<12 hrs)
Other
- Patient confined to be more than 50% of waking hours
- 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
Who the study is looking for
- 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))
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AP-HP - hôpital Raymond Poincaré Coordinator of this site? Confirm its status | Garches | France | Recruiting |
| AP-HP Hopital Bicetre Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Recruiting |
| Fondation Ophtalmologique Rothschild Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| AP-HP, Hôpital de la Pitié Salpêtrière Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| BSPP, Brigade des Sapeurs-Pompiers de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| AP-HP Hôpital Bichat Claude-Bernard Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| AP-HP Hopital Lariboisiere Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| GHU Paris Psychiatrie & Neurosciences Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hopital Saint Joseph Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| SAMU 75 de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hopital Foch Coordinator of this site? Confirm its status | Suresnes | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.