Stroke, AcuteASPHALTNCT05649670
Acute Stroke: Prehospital Versus In-HospitAL Initiation of Recanalization Therapy- ASPHALT
A study testing Mobile Stroke Unit deployment in people with Stroke, Acute, run by Centre Hospitalier St Anne at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Mobile Stroke Unit deployment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 11 sitesFrance
- Study dates
- 16 Oct 2023to 16 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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))
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
AP-HP - hôpital Raymond Poincaré
Garches, 92380
Sandrine Deltour, MD, sandrine.deltour@aphp.fr
- Recruiting
AP-HP - hôpital Bicêtre
Le Kremlin-Bicêtre, 94275
Christian DENIER, MD, PhD, +33 (0) 145 21 24 03, christian.denier@aphp.fr
- Recruiting
AP-HP - hôpital Lariboisière
Paris, 75010
Mikaël MAZIGHI, MD, PhD, +33 (0)1 49 95 25 97, mmazighi@for.paris
- Recruiting
AP-HP - hôpital de la Pitié-Salpêtrière
Paris, 75013
Sonia ALAMOWITCH, MD, PhD, +33 (0)1 71 97 06 51, sonia.alamowitch@aphp.fr
- Recruiting
GHU Paris psychiatrie & neurosciences
Paris, 75014
Guillaume TURC, MD, PhD, +33 (0)1 45 65 85 65, g.turc@ghu-paris.fr
- Recruiting
SAMU 75 de Paris
Paris, 75015
Benoît VIVIEN, MD, PhD, +33 (0)1 44 49 24 75, benoit.vivien@aphp.fr
- Recruiting
BSPP, Brigade des Sapeurs-Pompiers de Paris
Paris, 75017
Caterina ZAMPIERI, MD, +33 (0)6 51 15 13 42, zampiericaterina@gmail.com
- Recruiting
AP-HP - hôpital Bichat - Claude-Bernard
Paris, 75018
Phlippa LAVALLEE, MD, philippa.lavallee@aphp.fr
- Recruiting
Fondation Ophtalmologique Rothschild
Paris, 75019
Michaël OBADIA, MD, +33 (0)1 48 03 68 52, mobadia@for.paris
- Not yet recruiting
Hôpital Saint Joseph
Paris, 75674
Mathieu ZUBER, MD, PhD, +33 (0)1 44 12 34 09, mzuber@ghpsj.fr
- Recruiting
Hôpital Foch
Suresnes, 92151
Bertrand LAPERGUE, MD, +33 (1) 46 25 59 73, b.lapergue@hopital-foch.org
About this study
Official title: Prehospital Initiation of Reperfusion Therapy for Acute Ischemic Stroke: Randomized Medico-economic Evaluation of a Mobile Stroke Unit.
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.
Read the detailed description
Instead of the traditional approach of waiting until the patient arrives at the hospital to perform brain imaging and start reperfusion therapies, mobile stroke units (MSUs; ambulances equipped with a CT scanner) now allow pre-hospital initiation of intravenous thrombolysis (IVT). Two large non-randomized clinical trials (B_PROUD \& BEST-MSU) have recently shown that MSU use leads to improved functional outcomes at 3 months in specific settings. However, MSUs have been criticized because of their cost and a lack of evidence of a significant reduction in the time between symptom onset and mechanical thrombectomy, which is the cornerstone of treatment of patients with large vessel occlusion.
We hypothesized that compared to usual care, the deployment of a MSU would result in an incremental cost-utility ratio ≤50,000 euros per QALY in the lifetime horizon, even in an area with many thrombectomy-capable centers..
Academic-driven open-label randomized controlled trial of Mobile Stroke Unit (MSU) deployment versus standard care in France, with blinded assessment of efficacy endpoints. Randomization will be performed on an individual patient basis (randomization of MSU deployment at dispatch). 450 patients with confirmed acute ischemic stroke (emergency call ≤6 hours after onset) will be recruited over a 3-year period, with 3-month follow-up. Costs and clinical outcomes will be collected prospectively during the study period and used to extrapolate the incremental cost-utility ratio over a lifetime horizon.
- Conditions
- Stroke, Acute
- Being tested
- Mobile Stroke Unit deployment
- Keywords
- Mobile Stroke Unit, MSU, Intravenous thrombolysis, Emergency Medical Service, Mechanical thrombectomy, Cost-utility, Cost-effectiveness
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Stroke Unit deploymentOther
Also called Mobile Stroke Unit management
Deployment of an MSU + conventional ambulance, allowing prehospital CT-scan imaging with intracranial CT angiography. This will allow prehospital intravenous thrombolysis and optimal triage (i.e. accurate identification of patients with large vessel occlusion, who are eligible for mechanical thrombectomy).
| Study group | Role | What they receive |
|---|---|---|
| Intervention (MSU) | Experimental | Deployment of MSU + conventional ambulance Receives: Other: Mobile Stroke Unit deployment |
| Control (usual care) | No intervention | Deployment of conventional ambulance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Cost-Utility Ratio (ICUR)
ICUR in the lifetime horizon, based on extrapolated results of the Modified Rankin Scale (mRS) at 3 months and incremental costs prospectively collected during the first 3 months
Measured: 3 months
Key secondary outcome: Modified Rankin Scale (mRS) at 3 months
Modified Rankin scale, assessed in a blinded fashion (range, 0 to 6, with 0 indicating no disability, 3 indicating moderate disability, and 6 indicating death)
Measured: 90 +/- 14 days
Secondary outcomes (12)
ICUR at 3 months
Incremental Cost-Utility Ratio based on results of the Modified Rankin Scale (mRS) at 3 months and incremental costs prospectively collected during the first 3 months
Measured: 90 +/- 14 days
ICUR at 5 years
Incremental Cost-Utility Ratio based on extrapolated results of the Modified Rankin Scale (mRS) at 3 months and incremental costs prospectively collected during the first 3 months
Measured: 5 years
Time from symptom onset to intravenous thrombolysis (IVT)
Time from symptom onset to IVT bolus
Measured: up to 4.5 hours from symptom onset
Time from symptom onset to mechanical thrombectomy (MT)
Time from symptom onset to arterial puncture
Measured: up to 24 hours from symptom onset
Time from alarm to IVT
Time from ambulance dispatch to IVT bolus
Measured: up to 4.5 hours from symptom onset
Time from alarm to MT
Time from ambulance dispatch to arterial puncture
Measured: up to 24 hours from symptom onset
Death within 3 months after randomization
All-cause mortality
Measured: Within 90 days after randomization
Death within 7 days after randomization
All-cause mortality
Measured: Within 7 days after randomization
Proportion of ischemic stroke patients treated with IVT
Proportion of patient treated with IVT among those with confirmed ischemic stroke
Measured: up to 4.5 hours from symptom onset
Proportion of ischemic stroke patients with MT
Proportion of patient treated with MT among those with confirmed ischemic stroke
Measured: up to 24 hours from symptom onset
Proportion of ischemic stroke patients treated with IVT within 60 minutes of symptom onset
Golden hour thrombolysis
Measured: within 60 minutes of symptom onset
Symptomatic intracranial hemorrhage
ECASS-2 definition
Measured: Within 36 hours from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start16 Oct 2023
- Primary completion16 Oct 2026 (estimated)
- Study completion16 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial, PROBE design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris, Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Guillaume TURC, MD, PhD, Principal investigator, GHU Paris Psychiatrie et NeurosciencesBenoît VIVIEN, MD, PhD, Study director, APHP - Centre Hospitalier Universitaire Necker
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649670
- Sponsor's protocol ID
- 2018-A02567-48
- Other IDs
- PRME 15-0677
- Acronym
- ASPHALT
- Status last verified
- Oct 2023
- First submitted
- 2 Dec 2022
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) could be available to other researcher aiming to conduct an IPD-meta analysis of studies of MSU vs. usual care (please see access criteria below).
Publications
Turc G, Hadziahmetovic M, Walter S, Churilov L, Larsen K, Grotta JC, Yamal JM, Bowry R, Katsanos AH, Zhao H, Donnan G, Davis SM, Hussain MS, Uchino K, Helwig SA, Johns H, Weber JE, Nolte CH, Kunz A, Steiner T, Sacco S, Ebinger M, Tsivgoulis G, Fassbender K, Audebert HJ. Comparison of Mobile Stroke Unit With Usual Care for Acute Ischemic Stroke Management: A Systematic Review and Meta-analysis. JAMA Neurol. 2022 Mar 1;79(3):281-290. doi: 10.1001/jamaneurol.2021.5321.
PubMed 35129584
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Initiation of Reperfusion Therapy for Acute Ischemic Stroke: Randomized Medico-economic Evaluation of a Mobile Stroke Unit.
- ClinicalTrials.gov ID
- NCT05649670
- Acronym / sponsor ID
- ASPHALT / 2018-A02567-48
- Conditions
- Stroke, Acute
- Keywords
- Mobile Stroke Unit, MSU, Intravenous thrombolysis, Emergency Medical Service, Mechanical thrombectomy, Cost-utility, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris, Ministry of Health, France
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 16 Oct 2026 (estimated)
- Study completion
- 16 Jun 2027 (estimated)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Instead of the traditional approach of waiting until the patient arrives at the hospital to perform brain imaging and start reperfusion therapies, mobile stroke units (MSUs; ambulances equipped with a CT scanner) now allow pre-hospital initiation of intravenous thrombolysis (IVT). Two large non-randomized clinical trials (B_PROUD \& BEST-MSU) have recently shown that MSU use leads to improved functional outcomes at 3 months in specific settings. However, MSUs have been criticized because of their cost and a lack of evidence of a significant reduction in the time between symptom onset and mechanical thrombectomy, which is the cornerstone of treatment of patients with large vessel occlusion.
We hypothesized that compared to usual care, the deployment of a MSU would result in an incremental cost-utility ratio ≤50,000 euros per QALY in the lifetime horizon, even in an area with many thrombectomy-capable centers..
Academic-driven open-label randomized controlled trial of Mobile Stroke Unit (MSU) deployment versus standard care in France, with blinded assessment of efficacy endpoints. Randomization will be performed on an individual patient basis (randomization of MSU deployment at dispatch). 450 patients with confirmed acute ischemic stroke (emergency call ≤6 hours after onset) will be recruited over a 3-year period, with 3-month follow-up. Costs and clinical outcomes will be collected prospectively during the study period and used to extrapolate the incremental cost-utility ratio over a lifetime horizon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial, PROBE design
| Arm | Type | Receives |
|---|---|---|
| Intervention (MSU) | Experimental | Other: Mobile Stroke Unit deploymentDeployment of MSU + conventional ambulance |
| Control (usual care) | No intervention | –Deployment of conventional ambulance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Stroke Unit deploymentAlso: Mobile Stroke Unit managementDeployment of an MSU + conventional ambulance, allowing prehospital CT-scan imaging with intracranial CT angiography. This will allow prehospital intravenous thrombolysis and optimal triage (i.e. accurate identification of patients with large vessel occlusion, who are eligible for mechanical thrombectomy). | Other | Intervention (MSU) |
Primary outcome
Incremental Cost-Utility Ratio (ICUR)
Time frame: 3 months
ICUR in the lifetime horizon, based on extrapolated results of the Modified Rankin Scale (mRS) at 3 months and incremental costs prospectively collected during the first 3 months
Key secondary outcome: Modified Rankin Scale (mRS) at 3 months
Time frame: 90 +/- 14 days
Modified Rankin scale, assessed in a blinded fashion (range, 0 to 6, with 0 indicating no disability, 3 indicating moderate disability, and 6 indicating death)
12 secondary outcomes
ICUR at 3 months
Time frame: 90 +/- 14 days
ICUR at 5 years
Time frame: 5 years
Time from symptom onset to intravenous thrombolysis (IVT)
Time frame: up to 4.5 hours from symptom onset
Time from symptom onset to mechanical thrombectomy (MT)
Time frame: up to 24 hours from symptom onset
Time from alarm to IVT
Time frame: up to 4.5 hours from symptom onset
Time from alarm to MT
Time frame: up to 24 hours from symptom onset
Death within 3 months after randomization
Time frame: Within 90 days after randomization
Death within 7 days after randomization
Time frame: Within 7 days after randomization
Proportion of ischemic stroke patients treated with IVT
Time frame: up to 4.5 hours from symptom onset
Proportion of ischemic stroke patients with MT
Time frame: up to 24 hours from symptom onset
Proportion of ischemic stroke patients treated with IVT within 60 minutes of symptom onset
Time frame: within 60 minutes of symptom onset
Symptomatic intracranial hemorrhage
Time frame: Within 36 hours from randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Background: PubMed 35129584Turc G, Hadziahmetovic M, Walter S, Churilov L, Larsen K, Grotta JC, Yamal JM, Bowry R, Katsanos AH, Zhao H, Donnan G, Davis SM, Hussain MS, Uchino K, Helwig SA, Johns H, Weber JE, Nolte CH, Kunz A, Steiner T, Sacco S, Ebinger M, Tsivgoulis G, Fassbender K, Audebert HJ. Comparison of Mobile Stroke Unit With Usual Care for Acute Ischemic Stroke Management: A Systematic Review and Meta-analysis. JAMA Neurol. 2022 Mar 1;79(3):281-290. doi: 10.1001/jamaneurol.2021.5321.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) could be available to other researcher aiming to conduct an IPD-meta analysis of studies of MSU vs. usual care (please see access criteria below).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillaume TURC, MD, PhD principal investigator
GHU Paris Psychiatrie et Neurosciences
Benoît VIVIEN, MD, PhD study director
APHP - Centre Hospitalier Universitaire Necker
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Stroke Unit deployment in people with Stroke, Acute, run by Centre Hospitalier St Anne at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khaoussou SYLLA, MD, PhD (+33 (01) 45 65 76 78, k.sylla@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental Cost-Utility Ratio (ICUR) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05649670, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.