An interventional study of Ambulatory Stroke Unit Care and Conventional Stroke Unit Care in Ischemic Stroke, Transient Ischemic Attack (TIA) and Retinal Ischemia, sponsored by University Hospital Heidelberg. Recruiting at 1 site in Germany. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by University Hospital Heidelberg · Not applicable, Interventional, and Health services research
ARTIFICE is a prospective, multicenter, randomized, controlled, exploratory non-inferiority trial evaluating whether an ambulatory stroke unit model (aSU) is non-inferior to conventional inpatient stroke unit care (SU) in patients aged 60 years or older with acute ischemic stroke, transient ischemic attack (TIA), or retinal ischemia and non-disabling neurological deficits.
Eligible patients are randomized 1:1 to same-day comprehensive ambulatory multiprofessional stroke evaluation (aSU) or guideline-based inpatient stroke unit treatment (SU). The primary endpoint is favorable functional outcome at 90 days, defined as modified Rankin Scale (mRS) 0-2 or return to pre-stroke mRS. Endpoint assessment at 90 days is performed by blinded assessors (PROBE design).
Secondary outcomes include early neurological deterioration, recurrent stroke, delirium, mortality, health-related quality of life, healthcare utilization, and cost-effectiveness. A mixed-methods process evaluation examines feasibility, acceptability, and implementation aspects of the ambulatory care model.
Stroke unit treatment in Germany is currently organized as multi-day inpatient care regardless of stroke severity. However, a substantial proportion of patients with acute ischemic stroke or transient ischemic attack present with non-disabling or fully regressed neurological deficits and may not require prolonged inpatient monitoring. At the same time, demographic changes and increasing stroke incidence in older populations challenge inpatient stroke unit capacity and resource allocation.
International experience with structured outpatient TIA and minor stroke clinics suggests that ambulatory management models may provide comparable clinical safety while reducing hospital utilization. However, randomized evidence for such models within the German healthcare system is lacking.
The ARTIFICE trial evaluates a structured ambulatory stroke unit care model designed to provide comprehensive same-day multiprofessional assessment and initiation of secondary prevention while maintaining patient safety. The study investigates whether this ambulatory care approach can represent a medically safe and resource-efficient alternative to conventional inpatient stroke unit treatment in selected older patients.
In addition to clinical effectiveness, the study examines patient-reported outcomes, healthcare utilization, cost-effectiveness, and implementation aspects to inform future health services planning.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 400 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →University Hospital Heidelberg is the lead sponsor of 177 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive structured ambulatory stroke unit care consisting of comprehensive same-day multiprofessional assessment, diagnostic evaluation, and initiation of secondary prevention. After evaluation, clinically stable participants are discharged home with structured follow-up.
Other: Ambulatory Stroke Unit Care
Participants receive guideline-based inpatient stroke unit treatment according to standard clinical practice, including monitoring and diagnostic evaluation during hospital admission.
Other: Conventional Stroke Unit Care
Structured ambulatory stroke care model providing same-day neurological assessment, diagnostic work-up, therapeutic evaluation, and multidisciplinary case review, followed by discharge home if medically appropriate.
Standard inpatient stroke unit treatment according to national clinical guidelines, including hospital-based monitoring, diagnostic evaluation, and initiation of secondary prevention.
Favorable Functional Outcome at 90 Days
Favorable functional outcome defined as modified Rankin Scale (mRS) score 0-2 or return to pre-stroke mRS level, assessed by blinded outcome assessors.
Time frame: 90 days (±14 days) after randomization
Early Neurological Deterioration
Increase in National Institutes of Health Stroke Scale (NIHSS) score of ≥4 points compared to baseline.
Time frame: Within 7 days after randomization
Recurrent Stroke
Occurrence of recurrent ischemic stroke, hemorrhagic stroke, or transient ischemic attack during follow-up.
Time frame: Up to 90 days after randomization (primary safety observation period)
Delirium Occurrence
Occurrence of delirium assessed using the Confusion Assessment Method (CAM).
Time frame: Within 7 days after randomization
All-Cause Mortality
Death from any cause.
Time frame: 90 days and 12 months after randomization
Functional Status
Change in Barthel Index score from baseline to 90 days.
Time frame: Baseline and 90 days
Stroke Impact
Change in SIS-16 score from baseline to 90 days.
Time frame: Baseline and 90 days
Mobility
Change in Timed Up and Go Test (TUG) time from baseline to 90 days.
Time frame: Baseline and 90 days
Health-Related Quality of Life
Change in EQ-5D-5L index value and EQ visual analogue scale (EQ-VAS) from baseline to 90 days.
Time frame: Baseline and 90 days
Healthcare Utilization
Use of outpatient, inpatient, and nursing care services assessed by questionnaire.
Time frame: Up to 90 days after randomization
Serious Adverse Events
Occurrence of serious adverse events including unplanned hospitalization or death.
Time frame: Up to 90 days after randomization
Plan to share: No — Individual participant data will not be made publicly available. De-identified data may be shared with qualified researchers upon reasonable request, subject to approval by the sponsor and in accordance with applicable data protection regulations (including GDPR), institutional policies, and a data use agreement.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital Heidelberg →