Ambulatory Stroke Unit Treatment for Elderly Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity Hospital Heidelberg
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 60 years
Diagnosis of acute ischemic stroke (ICD-10 I63.), transient ischemic attack (G45.), or retinal ischemia (H34.*)
Symptom onset ≤ 7 days before enrollment
No or non-disabling newly occurring neurological deficit allowing safe ambulatory management
Disqualifiers
Requirement for urgent surgical or interventional secondary prevention (e.g., carotid revascularization)
Fluctuating stroke symptoms within the previous 48 hours
Acute febrile infection or isolation-requiring infectious disease
Clinically relevant dysphagia with high aspiration risk
Trial design
Design model
Parallel
Treatments tested in this trial
Ambulatory Stroke Unit Care
Other interventionStructured 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.
Conventional Stroke Unit Care
Other interventionStandard inpatient stroke unit treatment according to national clinical guidelines, including hospital-based monitoring, diagnostic evaluation, and initiation of secondary prevention.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Ambulatory Stroke Unit Care (aSU)Experimental treatment 1 intervention
Group B: Inpatient Stroke Unit Care (SU)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 randomizationSecondary outcomes
1
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 randomization2
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)3
Delirium Occurrence
Occurrence of delirium assessed using the Confusion Assessment Method (CAM).
Time frame
Within 7 days after randomization4
All-Cause Mortality
Death from any cause.
Time frame
90 days and 12 months after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Heidelberg
Lead sponsor
Heinrich-Heine University, Duesseldorf
Collaborator
inav - Institute for Applied Health Services Research GmbH, Berlin, Germany
Collaborator
Source ClinicalTrials.gov