NCT07420374Recruiting
Ambulatory Stroke Unit Treatment for Elderly Patients
Ambulatory Stroke Unit Treatment for Elderly Patients: A Prospective, Randomized, Controlled, Exploratory Non-Inferiority Trial (ARTIFICE)
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 12 Feb 2026
- Start date
- 25 Mar 2026
- Primary completion date
- Sept 2028
- Lead sponsor
- University Hospital Heidelberg
- Diseases
- Stroke
- NCT number
- NCT07420374
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 25 Mar 2026 to the primary completion date, Sept 2028
- 1 site 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.
Prior treatment
- Requirement for urgent surgical or interventional secondary prevention (e.g., carotid revascularization)
- Fluctuating stroke symptoms within the previous 48 hours
- Previous participation in the ambulatory stroke unit care model
Other illness
- Acute febrile infection or isolation-requiring infectious disease
Other
- Clinically relevant dysphagia with high aspiration risk
- Critical medical or nursing findings requiring mandatory multi-day inpatient treatment
- Palliative care situation with limitation of acute diagnostic or therapeutic measures
- No statutory health insurance coverage in Germany
- Insufficient German language proficiency to understand study procedures and assessments
Who the study is looking for
- 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
- Written informed consent provided by the participant or, if lacking decision-making capacity, by a legally authorized representative
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Heidelberg University Hospital Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.