No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
60 and older
Sex
Any
Study type
Interventional
Purpose
Health Services Research
Participants needed
400 (estimated)
Sponsor
University Hospital Heidelberg · Other
Who this trial is looking for
This trial is looking for people aged 60 and older who have had a recent stroke, transient ischemic attack or retinal ischemia. Participants will either receive treatment in an ambulatory unit or in a hospital, and their outcomes will be monitored over 90 days.
Are You a Good Fit for This Trial?
You may be able to join if
I am 60 years old or older.
I have been diagnosed with acute ischemic stroke, TIA, or retinal ischemia.
My symptoms started within the last 7 days.
I have no serious neurological deficits that prevent me from being safely treated as an outpatient.
I can give written consent or my representative can do it for me.
You may not be able to join if
I need urgent surgery or intervention for my condition.
My stroke symptoms have been changing or fluctuating in the last 48 hours.
I currently have a serious infection.
I have trouble swallowing that puts me at high risk for choking.
My medical condition requires me to stay in the hospital for several days.
I am in palliative care and cannot undergo acute treatment.
I have already participated in this ambulatory treatment before.
I do not have health insurance in Germany.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 r…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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…
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Critical medical or nursing findings requiring mandatory multi-day inpatient treatment
* Palliative care situation with limitation of acute diagnostic or therapeutic measures
* Previous participation in the ambulatory stroke unit care model
* No statutory health insurance coverage in Germany
* Insufficient German language proficiency to understand study procedures and assessments
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