Ischemic StrokeARTIFICENCT07420374
Ambulatory Stroke Unit Treatment for Elderly Patients
A study testing Ambulatory Stroke Unit Care and Conventional Stroke Unit Care in people with Ischemic Stroke and Transient Ischemic Attack (TIA), run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Ischemic Stroke, Transient Ischemic Attack (TIA), Retinal Ischemia
- What is being tested?
- Ambulatory Stroke Unit Care and Conventional Stroke Unit Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- 25 Mar 2026to Dec 2028
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Heidelberg University Hospital
Heidelberg, 69120
Dorit Arlt, Dr., +49 6221 56 6999, neurologie@med.uni-heidelberg.de
About this study
Official title: Ambulatory Stroke Unit Treatment for Elderly Patients: A Prospective, Randomized, Controlled, Exploratory Non-Inferiority Trial (ARTIFICE)
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.
Read the detailed description
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.
- Being tested
- Ambulatory Stroke Unit Care, Conventional Stroke Unit Care
- Keywords
- Ambulatory Stroke Unit, Stroke Unit Care, Minor Stroke, Transient Ischemic Attack, Geriatric Stroke, Non-Inferiority Trial, Health Services Research, Care Delivery Model, Integrated Stroke Care, Post-Stroke Outcome, Modified Rankin Scale, Quality of Life, Cost-Effectiveness, Stroke Recurrence, Delirium
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory Stroke Unit CareOther
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.
Conventional Stroke Unit CareOther
Standard inpatient stroke unit treatment according to national clinical guidelines, including hospital-based monitoring, diagnostic evaluation, and initiation of secondary prevention.
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory Stroke Unit Care (aSU) | Experimental | 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. Receives: Other: Ambulatory Stroke Unit Care |
| Inpatient Stroke Unit Care (SU) | Active comparator | Participants receive guideline-based inpatient stroke unit treatment according to standard clinical practice, including monitoring and diagnostic evaluation during hospital admission. Receives: Other: Conventional Stroke Unit Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days (±14 days) after randomization
Secondary outcomes (10)
Early Neurological Deterioration
Increase in National Institutes of Health Stroke Scale (NIHSS) score of ≥4 points compared to baseline.
Measured: Within 7 days after randomization
Recurrent Stroke
Occurrence of recurrent ischemic stroke, hemorrhagic stroke, or transient ischemic attack during follow-up.
Measured: Up to 90 days after randomization (primary safety observation period)
Delirium Occurrence
Occurrence of delirium assessed using the Confusion Assessment Method (CAM).
Measured: Within 7 days after randomization
All-Cause Mortality
Death from any cause.
Measured: 90 days and 12 months after randomization
Functional Status
Change in Barthel Index score from baseline to 90 days.
Measured: Baseline and 90 days
Stroke Impact
Change in SIS-16 score from baseline to 90 days.
Measured: Baseline and 90 days
Mobility
Change in Timed Up and Go Test (TUG) time from baseline to 90 days.
Measured: 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.
Measured: Baseline and 90 days
Healthcare Utilization
Use of outpatient, inpatient, and nursing care services assessed by questionnaire.
Measured: Up to 90 days after randomization
Serious Adverse Events
Occurrence of serious adverse events including unplanned hospitalization or death.
Measured: Up to 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start25 Mar 2026
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants aged ≥60 years with acute ischemic stroke, transient ischemic attack, or retinal ischemia and non-disabling neurological deficits are randomized 1:1 to ambulatory stroke unit care or guideline-based inpatient stroke unit care after confirmation that both treatment settings are medically feasible. Randomization is computer-generated, block-based, and stratified by baseline modified Rankin Scale (0-3 vs 4-5).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf, inav - Institute for Applied Health Services Research GmbH, Berlin, Germany
- Responsible party
- Principal investigator, Dr. Jan Christoph Purrucker, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420374
- Sponsor's protocol ID
- S-689/2025 (ARTIFICE)
- Other IDs
- 01NVF24306
- Acronym
- ARTIFICE
- Status last verified
- Mar 2026
- First submitted
- 12 Feb 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Stroke Unit Treatment for Elderly Patients: A Prospective, Randomized, Controlled, Exploratory Non-Inferiority Trial (ARTIFICE)
- ClinicalTrials.gov ID
- NCT07420374
- Acronym / sponsor ID
- ARTIFICE / S-689/2025 (ARTIFICE)
- Keywords
- Ambulatory Stroke Unit, Stroke Unit Care, Minor Stroke, Transient Ischemic Attack, Geriatric Stroke, Non-Inferiority Trial, Health Services Research, Care Delivery Model
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf, inav - Institute for Applied Health Services Research GmbH, Berlin, Germany
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Feb 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants aged ≥60 years with acute ischemic stroke, transient ischemic attack, or retinal ischemia and non-disabling neurological deficits are randomized 1:1 to ambulatory stroke unit care or guideline-based inpatient stroke unit care after confirmation that both treatment settings are medically feasible. Randomization is computer-generated, block-based, and stratified by baseline modified Rankin Scale (0-3 vs 4-5).
| Arm | Type | Receives |
|---|---|---|
| Ambulatory Stroke Unit Care (aSU) | Experimental | Other: Ambulatory Stroke Unit CareParticipants 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. |
| Inpatient Stroke Unit Care (SU) | Active comparator | Other: Conventional Stroke Unit CareParticipants receive guideline-based inpatient stroke unit treatment according to standard clinical practice, including monitoring and diagnostic evaluation during hospital admission. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Ambulatory Stroke Unit CareStructured 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. | Other | Ambulatory Stroke Unit Care (aSU) |
| Conventional Stroke Unit CareStandard inpatient stroke unit treatment according to national clinical guidelines, including hospital-based monitoring, diagnostic evaluation, and initiation of secondary prevention. | Other | Inpatient Stroke Unit Care (SU) |
Primary outcome
Favorable Functional Outcome at 90 Days
Time frame: 90 days (±14 days) after randomization
Favorable functional outcome defined as modified Rankin Scale (mRS) score 0-2 or return to pre-stroke mRS level, assessed by blinded outcome assessors.
10 secondary outcomes
Early Neurological Deterioration
Time frame: Within 7 days after randomization
Recurrent Stroke
Time frame: Up to 90 days after randomization (primary safety observation period)
Delirium Occurrence
Time frame: Within 7 days after randomization
All-Cause Mortality
Time frame: 90 days and 12 months after randomization
Functional Status
Time frame: Baseline and 90 days
Stroke Impact
Time frame: Baseline and 90 days
Mobility
Time frame: Baseline and 90 days
Health-Related Quality of Life
Time frame: Baseline and 90 days
Healthcare Utilization
Time frame: Up to 90 days after randomization
Serious Adverse Events
Time frame: Up to 90 days after 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 31 Mar 2026.
- Individual participant dataSharing planned: 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory Stroke Unit Care and Conventional Stroke Unit Care in people with Ischemic Stroke and Transient Ischemic Attack (TIA), run by University Hospital Heidelberg at 1 site in Germany.
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 5 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 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 Jan C Purrucker, Prof. Dr. (+49 6221 56 6999, artifice.studie@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Favorable Functional Outcome at 90 Days (time frame: 90 days (±14 days) after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2026.