Ambulatory Stroke Unit Treatment for Elderly Patients

NCT07420374 | Recruiting DMC

• 2 other identifiers: S-689/2025 (ARTIFICE)01NVF24306
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Ischemic Stroke; Transient Ischemic Attack (TIA); Retinal Ischemia

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

Outcome Measures

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.

  90 days (±14 days) after randomization

Secondary Outcomes (10)

• Early Neurological Deterioration

  Within 7 days after randomization

• Recurrent Stroke

  Up to 90 days after randomization (primary safety observation period)

• Delirium Occurrence

  Within 7 days after randomization

• All-Cause Mortality

  90 days and 12 months after randomization

• Functional Status

  Baseline and 90 days

Study Arms (2)

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.

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.

Other: Conventional Stroke Unit Care

Interventions

Ambulatory Stroke Unit Care OTHER

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.

Ambulatory Stroke Unit Care (aSU)

Conventional Stroke Unit Care OTHER

Standard inpatient stroke unit treatment according to national clinical guidelines, including hospital-based monitoring, diagnostic evaluation, and initiation of secondary prevention.

Inpatient Stroke Unit Care (SU)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• Heidelberg University Hospital - Coordination Centre for Clinical Trials (KKS): collaborator
• inav - Institute for Applied Health Services Research GmbH, Berlin, Germany: collaborator

Study Sites (1)

Heidelberg University Hospital

Heidelberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient; Delirium

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Jan C Purrucker, Prof. Dr.

CONTACT

+49 6221 56 6999; artifice.studie@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an open-label study due to the nature of the care setting. Outcome assessment at 90 days is performed by independent study personnel who are blinded to treatment allocation (PROBE design).
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Jan Purrucker

Model Details: 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).

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)