Ambulatory Stroke Unit Treatment for Elderly Patients

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.

NCT Number	NCT07420374
Lead Sponsor	University Hospital Heidelberg Collaborators: Heinrich-Heine University, Duesseldorf, inav - Institute for Applied Health Services Research GmbH, Berlin, Germany
Conditions	Ischemic Stroke, Transient Ischemic Attack (TIA), Retinal Ischemia
Enrollment	400 participants
Start Date	2026-03-25
Primary Completion	2028-09 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2026-03-31