Condition: Ischemic Stroke · Transient Ischemic Attack (TIA) · Retinal Ischemia · Sponsor: University Hospital Heidelberg
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.
This description comes directly from the study's public registry record.
Jan C Purrucker, Prof. Dr. · +49 6221 56 6999 · artifice.studie@med.uni-heidelberg.de
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| Heidelberg University Hospital | Heidelberg, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07420374